NCI 8701: A Pilot Study Utilizing C11 Alpha Methyl Tryptophan (AMT) PET Functional Imaging in Patients With Metastatic Invasive Breast Cancer Treated With 1 Methyl D Tryptophan Plus the Ad p53 DC Vaccine
Coordinating Center: Southeast Phase 2 Consortium (SEP2C), Moffitt Cancer Center.
Research participation involves up to three experimental imaging examination visits in
radiology: a baseline before the patient starts a cancer treatment, a follow-up a few days
later, and a later follow up to see how the treatment may affect normal or abnormal
processing of Tryptophan.
The research imaging results will be linked with other evidence of the patient's disease,
but will not effect their care.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Occurrence of Detected Changes in Regions of Interest (ROIs)
Changes in C-11 AMT uptake and localization (measured by SUV) between baseline and approximately 4 days after initiation of treatment. The primary objective is to determine whether such changes can be detected in regions of interest (ROIs) using PET/CT imaging in patients with metastatic breast cancer enrolled in NCI 8461/ MCC16025. The SUV values in identified regions of interest (ROIs) for each patient will be compared over time between baseline and approximately 4 days after initiation of treatment, and after completion of the protocol treatment. The analysis will be largely exploratory and descriptive as the sample size and study design will likely preclude an adequate/definitive statistical conclusion of SUV values between the two time points.
Average of 7 weeks
Hatem Soliman, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
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