Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Observational Model: Cohort, Time Perspective: Prospective
Response of primary tumor to treatment after six weeks, based on each of 1. change in PET uptake from baseline 2. change in CT tumor size from baseline 3. PET EORTC response criteria 4. CT RECIST response criteria
We expect a 60-70% response rate to treatment. 20 subjects will provide 95% power at 5% error to detect a difference in SUV level between groups as small as two standard deviations.
Sanjiv Sam Gambhir M.D., Ph.D.
United States: Food and Drug Administration
|Stanford University School of Medicine||Stanford, California 94305-5317|