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

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.

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Key information

Conditions

Gastrointestinal Cancers Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatocellular Carcinoma Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Ductal Adenocarcinoma Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California Los Angeles (UCLA) Health, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
No treatment received between tissue sample taken and [18F]FAPI-74 PET
Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
Age ≥ 18 years
Completed informed consent as determined per the IRB of record

Exclusion criteria

Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
Need for emergent surgery that would be delayed by participation
Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee
Patients receiving any other investigational agent within the past 28 days
Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FAPI-74 injection
Known hypersensitivity to any excipients used in [18F]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
Renal or liver function impairment* *Defined by liver impairments as AST>3x the upper limit of normal, ALT>3x the upper limit of normal, or bilirubin>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of >1.5x the upper limit of normal utilizing the Cockcroft Gault formula

Treatment and study plan

[18F]FAPI-74 PET/CT

Drug

[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.

Primary outcomes

Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for FAP analysis.

Time frame: Through study completion, 2 years

Lesions positive for FAP as detected by immunohistochemistry and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging

Secondary outcomes

Positive predictive value will be determined on a per-lesion basis for all lesions with tissue available for histopathology.

Time frame: Through study completion, 2 years

Malignant lesions as detected by histopathology and Lesions positive for FAP as detected by [18F]FAPI-74 PET imaging
Further characterize the safety profile of [18F]FAPI-74 in subjects utilizing Common Terminology Criteria for Adverse Events (CTCAE v5)

Time frame: Through study completion, 2 years

Incidence and severity of treatment emergent adverse events occurring within 24 hours.

Sponsors and collaborators

Lead sponsor

SOFIE

Industry

Registry information

Official study title

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

Acronym: 18F-FAPI-74 GI

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 8, 2022
Registry last updated: Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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