Trial Outcomes & Findings for F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients (NCT NCT00721799)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

33 participants

Primary outcome timeframe

36 months

Results posted on

2019-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	FLT PET Subjects who receive F-18 Fluorothymidine \[FLT\]PET imaging prior to treatment. F-18 Fluorothymidine: FLT PET scan \[0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)\]
Overall Study STARTED	33
Overall Study Recieved FLT PET Scan 1	26
Overall Study Received FLT PET Scan #2	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	FLT PET Subjects who receive F-18 Fluorothymidine \[FLT\]PET imaging prior to treatment. F-18 Fluorothymidine: FLT PET scan \[0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)\]
Overall Study Withdrawal by Subject	7
Overall Study withdraw by subject after scan 1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLT PET n=26 Participants Subjects who receive F-18 Fluorothymidine \[FLT\]PET imaging prior to treatment. F-18 Fluorothymidine: FLT PET scan \[0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)\]
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	57.8 years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)	4.23 standardized uptake value (SUV) Standard Deviation 1.46

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)	6.36 standardized uptake value (SUV) Standard Deviation 2.21

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)	47.86 mm^3 (cubic milimeters) Standard Deviation 32.49

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)	0.07 mL/g/min Standard Deviation 0.03

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)	0.04 l/min Standard Deviation 0.02

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)	143.68 standardized uptake value (SUV) Standard Deviation 96.18

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)	2.53 standardized uptake value (SUV) Standard Deviation 1.15

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)	3.85 standardized uptake value (SUV) Standard Deviation 1.80

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)	0.04 mL/g/min Standard Deviation 0.02

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)	0.02 l/min Standard Deviation 0.02

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)	101.26 standardized uptake value (SUV) Standard Deviation 76.91

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)	-0.39 percentage change in SUVmean Standard Deviation 0.18

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)	-0.39 percentage change in SUVmax Standard Deviation 0.20

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)	-0.33 percentage change in K-FLT Standard Deviation 0.21

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)	-0.51 percentage change in K-Patlak Standard Deviation 0.24

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)	-0.34 percentage change Standard Deviation 0.14

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)	4.23 standardized uptake value (SUV) Standard Deviation 1.46

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)	6.36 standardized uptake value (SUV) Standard Deviation 2.21

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)	47.86 mm^3 (cubic milimeters) Standard Deviation 32.49

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)	0.07 mL/g/min Standard Deviation 0.03

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)	0.4 l/min Standard Deviation 0.2

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the pre-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=27 Participants 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
Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)	143.68 standardized uptake value (SUV) Standard Deviation 96.18

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)	2.53 standardized uptake value (SUV) Standard Deviation 1.15

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)	3.85 standardized uptake value (SUV) Standard Deviation 1.80

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).	0.04 mL/g/min Standard Deviation 0.02

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)	0.02 l/min Standard Deviation 0.02

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent the mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)	101.26 standardized uptake value (SUV) Standard Deviation 76.91

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)	-0.39 percentage change in SUVmean Standard Deviation 0.18

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)	-0.39 percentage change in SUVmax Standard Deviation 0.20

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)	-0.33 percentage change in K-FLT Standard Deviation 0.21

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)	-0.51 percentage change in K-Patlak Standard Deviation 0.24

PRIMARY outcome

Timeframe: 36 months

Population: Participants who underwent both the pre-therapy and mid-therapy FLT PET scan

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.

Outcome measures

Outcome measures
Measure	FLT PET Scan n=25 Participants 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
Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)	-0.34 percentage change Standard Deviation 0.14

Adverse Events

FLT PET

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yusuf Menda, MD

The University of Iowa Department of Radiology

Phone: 319-356-3214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place