This phase IV trial studies a total-body positron emission tomography (PET)/computed tomography (CT) scan, EXPLORER, using different radiotracers for the imaging of prostate cancer and neuroendocrine tumors. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, such as 18F-PSMA, 68Ga-PSMA, 18F-FDG, 64Cu-DOTATATE, and 68Ga-DOTATATE. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient’s body. EXPLORER is the world's first total-body PET/CT scanner. The EXPLORER produces dynamic PET images. Dynamic PET imaging produces four-dimensional images collected over time. It is designed to capture the internal movement of organs and the metabolism of the tumor. It creates the most complete and accurate information on the tumor and provides information how the tumor moves with breathing and other body motions. Using different radiotracers such as, 18F-PSMA, 68Ga-PSMA, 18F-FDG, 64Cu-DOTATATE, and 68Ga-DOTATATE, with the total-body EXPLORER PET/CT scan may be useful for the imaging of prostate cancer and neuroendocrine tumors.
Additional locations may be listed on ClinicalTrials.gov for NCT05160480.
Locations matching your search criteria
United States
California
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Lorenzo Nardo
Phone: 916-816-1614
PRIMARY OBJECTIVE:
I. To acquire preliminary data regarding radiotracer avidity, i.e. standardized uptake value measurements (standardized uptake value [SUV] maximum [max] and mean) of tumor and normal tissue as a function of time with fluorine F 18 piflufolastat (18F-PSMA) (or gallium Ga 68 gozetotide [68Ga-PSMA]), fludeoxyglucose F 18 (18F-FDG), and copper Cu 64 dotatate (64Cu-DOTATATE) or gallium Ga 68-dotatate (68Ga-DOTATATE) in a total-body PET scanner among men with suspected prostate cancer metastasis, and patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors.
SECONDARY OBJECTIVE:
I. To acquire dynamic PET emission data of radiotracer distribution and estimate tumor radiotracer kinetics (ki), with 18F-PSMA (or 68Ga-PSMA), 18F-FDG, and 64Cu-DOTATATE (or 68Ga-DOTATATE) in a total-body PET among men with suspected prostate cancer metastasis and patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors.
II. To acquire dynamic PET emission data of radiotracer distribution and estimate tumor radiotracer kinetics (ki) when men with suspected prostate cancer metastasis are injected with different tracers: 18F-FDG; 64Cu-DOTATATE/68Ga-DOTATATE; and 18F-PSMA/68Ga-PSMA.
EXPLORATORY OBJECTIVE:
I. To acquire dynamic PET emission data of radiotracer distribution and estimate organ radiotracer kinetics (ki), with 18F-FDG, 18F-PSMA or 68Ga-PSMA, 64Cu-DOTATATE/68Ga-DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis and patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors.
OUTLINE: Patients are assigned to 1 of 3 groups.
GROUP I: Patients undergo ultra-low dose CT scan and then receive either 18F-PSMA or 68Ga-PSMA intravenously (IV) and undergo dynamic PET scan over up to 90 minutes. Patients also undergo ultra-low dose CT scan followed by static PET scan over 20-30 minutes at 3- and 6- hours post-radiotracer injection.
GROUP II: Patients undergo ultra-low dose CT scan and then receive either 64Cu-DOTATATE or 68Ga-DOTATATE IV and undergo dynamic PET scan over up to 90 minutes. Patients also undergo ultra-low dose CT scan followed by static PET scan over 20-30 minutes at 3- and 6- hours post-radiotracer injection.
GROUP III: Patients undergo ultra-low dose CT scan, receive 18F-FDG IV, and undergo dynamic PET scan over up to 90 minutes during the first visit. During the second visit, patients undergo ultra-low dose CT scan and receive either 18F-PSMA or 68Ga-PSMA IV, or 64Cu-DOTATATE or 68Ga-DOTATATE IV and undergo dynamic PET scan over up to 90 minutes. During the third visit, patients undergo ultra-low dose CT scan, receive 18F-PSMA or 68Ga-PSMA IV if they received a DOTATATE intervention at visit 2, or 64Cu-DOTATATE or 68Ga-DOTATATE IV if they received a PSMA intervention at visit 2, and undergo dynamic PET scan over up to 90 minutes. At the fourth visit, patients undergo ultra-low dose CT scan, receive either 18F-PSMA or 68Ga-PSMA IV, or 64Cu-DOTATATE or 68Ga-DOTATATE IV and undergo dynamic PET scan over up to 90 minutes.
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorLorenzo Nardo
