Pragmatic Study on the Use of 68Ga-PSMA-617 PET/CT Imaging as a Standard of Care to Influence Clinical Management of Tumors Overexpressing PSMA

What this Trial Is About

Researchers are evaluating the safety and clinical usefulness of cyclotron-produced 68Ga-PSMA-617 PET imaging in cancers that express PSMA, including prostate cancers and many other solid tumors. This open-label, non-randomized study aims to gather information on how this imaging method impacts patient management compared to current standard care. The study also seeks to promote routine use of this PET imaging in clinical settings for eligible cancer patients. Participants will receive an intravenous injection of 68Ga-PSMA-617, with the dose adjusted based on patient weight and PET scanner characteristics, up to a maximum of 370 MBq. About 60 to 90 minutes after the injection, they will undergo PET/CT scanning to capture images of their tumors. These images will be reviewed by a nuclear medicine physician. The study will monitor safety, including any side effects, and assess the accuracy of the imaging by identifying false positives or negatives and unusual tracer distribution. During the study, participants will be involved in the injection and imaging procedures, followed by monitoring for adverse events and analysis of imaging results. Researchers will collect data on how the imaging influences cancer staging, treatment decisions, and follow-up care. The main outcome measured is the incidence of treatment-emergent adverse events over five years. Additional outcomes include evaluating the impact on patient management and encouraging the adoption of 68Ga-PSMA-617 PET/CT as a standard diagnostic tool.

68Ga-PSMA-617 PET/CT for PSMA-expressing Tumor: a Pragmatic Study