NCT06503146RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \[18F\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \[18F\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body. Objective: To see if \[18F\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers. Eligibility: People aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer. Design: Participants will have 2 baseline scans: an \[18F\]FAPI-74, and the approved tracer \[18F\]-FDG. The \[18F\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging. Within 1 week, participants will undergo the same scanning procedures with the approved tracer. If the baseline scan with \[18F\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \[18F\]FAPI-74 scan. If \[18F\]-FAPi PET scan shows no tumor(s), scans will not be repeated. If the participant's cancer progresses within 2 years, scans may be repeated. Follow-up calls will continue for 2 years.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 320 (estimated)
- First submitted
- 12 Jul 2024
- Start date
- 9 Sept 2025
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Mesothelioma, Neuroendocrine tumours, Bladder cancer, Lung cancer, Pancreatic cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer, Sarcoma
- NCT number
- NCT06503146
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 320
- From 9 Sept 2025 to the primary completion date, 1 Jun 2028
- 1 site 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.
Other illness
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to \[18F\]FAPI-74 or other agents used in the study.
- History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes.
- Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant.
Lab values
- Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
- Serum creatinine \> 2 times the upper limit of normal.
- Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.
Other
- Weight \> 350 lbs., or inability to fit within the imaging gantry.
Criteria the registry did not label
- INCLUSION CRITERIA:
- Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma.
- Participants must be scheduled or intended to receive treatment for their cancer.
- Evaluable disease
- \>= 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance score \<= 2.
- Individuals of child-bearing potential (IOCBP) and individuals that can father children must agree to use effective contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) at the study entry and for 2 months after each (18F) FAPI-74 imaging. Sperm may not be frozen or donated within the same period.
- Must be willing to discontinue breastfeeding for 2 months after each study imaging.
- The ability of participant to understand and the willingness to sign a written informed consent document.
Age in the registry: 18 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.