NCT05641896CompletedPhase 2
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 29 Nov 2022
- Start date
- 28 Apr 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- SOFIE
- Diseases
- Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer, Gastric and esophageal cancer
- NCT number
- NCT05641896
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 112
- From 28 Apr 2023 to the primary completion date, 30 Jun 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Need for emergent surgery that would be delayed by participation
- Patients receiving any other investigational agent within the past 28 days
Other illness
- 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
Lab values
- 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
Other
- 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)
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| Northwell Health Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| University of California Los Angeles (UCLA) Health Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center Mskcc Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.