F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
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.
Head and Neck Neoplasms
Drug: F-18 Fluorothymidine
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||F-18 Fluorothymidine (FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)|
- Evaluate detection rate of primary and metastatic head & neck cancer sites with FLT PET imaging [ Time Frame: within the first month (+/- 5 days) ] [ Designated as safety issue: No ]
- Determine the efficacy of FLT PET imaging and change in FLT uptake for predicting outcome of treatment in terms of locoregional control and disease free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||June 2016|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: FLT PET
Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.
Drug: F-18 Fluorothymidine
FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721799
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Yusuf Menda, M.D.||The University of Iowa|
|Principal Investigator:||John M. Buatti, M.D.||The University of Iowa|