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Trial record 45 of 2060 for:    Oral Cancer | NIH

F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yusuf Menda, University of Iowa

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: 18F-Fluorothymidine 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.

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

Reporting Groups
  Description
FLT PET

Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.

F-18 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 F-18 Fluorothymidine [FLT]PET imaging prior to treatment.

F-18 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 Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of Mean Pre-therapy 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 Pre-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 Pre-therapy 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
C-statistic [5] 0.73
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



2.  Primary:   Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of Maximum Pre-therapy 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 Pre-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 Pre-therapy 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
C-statistic [5] 0.75
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



3.  Primary:   Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Pre-therapy 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 C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of Pre-therapy 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 Pre-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 Pre-therapy 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Primary:   Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of FLT Flux (K-FLT) Pre-therapy 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 (K-FLT) Pre-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 (K-FLT) Pre-therapy 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
C-statistic [5] 0.52
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



5.  Primary:   Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy 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 (K-Patlak) Pre-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 (K-Patlak) Pre-therapy 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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 non-inferiority 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 p-value 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 Progression Free Survival (PFS)
Groups [1] FLT PET Scan
Statistical Test Type [2] Other
Statistical Method [3] Regression, Cox
P Value [4] 0.05
C-statistic [5] 0.70
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



7.  Primary:   Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Mean Mid-therapy 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 Mid-therapy 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 non-inferiority 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 p-value 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 Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



8.  Primary:   Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Maximum Mid-therapy 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 Mid-therapy 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 non-inferiority 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 p-value 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 Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



9.  Primary:   Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of FLT Flux (K-FLT) Mid-therapy 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 (K-FLT) Mid-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 (K-FLT) Mid-therapy 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
C-statistic [5] 0.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



10.  Primary:   Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy 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 (K-Patlak) Mid-therapy 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 (K-Patlak) Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



11.  Primary:   Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Mid-therapy 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 Mid-therapy 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 non-inferiority 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 p-value 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 Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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 non-inferiority 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 p-value 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 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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 non-inferiority 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 p-value 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 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



14.  Primary:   Efficacy of Percent Change in FLT Flux (K-FLT) 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 (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) 
[Units: Percentage change in K-FLT]
Mean (Standard Deviation)
 -0.33  (0.21) 


Statistical Analysis 1 for Efficacy of Percent Change in FLT Flux (K-FLT) 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 non-inferiority 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 p-value 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 (K-FLT) 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



15.  Primary:   Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) 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 (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) 
[Units: Percentage change in K-Patlak]
Mean (Standard Deviation)
 -0.51  (0.24) 


Statistical Analysis 1 for Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) 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 non-inferiority 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 p-value 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 (K-Patlak) 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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 non-inferiority 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 p-value 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



17.  Primary:   Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of Mean Pre-therapy 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 Pre-therapy 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 non-inferiority 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 p-value 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 Pre-therapy 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 non-inferiority 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 p-value 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 Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of Maximum Pre-therapy 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 Pre-therapy 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 non-inferiority 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 p-value 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 Pre-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Pre-therapy 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 C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of Pre-therapy 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 Pre-therapy 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 non-inferiority 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 p-value 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 Pre-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 (K-FLT) Pre-therapy in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 K-FLT, 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS) 
[Units: mL/g/min]
Mean (Standard Deviation)
 0.07  (0.03) 


Statistical Analysis 1 for Efficacy of FLT Flux (K-FLT) Pre-therapy 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 non-inferiority 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 p-value 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 (K-FLT) Pre-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   27 
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy 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 (K-Patlak) Pre-therapy 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 non-inferiority 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 p-value 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 (K-Patlak) Pre-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 C-statistic (C-stat). 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 pre-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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 non-inferiority 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 p-value 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
C-statistic [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 non-inferiority 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 p-value 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 Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Mean Mid-therapy 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 Mid-therapy 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 non-inferiority 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 p-value 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 Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Maximum Mid-therapy 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 Mid-therapy 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 non-inferiority 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 p-value 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 Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 (K-FLT) Mid-therapy in Predicting Overall Survival (OS).   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat).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 K-FLT, 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS). 
[Units: mL/g/min]
Mean (Standard Deviation)
 0.04  (0.02) 


Statistical Analysis 1 for Efficacy of FLT Flux (K-FLT) Mid-therapy 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 non-inferiority 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 p-value 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 (K-FLT) Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy 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 (K-Patlak) Mid-therapy 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 non-inferiority 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 p-value 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 (K-Patlak) Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Mid-therapy 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 Mid-therapy 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 non-inferiority 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 p-value 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 Mid-therapy 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
C-statistic [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 non-inferiority 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 p-value 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 C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 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
C-statistic [5] 0.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 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
C-statistic [5] 0.59
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



30.  Primary:   Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

Measure Type Primary
Measure Title Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS) 
[Units: Percentage change in K-FLT]
Mean (Standard Deviation)
 -0.33  (0.21) 


Statistical Analysis 1 for Efficacy of Percent Change in FLT Flux (K-FLT) 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 (K-FLT) 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
C-statistic [5] 0.52
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



31.  Primary:   Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) 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 (K-Patlak) in Predicting Overall Survival (OS)
Measure Description Prediction efficacy is estimated using a hazard ratio (HR) and C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   25 
Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS) 
[Units: Percentage change in K-Patlak]
Mean (Standard Deviation)
 -0.51  (0.24) 


Statistical Analysis 1 for Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) 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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 (K-Patlak) 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
C-statistic [5] 0.56
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



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 C-statistic (C-stat). 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 pre-therapy and mid-therapy FLT PET scan

Reporting Groups
  Description
FLT PET Scan

Subjects receive 2 18F-Fluorothymidine PET scans

  • Scan 1 at baseline (within 30 days prior to the start of chemotherapy and radiation therapy)
  • Scan 2 between fraction 5 and 6 of radiation therapy (after 10 Gray of radiation)

F-18 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   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:
  No text entered.
[2] Details of power calculation, definition of non-inferiority 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 p-value 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 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
C-statistic [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 non-inferiority 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 p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.




  Serious Adverse Events


  Other Adverse Events


  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
  • HPV (human papilloma virus) status of tumors not available.
  • Therapy heterogeneity in the therapy; radiotherapy fairly consistent but chemotherapy regimens varied.
  • Small sample size is limiting.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Yusuf Menda, MD
Organization: The University of Iowa Department of Radiology
phone: 319-356-3214
e-mail: yusuf-menda@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