Study of a New EpCAM-Targeted PET Radiotracer for Imaging Epithelial Tumors to Detect and Stage Cancer

What this Trial Is About

Researchers are studying the imaging performance and safety of an EpCAM-targeted radiotracer called 68GaGa-PN-EpC1 in patients with epithelial tumors. The study aims to determine how well this PETCT imaging tracer detects EpCAM-positive tumor lesions, how tracer uptake relates to EpCAM levels in tumor tissue, and whether the radiotracer is safe and well tolerated. Participants will receive a single intravenous dose of the 68GaGa-PN-EpC1 radiotracer at 0.05-0.1 mCikg, followed by whole-body PETCT imaging according to the study protocol. Some participants may have additional dynamic or delayed imaging. The imaging is done prior to tumor biopsy or surgical removal, and findings will be compared with tissue analysis and standard imaging. During the study, participants will undergo PETCT scans and then have tumor biopsies or surgery within two months for histopathological confirmation. Safety is monitored by tracking any adverse events up to 72 hours after radiotracer injection. The main measure is the sensitivity of the PETCT in detecting lesions, with secondary measures including specificity, accuracy, correlation with EpCAM expression, and overall safety. This trial runs until December 2028.

Evaluation of an EpCAM-Targeted Radiotracer in Epithelial Tumors