F18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
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ClinicalTrials.gov Identifier: NCT00721799 
Recruitment Status
:
Active, not recruiting
First Posted
: July 24, 2008
Results First Posted
: October 3, 2017
Last Update Posted
: October 3, 2017

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Study Type:  Interventional 

Study Design:  Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic 
Conditions: 
Mouth Neoplasms Oropharyngeal Neoplasms Laryngeal Neoplasms Head and Neck Neoplasms 
Intervention: 
Drug: 18FFluorothymidine PET scan 
Participant Flow
Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations 

No text entered. 
PreAssignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment 

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Reporting Groups
Description  

FLT PET 
Subjects who receive F18 Fluorothymidine [FLT]PET imaging prior to treatment. F18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%)] 
Participant Flow: Overall Study
FLT PET  

STARTED  33 
Recieved FLT PET Scan 1  26 
Received FLT PET Scan #2  25 
COMPLETED  25 
NOT COMPLETED  8 
Withdrawal by Subject  7 
withdraw by subject after scan 1  1 
Baseline Characteristics
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

No text entered. 
Reporting Groups
Description  

FLT PET 
Subjects who receive F18 Fluorothymidine [FLT]PET imaging prior to treatment. F18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%)] 
Baseline Measures
FLT PET  

Overall Participants Analyzed [Units: Participants] 
26  
Age [Units: Participants] Count of Participants 

<=18 years  0 0.0%  
Between 18 and 65 years  21 80.8%  
>=65 years  5 19.2%  
Age [Units: Years] Mean (Standard Deviation) 
57.8 (10.0)  
Sex: Female, Male [Units: Participants] Count of Participants 

Female  2 7.7%  
Male  24 92.3%  
Ethnicity (NIH/OMB) [Units: Participants] Count of Participants 

Hispanic or Latino  0 0.0%  
Not Hispanic or Latino  19 73.1%  
Unknown or Not Reported  7 26.9%  
Race (NIH/OMB) [Units: Participants] Count of Participants 

American Indian or Alaska Native  0 0.0%  
Asian  0 0.0%  
Native Hawaiian or Other Pacific Islander  0 0.0%  
Black or African American  0 0.0%  
White  23 88.5%  
More than one race  0 0.0%  
Unknown or Not Reported  3 11.5%  
Region of Enrollment [Units: Participants] 

United States  26  
Outcome Measures
1. Primary:  Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
4.23 (1.46) 
Statistical Analysis 1 for Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.08 
Hazard Ratio (HR) ^{[5]}  0.47 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.04 
Cstatistic ^{[5]}  0.73 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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2. Primary:  Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
6.36 (2.21) 
Statistical Analysis 1 for Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.05 
Hazard Ratio (HR) ^{[5]}  0.42 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.02 
Cstatistic ^{[5]}  0.75 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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3. Primary:  Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS) 
Measure Description  Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS) [Units: Mm^3 (cubic milimeters)] Mean (Standard Deviation) 
47.86 (32.49) 
Statistical Analysis 1 for Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  <0.01 
Hazard Ratio (HR) ^{[5]}  2.44 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.02 
Cstatistic ^{[5]}  0.74 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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4. Primary:  Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Progression Free Survival (PFS) [Units: mL/g/min] Mean (Standard Deviation) 
0.07 (0.03) 
Statistical Analysis 1 for Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.73 
Hazard Ratio (HR) ^{[5]}  1.12 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.88 
Cstatistic ^{[5]}  0.52 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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5. Primary:  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Progression Free Survival (PFS) [Units: L/min] Mean (Standard Deviation) 
0.04 (0.02) 
Statistical Analysis 1 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.78 
Hazard Ratio (HR) ^{[5]}  1.11 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.66 
Cstatistic ^{[5]}  0.45 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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6. Primary:  Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
143.68 (96.18) 
Statistical Analysis 1 for Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.01 
Hazard Ratio (HR) ^{[5]}  2.25 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.05 
Cstatistic ^{[5]}  0.70 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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7. Primary:  Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
2.53 (1.15) 
Statistical Analysis 1 for Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.63 
Hazard Ratio (HR) ^{[5]}  0.83 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.46 
Cstatistic ^{[5]}  0.58 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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8. Primary:  Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
3.85 (1.80) 
Statistical Analysis 1 for Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.58 
Hazard Ratio (HR) ^{[5]}  0.81 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.36 
Cstatistic ^{[5]}  0.60 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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9. Primary:  Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Progression Free Survival (PFS) [Units: mL/g/min] Mean (Standard Deviation) 
0.04 (0.02) 
Statistical Analysis 1 for Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.89 
Hazard Ratio (HR) ^{[5]}  0.94 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.42 
Cstatistic ^{[5]}  0.59 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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10. Primary:  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Progression Free Survival (PFS) [Units: L/min] Mean (Standard Deviation) 
0.02 (0.02) 
Statistical Analysis 1 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.43 
Hazard Ratio (HR) ^{[5]}  1.29 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.80 
Cstatistic ^{[5]}  0.47 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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11. Primary:  Efficacy of Midtherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Midtherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Midtherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
101.26 (76.91) 
Statistical Analysis 1 for Efficacy of Midtherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.01 
Hazard Ratio (HR) ^{[5]}  2.01 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Midtherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.07 
Cstatistic ^{[5]}  0.69 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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12. Primary:  Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS) [Units: Percentage change in SUVmean] Mean (Standard Deviation) 
0.39 (0.18) 
Statistical Analysis 1 for Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.18 
Hazard Ratio (HR) ^{[5]}  1.58 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.25 
Cstatistic ^{[5]}  0.63 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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13. Primary:  Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [Units: Percentage change in SUVmax] Mean (Standard Deviation) 
0.39 (0.20) 
Statistical Analysis 1 for Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.24 
Hazard Ratio (HR) ^{[5]}  1.49 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.27 
Cstatistic ^{[5]}  0.62 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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14. Primary:  Efficacy of Percent Change in FLT Flux (KFLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in FLT Flux (KFLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in FLT Flux (KFLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [Units: Percentage change in KFLT] Mean (Standard Deviation) 
0.33 (0.21) 
Statistical Analysis 1 for Efficacy of Percent Change in FLT Flux (KFLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.99 
Hazard Ratio (HR) ^{[5]}  1.00 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Percent Change in FLT Flux (KFLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.84 
Cstatistic ^{[5]}  0.48 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
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15. Primary:  Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [Units: Percentage change in KPatlak] Mean (Standard Deviation) 
0.51 (0.24) 
Statistical Analysis 1 for Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.41 
Hazard Ratio (HR) ^{[5]}  1.30 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.69 
Cstatistic ^{[5]}  0.54 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
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16. Primary:  Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of disease recurrence (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) [Units: Percentage change] Mean (Standard Deviation) 
0.34 (0.14) 
Statistical Analysis 1 for Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.17 
Hazard Ratio (HR) ^{[5]}  1.56 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.18 
Cstatistic ^{[5]}  0.64 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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17. Primary:  Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
4.23 (1.46) 
Statistical Analysis 1 for Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.09 
Hazard Ratio (HR) ^{[5]}  0.42 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Mean Pretherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.06 
Hazard Ratio (HR) ^{[5]}  0.72 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
18. Primary:  Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Progression free survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
6.36 (2.21) 
Statistical Analysis 1 for Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.06 
Hazard Ratio (HR) ^{[5]}  0.36 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Maximum Pretherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.04 
Cstatistic ^{[5]}  0.74 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
19. Primary:  Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Overall Survival (OS) 
Measure Description  Metabolic tumor volume using the FLT PET tracer. Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Overall Survival (OS) [Units: Mm^3 (cubic milimeters)] Mean (Standard Deviation) 
47.86 (32.49) 
Statistical Analysis 1 for Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  <0.01 
Hazard Ratio (HR) ^{[5]}  3.01 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Pretherapy Metabolic Tumor Volume in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  <0.01 
Cstatistic ^{[5]}  0.82 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
20. Primary:  Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate KFLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Overall Survival (OS) [Units: mL/g/min] Mean (Standard Deviation) 
0.07 (0.03) 
Statistical Analysis 1 for Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.92 
Hazard Ratio (HR) ^{[5]}  1.03 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of FLT Flux (KFLT) Pretherapy in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.84 
Cstatistic ^{[5]}  0.48 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
21. Primary:  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Overall Survival (OS) [Units: L/min] Mean (Standard Deviation) 
0.4 (0.2) 
Statistical Analysis 1 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.76 
Hazard Ratio (HR) ^{[5]}  1.11 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Pretherapy in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.68 
Cstatistic ^{[5]}  0.45 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
22. Primary:  Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 27 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the pretherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
27 
Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
143.68 (96.18) 
Statistical Analysis 1 for Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  <0.01 
Hazard Ratio (HR) ^{[5]}  2.99 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.03 
Cstatistic ^{[5]}  0.74 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
23. Primary:  Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
2.53 (1.15) 
Statistical Analysis 1 for Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.55 
Hazard Ratio (HR) ^{[5]}  0.78 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Mean Midtherapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.35 
Cstatistic ^{[5]}  0.61 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
24. Primary:  Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
3.85 (1.80) 
Statistical Analysis 1 for Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.48 
Hazard Ratio (HR) ^{[5]}  0.74 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Maximum Midtherapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.28 
Cstatistic ^{[5]}  0.63 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
25. Primary:  Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Overall Survival (OS). [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Overall Survival (OS). 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat).Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. FLT uptake in the tumor is a dynamic process that involves facilitated diffusion in and out of the cell and molecular changes in FLT. The rate KFLT, measured in mL/g/min, is a composite of the rate of transport of FLT from blood into the tissue and the transfer from tissue back into the blood, as well as the rate of molecular change of FLT. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Overall Survival (OS). [Units: mL/g/min] Mean (Standard Deviation) 
0.04 (0.02) 
Statistical Analysis 1 for Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Overall Survival (OS).
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.67 
Hazard Ratio (HR) ^{[5]}  0.81 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of FLT Flux (KFLT) Midtherapy in Predicting Overall Survival (OS).
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.11 
Cstatistic ^{[5]}  0.71 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
26. Primary:  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. The Patlak influx rate, measured in l /min, is the rate of transport of FLT from blood into the tissue as well as the rate of molecular change of FLT, using a Patlak analysis. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Overall Survival (OS) [Units: L/min] Mean (Standard Deviation) 
0.02 (0.02) 
Statistical Analysis 1 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.40 
Hazard Ratio (HR) ^{[5]}  1.32 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of the Patlak Influx Rate Constant for FLT (KPatlak) Midtherapy in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.88 
Cstatistic ^{[5]}  0.48 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
27. Primary:  Efficacy of Midtherapy Total Lesion Proliferation in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Midtherapy Total Lesion Proliferation in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent the midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Midtherapy Total Lesion Proliferation in Predicting Overall Survival (OS) [Units: Standardized uptake value (SUV)] Mean (Standard Deviation) 
101.26 (76.91) 
Statistical Analysis 1 for Efficacy of Midtherapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  <0.01 
Hazard Ratio (HR) ^{[5]}  2.39 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
Statistical Analysis 2 for Efficacy of Midtherapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.03 
Cstatistic ^{[5]}  0.74 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

No text entered.  
[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
No text entered.  
[3]  Other relevant method information, such as adjustments or degrees of freedom: 
No text entered.  
[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
No text entered.  
[5]  Other relevant estimation information: 
No text entered. 
28. Primary:  Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS) [Units: Percentage change in SUVmean] Mean (Standard Deviation) 
0.39 (0.18) 
Statistical Analysis 1 for Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.26 
Hazard Ratio (HR) ^{[5]}  1.51 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.46 
Cstatistic ^{[5]}  0.59 
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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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29. Primary:  Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS) [Units: Percentage change in SUVmax] Mean (Standard Deviation) 
0.39 (0.20) 
Statistical Analysis 1 for Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.37 
Hazard Ratio (HR) ^{[5]}  1.38 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.46 
Cstatistic ^{[5]}  0.59 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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30. Primary:  Efficacy of Percent Change in FLT Flux (KFLT) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in FLT Flux (KFLT) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in FLT Flux (KFLT) in Predicting Overall Survival (OS) [Units: Percentage change in KFLT] Mean (Standard Deviation) 
0.33 (0.21) 
Statistical Analysis 1 for Efficacy of Percent Change in FLT Flux (KFLT) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.90 
Hazard Ratio (HR) ^{[5]}  1.05 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change in FLT Flux (KFLT) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.87 
Cstatistic ^{[5]}  0.52 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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31. Primary:  Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) in Predicting Overall Survival (OS) [Units: Percentage change in KPatlak] Mean (Standard Deviation) 
0.51 (0.24) 
Statistical Analysis 1 for Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.36 
Hazard Ratio (HR) ^{[5]}  1.35 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (KPatlak) in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.63 
Cstatistic ^{[5]}  0.56 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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32. Primary:  Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS) [ Time Frame: 36 months ] 
Measure Type  Primary 

Measure Title  Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS) 
Measure Description  Prediction efficacy is estimated using a hazard ratio (HR) and Cstatistic (Cstat). Overall survival is defined as the span of time from day 1 of therapy to date of death from any cause (measured in months). Results are pooled with subjects from a pilot RDRC study for a total of 25 subjects analyzed. 
Time Frame  36 months 
Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. 

Participants who underwent both the pretherapy and midtherapy FLT PET scan 
Reporting Groups
Description  

FLT PET Scan 
Subjects receive 2 18FFluorothymidine PET scans
F18 Fluorothymidine dose = 0.04 to 0.08 mCi/kg (maximum of 5 mCi +/ 10%). Imaging technology: PET scan 
Measured Values
FLT PET Scan  

Participants Analyzed [Units: Participants] 
25 
Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS) [Units: Percentage change] Mean (Standard Deviation) 
0.34 (0.14) 
Statistical Analysis 1 for Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.20 
Hazard Ratio (HR) ^{[5]}  1.56 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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[5]  Other relevant estimation information: 
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Statistical Analysis 2 for Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)
Groups ^{[1]}  FLT PET Scan 

Statistical Test Type ^{[2]}  Other 
Statistical Method ^{[3]}  Regression, Cox 
P Value ^{[4]}  0.24 
Cstatistic ^{[5]}  0.63 
[1]  Additional details about the analysis, such as null hypothesis and power calculation: 

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[2]  Details of power calculation, definition of noninferiority margin, and other key parameters: 
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[3]  Other relevant method information, such as adjustments or degrees of freedom: 
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[4]  Additional information, such as whether or not the pvalue is adjusted for multiple comparisons and the a priori threshold for statistical significance: 
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Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data 


More Information
All Principal Investigators ARE employed by the organization sponsoring the study. 
Results Point of Contact:
Organization: The University of Iowa Department of Radiology
phone: 3193563214
email: yusufmenda@uiowa.edu
Publications of Results:
Responsible Party:  Yusuf Menda, University of Iowa 
ClinicalTrials.gov Identifier:  NCT00721799 History of Changes 
Other Study ID Numbers: 
200801758 1R21CA130281 ( U.S. NIH Grant/Contract ) 
First Submitted:  June 10, 2008 
First Posted:  July 24, 2008 
Results First Submitted:  March 29, 2017 
Results First Posted:  October 3, 2017 
Last Update Posted:  October 3, 2017 