Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Summary

Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of \[18F\]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The \[18F\]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.

Timeline

Start

2023-04-28

Primary completion

2025-06-30

Completion

2025-06-30

Outcome

Met primary endpoint

release “Favorable End-of-Phase 2 meeting with U.S. FDA for [ 18 F]FAPI-74 for GI cancers Primary and secondary endpoints met” sofie.com ↗

Drugs

Indications