Phase 2 Study of 68GaBED003 PET Imaging for Detecting Fibroblast Activation Protein in Colorectal, Gastric, Pancreatic, Breast, and Ovarian Cancers

What This Trial Is About

Researchers are evaluating the diagnostic performance of 68GaBED003 in detecting several types of cancer, including colorectal cancer, gastric cancer, pancreatic ductal adenocarcinoma, invasive lobular breast cancer, and epithelial ovarian cancer. This multi-centre, open-label, single-arm Phase 2 study aims to understand how well this PET imaging agent works in identifying these cancers. Participants receive an injection of 68GaBED003 followed by positron emission tomography PET combined with computed tomography CT imaging during a dedicated visit. The study monitors the diagnostic accuracy of the imaging, assesses tumor uptake of the agent, and evaluates safety and tolerability up to 42 days after injection. The first six participants also help determine optimal imaging timing and dosing. During the study, participants undergo screening, imaging, and safety follow-up, including pregnancy testing for women of childbearing potential. Researchers collect imaging data and monitor for any adverse effects up to 48 hours after injection and continue follow-up assessments for up to 42 days. Overall participation lasts from screening through safety follow-up and post-imaging observation.

[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications