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Sponsors and Collaborators: |
University of Iowa National Institutes of Health (NIH) National Cancer Institute (NCI) |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00721799 |
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 two PET scans with FLT. The first 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 second FLT scan is done after the 5th radiation therapy session (before the 6th treatment). The change in uptake of FLT in the tumor between two PET scans 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, two biopsies are performed. Biopsies will be done within 30 days prior to treatment and after the 5th radiation therapy treatment and before the 6th 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 scans.
There will be a 2-year clinical follow-up to assess for treatment outcomes, local control, and overall survival.
Condition | Intervention | Phase |
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Mouth Neoplasms Oropharyngeal Neoplasms Laryngeal Neoplasms Head and Neck Neoplasms |
Drug: F-18 Fluorothymidine |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
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) |
Estimated Enrollment: | 50 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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FLT PET: Experimental
Subjects who receive FLT PET imaging prior to treatment and after 5 radiation treatments
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Drug: F-18 Fluorothymidine
FLT PET scan 5 mCi (+/- 10%)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yusuf Menda, M.D. | (319) 356-3214 | yusuf-menda@uiowa.edu |
Contact: Jane Hershberger, RN, BSN | (319) 384-7912 | jane-hershberger@uiowa.edu |
United States, Iowa | |
University of Iowa Hospitals and Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Jane Hershberger, RN, BSN 319-384-7912 jane-hershberger@uiowa.edu |
Principal Investigator: | Yusuf Menda, M.D. | The University of Iowa |
Principal Investigator: | John M. Buatti, M.D. | The University of Iowa |
Principal Investigator: | Timothy Tewson, Ph.D. | The University of Iowa |
Responsible Party: | Department of Radiology-Nuclear Medicine ( Yusuf Menda, M.D. ) |
Study ID Numbers: | 200801758, 1R21CA130281 |
Study First Received: | June 10, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00721799 |
Health Authority: | United States: Food and Drug Administration |
Positron-Emission Tomography |
Mouth Diseases Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Squamous cell carcinoma Pharyngeal Neoplasms Laryngeal Neoplasms Pharyngeal Diseases Mouth Neoplasms Carcinoma Epidermoid carcinoma |
Respiratory Tract Diseases Oral cancer Head and Neck Neoplasms Carcinoma, squamous cell Laryngeal carcinoma Laryngeal Diseases Stomatognathic Diseases Carcinoma, Squamous Cell Carcinoma, squamous cell of head and neck Oropharyngeal Neoplasms |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |