DESCRIPTION (provided by applicant): This project will evaluate a non-invasive PET method for assessment of tumor perfusion using generator- produced copper-62. The proposed method will be suitable for implementation at any clinical PET center in the U.S., complementing current clinical whole-body PET 18F-FDG studies to assess tumor metabolism. The project's clinical focus is patients with head-and-neck cancer, where literature evidence indicates that tumor perfusion measurements can be predictive of response to therapy. Patients with localized or locally advanced head and neck cancer, who are to receive concurrent chemo-radiation therapy, will receive the investigational 62Cu-ETS radiopharmaceutical for "whole-body" PET/CT imaging to assess tumor perfusion. The 62Cu-ETS imaging will occur immediately prior to scheduled standard baseline and post-therapy clinical PET/CT with 18F-FDG. A subset of patients will also be imaged using 15O-water to provide an independent reference measure of tumor perfusion. The 62Cu-ETS tumor perfusion results will be quantified using an image-derived arterial input function. Global and regional measures of tumor perfusion will be compared to the findings from 18F- FDG imaging, as well as to changes in tumor size using RECIST criteria. Subjects will be seen for follow-up one month after completion of treatment;then a minimum of every three months. The imaging results will be examined for correlations with independent measures of clinical outcome, including twenty-four month actuarial local progression-free survival, regional progression-free survival, distant metastases-free survival and overall survival. Therapy failure will be defined as biopsy-proven recurrent disease, or imaging results inconsistent with any other explanation than disease recurrence or metastases. Planned neck dissection following chemo-radiotherapy showing the presence of residual viable tumor cells will not be classified as regional failure, as this will be considered completion of the planned curative therapy. The project both requires, and exploits, radiopharmaceutical production technologies under development by Proportional Technologies, Inc., and the expertise of academic collaborators from the Purdue University School of Pharmacy and the Indiana University School of Medicine. PUBLIC HEALTH RELEVANCE: Head and neck cancers account for about 3% of adult malignancies in the United States, and disproportionately affect African Americans. This project initiates clinical evaluation of a PET imaging method to evaluate tumor blood flow, using imaging technology that can be readily implemented at medical centers throughout the country. This PET method is expected to improve the physician's ability to make optimal treatment decisions for head and neck cancer patients.
|Effective start/end date||8/1/09 → 7/31/14|
- National Institutes of Health: $437,758.00
- National Institutes of Health: $416,149.00
- National Institutes of Health: $476,882.00
- National Institutes of Health: $420,747.00
Head and Neck Neoplasms
Outcome Assessment (Health Care)