TriangleNCT00721799 · STUDY IN CONTEXT
F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
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.
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.
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- trial label
- F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0000
- source section id
- NCT00721799-om-0000
- source outcome index
- 0
- endpoint
- Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)
- endpoint definition
- 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 origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who underwent the pre-therapy FLT PET scan
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0001
- source section id
- NCT00721799-om-0001
- source outcome index
- 1
- endpoint
- Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)
- endpoint definition
- 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 origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who underwent the pre-therapy FLT PET scan
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0002
- source section id
- NCT00721799-om-0002
- source outcome index
- 2
- endpoint
- Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)
- endpoint definition
- 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 origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who underwent the pre-therapy FLT PET scan
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0003
- source section id
- NCT00721799-om-0003
- source outcome index
- 3
- endpoint
- Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)
- endpoint definition
- 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 origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who underwent the pre-therapy FLT PET scan
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0004
- source section id
- NCT00721799-om-0004
- source outcome index
- 4
- endpoint
- Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)
- endpoint definition
- 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 origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who underwent the pre-therapy FLT PET scan
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0005
- source section id
- NCT00721799-om-0005
- source outcome index
- 5
- endpoint
- Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)
- endpoint definition
- 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 origin
- 36 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants who underwent the pre-therapy FLT PET scan
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0000
- arm key
- OG000
- arm label
- FLT PET Scan
- regimen
- 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
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00721799-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0001
- arm key
- OG000
- arm label
- FLT PET Scan
- regimen
- 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
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00721799-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0002
- arm key
- OG000
- arm label
- FLT PET Scan
- regimen
- 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
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00721799-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0003
- arm key
- OG000
- arm label
- FLT PET Scan
- regimen
- 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
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00721799-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0004
- arm key
- OG000
- arm label
- FLT PET Scan
- regimen
- 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
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00721799-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- outcome key
- om-0005
- arm key
- OG000
- arm label
- FLT PET Scan
- regimen
- 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
- analyzed count
- 27
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00721799-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-oropharyngeal-cancer
- nct id
- NCT00721799
- harm key
- EG000
- source section id
- NCT00721799-ae
- event group key
- EG000
- event group label
- FLT PET
- serious affected
- 0
- serious at risk
- 26
- other affected
- 0
- other at risk
- 26
- frequency threshold
- 2
- collection period
- 1 calendar day following injection with the tracer agent, FLT
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice