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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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)

Brief Summary:

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.

Detailed Summary:
Sponsor: University of Iowa

Current Primary Outcome: Evaluate detection rate of primary and metastatic head & neck cancer sites with FLT PET imaging [ Time Frame: within the first month (+/- 5 days) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: University of Iowa

Dates:
Date Received: June 10, 2008
Date Started: February 2008
Date Completion: June 2020
Last Updated: February 9, 2017
Last Verified: February 2017