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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
109
\[18F\]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.
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
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.
Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by \[18F\]FAPI-74 PET imaging
Time frame: Through study completion, 2 years
Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.
Malignant lesions as detected by histopathology and Lesions positive for FAP as detected by \[18F\]FAPI-74 PET imaging
Time frame: Through study completion, 2 years
Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)
Incidence and severity of treatment emergent adverse events occurring within 24 hours.
Time frame: Through study completion, 2 years
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