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COMPLETED
NCT05641896
PHASE2

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

Sponsor: SOFIE

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2023-04-28

Completion Date

2025-06-30

Last Updated

2026-10-01

Healthy Volunteers

No

Interventions

DRUG

[18F]FAPI-74 PET/CT

\[18F\]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastrointestinal cancers.

Locations (6)

University of California Los Angeles (UCLA) Health

Los Angeles, California, United States

Massachusetts general hospital

Boston, Massachusetts, United States

BAMF Health

Grand Rapids, Michigan, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Northwell Health

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, United States