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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA130281 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This is an imaging protocol only, not a therapeutic study.
The primary goal of the proposed study is to examine the utility of a new imaging study, Positron Emission Tomography with F-18 Fluorothymidine (FLT PET), in the early treatment evaluation of head and neck cancer. FLT uptake in the tumor correlates with the rate of cell proliferation. It is therefore hoped that changes in tumor FLT uptake after therapy will reflect change in the number of actively dividing tumor cells and will provide early assessment of treatment response.
Research subjects will undergo one PET scan with FLT. The scan is done prior to any therapeutic intervention (radiation or chemotherapy) can be obtained up to 30 days prior to the start of therapy. The uptake of FLT in the tumor will be analyzed to see if it can be used as a predictor of treatment efficacy and/or outcome.
There is an optional biopsy component to this study. Should the attending physicians (primarily the otolaryngologists) believe that the subject can safely undergo an outpatient biopsy, and the subject agrees, a biopsy is performed. The biopsy will be done within 30 days prior to treatment, similar to FLT PET scans. Tissue from the biopsy will be analyzed for markers of cellular proliferation and these markers will be correlated with the findings of FLT PET scan.
There will be a 2-year clinical follow-up to assess for treatment outcomes, local control, and overall survival.
There are approximately 40,000 new cases of head and neck cancer each year in the United States. Approximately two thirds of these patients present with locally advanced disease with either large disease at the primary site and/or spread to regional lymph node levels. Treatment options include surgery, radiotherapy, and chemotherapy, usually applied in combination for advanced disease. Despite aggressive treatment, the 5-year survival for locally advanced disease remains poor (overall, approximately 50%). To increase the efficacy of locoregional therapy, different treatment maneuvers are used including increased radiation dose, concurrent use of chemotherapy and radiation therapy and high dose intra-arterial chemotherapy. Unfortunately, the increased intensity of combined treatment also leads to greater treatment related morbidity and mortality. It is currently difficult to predict who will benefit from intensive chemoradiotherapy and who would be most effectively treated with other combinations such as surgery and postoperative radiotherapy.
It is predictable that the most immediate signal of a successful antitumor therapeutic regime will be a decrease in cellular proliferation in the tumor. Therefore, a tracer, which is taken up into and retained in cells as a function of their proliferative activity, should provide rapid information as to the effectiveness of the treatment. FLT is an ideal tracer in this setting as its uptake is a function of thymidine kinase activity. Thymidine kinase activity is an established marker of cellular proliferation. FLT can be imaged with a PET scanner and the FLT uptake in the tumor can be reliably quantified. Preliminary studies including at our institution also confirm accumulation of FLT in untreated head and neck cancers. The objective of our study is to evaluate the utility of FLT PET imaging in predicting the outcome of treatment in terms of locoregional control and disease-free survival in patients (i.e., progression free survival) with head and neck cancer as well as overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLT PET scan | Experimental | Subjects receive 2 18F-Fluorothymidine PET scans
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Fluorothymidine PET scan | Drug | 18F-Fluorothymidine (0.04 - 0.08 mCi / kg to a maximum dose of 5 mCi) administered once intravenously for a positron emission tomography (PET) scan. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yusuf Menda, M.D. | University of Iowa | Principal Investigator |
| John M. Buatti, M.D. | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19525472 | Result | Menda Y, Boles Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Kinetic analysis of 3'-deoxy-3'-(18)F-fluorothymidine ((18)F-FLT) in head and neck cancer patients before and early after initiation of chemoradiation therapy. J Nucl Med. 2009 Jul;50(7):1028-35. doi: 10.2967/jnumed.108.058495. Epub 2009 Jun 12. | |
| 20447554 | Result | Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005. |
| Label | URL |
|---|---|
| The Holden Comprehensive Cancer Center | View source |
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Data will be shared through clinicaltrials.gov and in provision with the filed data sharing plan for the grant. Consent was not obtained from participants to share individual patient data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%)] |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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%)] |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
|
1 calendar day following injection with the tracer agent, FLT
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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%)] |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yusuf Menda, MD | The University of Iowa Department of Radiology | 319-356-3214 | yusuf-menda@uiowa.edu |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 36 months |
| Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | 36 months |
| Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS). | 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. | 36 months |
| Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS) | 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. | 36 months |
| Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS) | 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. | 36 months |
| 20439512 | Result | Juweid ME, Thomas D, Menda Y, Tewson T, Graham MM, Herrmann K, Buck AK, Fayad L. PET/CT with 18F-FLT is unlikely to cause significant hepatorenal or hematologic toxicity. J Nucl Med. 2010 May;51(5):824-5. doi: 10.2967/jnumed.110.075945. No abstract available. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | mm^3 (cubic milimeters) | 36 months |
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| Primary | Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | mL/g/min | 36 months |
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| Primary | Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | l/min | 36 months |
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| Primary | Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | mL/g/min | 36 months |
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| Primary | Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | l/min | 36 months |
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| Primary | Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in SUVmean | 36 months |
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| Primary | Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in SUVmax | 36 months |
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| Primary | Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in K-FLT | 36 months |
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| Primary | Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in K-Patlak | 36 months |
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| Primary | Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change | 36 months |
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| Primary | Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | mm^3 (cubic milimeters) | 36 months |
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| Primary | Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | mL/g/min | 36 months |
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| Primary | Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | l/min | 36 months |
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| Primary | Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS) | 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. | Participants who underwent the pre-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS). | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | mL/g/min | 36 months |
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| Primary | Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | l/min | 36 months |
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| Primary | Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS) | 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. | Participants who underwent the mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | standardized uptake value (SUV) | 36 months |
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| Primary | Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in SUVmean | 36 months |
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| Primary | Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in SUVmax | 36 months |
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| Primary | Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in K-FLT | 36 months |
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| Primary | Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change in K-Patlak | 36 months |
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| Primary | Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS) | 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. | Participants who underwent both the pre-therapy and mid-therapy FLT PET scan | Posted | Mean | Standard Deviation | percentage change | 36 months |
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|
|
|
| 6 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
Not provided
Not provided
Not provided
| D010610 |
| Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| 0.75 |
| 2-Sided |
| Other |
| 0.74 |
| 2-Sided |
| Other |
| 0.52 |
| 2-Sided |
| Other |
| 0.45 |
| 2-Sided |
| Other |
| 0.70 |
| 2-Sided |
| Other |
| 0.58 |
| 2-Sided |
| Other |
| 0.60 |
| 2-Sided |
| Other |
| 0.59 |
| 2-Sided |
| Other |
| 0.47 |
| 2-Sided |
| Other |
| 0.69 |
| 2-Sided |
| Other |
| 0.63 |
| 2-Sided |
| Other |
| 0.62 |
| 2-Sided |
| Other |
| 0.48 |
| 2-Sided |
| Other |
| 0.54 |
| 2-Sided |
| Other |
| 0.64 |
| 2-Sided |
| Other |
| 0.72 |
| 2-Sided |
| Other |
| 0.74 |
| 2-Sided |
| Other |
| 0.82 |
| 2-Sided |
| Other |
| 0.48 |
| 2-Sided |
| Other |
| 0.45 |
| 2-Sided |
| Other |
| 0.74 |
| 2-Sided |
| Other |
| 0.61 |
| 2-Sided |
| Other |
| 0.63 |
| 2-Sided |
| Other |
| 0.71 |
| 2-Sided |
| Other |
| 0.48 |
| 2-Sided |
| Other |
| 0.74 |
| 2-Sided |
| Other |
| 0.59 |
| 2-Sided |
| Other |
| 0.59 |
| 2-Sided |
| Other |
| 0.52 |
| 2-Sided |
| Other |
| 0.56 |
| 2-Sided |
| Other |
| 0.63 |
| 2-Sided |
| Other |