F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients
Status:
Completed
Trial end date:
2014-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Iowa
Collaborators:
National Cancer Institute (NCI) National Institutes of Health (NIH)