Pragmatic Study on the Use of 68Ga-DOTA-TATE PET/CT Imaging as a Standard of Care to Influence Clinical Management in Neuroendocrine Tumors

What this Trial Is About

Researchers are evaluating the safety profile of the PET radiotracer 68Ga-DOTA-TATE to support its use as a routine standard-of-care diagnostic tool for patients with neuroendocrine tumors (NET). This pragmatic clinical trial is prospective, non-randomized, and open-label, conducted at a single center with recruitment across Canada. Previous studies have shown that 68Ga-DOTA-TATE is superior to the former standard-of-care imaging method, Octreoscan, and this trial aims to collect further data to support its adoption for NET patients. Participants referred by their physicians who meet eligibility criteria will receive an intravenous injection of 68Ga-DOTA-TATE at a dose of 3 MBq/kg, up to a maximum of 370 MBq. After waiting 45 to 90 minutes, patients will undergo imaging using a PET/CT scanner. The images will be reviewed by trained nuclear medicine physicians. The study will monitor the safety profile of the radiotracer, including any adverse effects, false positives or negatives, and abnormal biodistribution. During the study, participants will be assessed for safety outcomes over five years, including monitoring for any side effects and the clinical impact of imaging on patient management. Data collected will help establish 68Ga-DOTA-TATE as a routine diagnostic tool for NET. The study will track safety and clinical outcomes to support this implementation while ensuring ongoing observation and care for participants throughout the study period.

68Ga-DOTA-TATE PET/CT Imaging in NETs