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

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ClinicalTrials.gov Identifier: NCT00721799
Recruitment Status : Active, not recruiting
First Posted : July 24, 2008
Results First Posted : October 3, 2017
Last Update Posted : September 28, 2018
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
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FLT PET
Hide Arm/Group Description

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%)]

Period Title: Overall Study
Started 33
Recieved FLT PET Scan 1 26
Received FLT PET Scan #2 25
Completed 25
Not Completed 8
Reason Not Completed
Withdrawal by Subject             7
withdraw by subject after scan 1             1
Arm/Group Title FLT PET
Hide Arm/Group Description

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%)]

Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  80.8%
>=65 years
5
  19.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants
57.8  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
2
   7.7%
Male
24
  92.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
19
  73.1%
Unknown or Not Reported
7
  26.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
4.23  (1.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.47
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.73
Estimation Comments [Not Specified]
2.Primary Outcome
Title Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
6.36  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.75
Estimation Comments [Not Specified]
3.Primary Outcome
Title Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mm^3 (cubic milimeters)
47.86  (32.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.44
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.74
Estimation Comments [Not Specified]
4.Primary Outcome
Title Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mL/g/min
0.07  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.52
Estimation Comments [Not Specified]
5.Primary Outcome
Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: l/min
0.04  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.45
Estimation Comments [Not Specified]
6.Primary Outcome
Title Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
143.68  (96.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.70
Estimation Comments [Not Specified]
7.Primary Outcome
Title Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
2.53  (1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.58
Estimation Comments [Not Specified]
8.Primary Outcome
Title Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
3.85  (1.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.60
Estimation Comments [Not Specified]
9.Primary Outcome
Title Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mL/g/min
0.04  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.59
Estimation Comments [Not Specified]
10.Primary Outcome
Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: l/min
0.02  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.47
Estimation Comments [Not Specified]
11.Primary Outcome
Title Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
101.26  (76.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.69
Estimation Comments [Not Specified]
12.Primary Outcome
Title Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in SUVmean
-0.39  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.63
Estimation Comments [Not Specified]
13.Primary Outcome
Title Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in SUVmax
-0.39  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.62
Estimation Comments [Not Specified]
14.Primary Outcome
Title Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in K-FLT
-0.33  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.00
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.48
Estimation Comments [Not Specified]
15.Primary Outcome
Title Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in K-Patlak
-0.51  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.30
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.54
Estimation Comments [Not Specified]
16.Primary Outcome
Title Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.34  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.64
Estimation Comments [Not Specified]
17.Primary Outcome
Title Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
4.23  (1.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Estimation Comments [Not Specified]
18.Primary Outcome
Title Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
6.36  (2.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.74
Estimation Comments [Not Specified]
19.Primary Outcome
Title Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mm^3 (cubic milimeters)
47.86  (32.49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 3.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.82
Estimation Comments [Not Specified]
20.Primary Outcome
Title Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: mL/g/min
0.07  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.48
Estimation Comments [Not Specified]
21.Primary Outcome
Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: l/min
0.4  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.45
Estimation Comments [Not Specified]
22.Primary Outcome
Title Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the pre-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
143.68  (96.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.99
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.74
Estimation Comments [Not Specified]
23.Primary Outcome
Title Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
2.53  (1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.61
Estimation Comments [Not Specified]
24.Primary Outcome
Title Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
3.85  (1.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.63
Estimation Comments [Not Specified]
25.Primary Outcome
Title Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mL/g/min
0.04  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.71
Estimation Comments [Not Specified]
26.Primary Outcome
Title Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: l/min
0.02  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.48
Estimation Comments [Not Specified]
27.Primary Outcome
Title Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent the mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: standardized uptake value (SUV)
101.26  (76.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.39
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.74
Estimation Comments [Not Specified]
28.Primary Outcome
Title Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in SUVmean
-0.39  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.59
Estimation Comments [Not Specified]
29.Primary Outcome
Title Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in SUVmax
-0.39  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.59
Estimation Comments [Not Specified]
30.Primary Outcome
Title Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in K-FLT
-0.33  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.52
Estimation Comments [Not Specified]
31.Primary Outcome
Title Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change in K-Patlak
-0.51  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.56
Estimation Comments [Not Specified]
32.Primary Outcome
Title Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who underwent both the pre-therapy and mid-therapy FLT PET scan
Arm/Group Title FLT PET Scan
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.34  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FLT PET Scan
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter C-statistic
Estimated Value 0.63
Estimation Comments [Not Specified]
Time Frame 1 calendar day following injection with the tracer agent, FLT
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FLT PET
Hide Arm/Group Description

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%)]

All-Cause Mortality
FLT PET
Affected / at Risk (%)
Total   6/26 (23.08%) 
Show Serious Adverse Events Hide Serious Adverse Events
FLT PET
Affected / at Risk (%)
Total   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
FLT PET
Affected / at Risk (%)
Total   0/26 (0.00%) 
  • 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.
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
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: September 28, 2018