Actively Recruiting
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Led by National Cancer Institute (NCI) · Updated on 2026-05-19
320
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new PET imaging tracer called [18F]FAPI-74 to detect cancer by targeting the fibroblast-activation protein (FAP) found in cancer-associated fibroblasts. This study aims to compare [18F]FAPI-74 PET scans to the standard [18F]-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytoma/paraganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute (NCI). Participants will receive an intravenous dose of [18F]FAPI-74 before undergoing PET/CT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by [18F]FAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline [18F]FAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.
CONDITIONS
Brief Title
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma, small cell lung cancer or extrapulmonary neuroendocrine cancer, mesothelioma or sarcoma.
- Scheduled or intended to receive treatment for cancer.
- Evaluable disease present.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance score of 2 or less.
- Individuals able to use effective contraception or agree to abstain from breastfeeding for 2 months after each imaging.
- Willingness and ability to sign informed consent.
You will not qualify if you...
- History of allergic reactions to compounds similar to [18F]FAPI-74 or other study agents.
- Severe claustrophobia not relieved by medication or any condition preventing lying still for up to 45 minutes during imaging.
- Weight over 350 lbs or inability to fit into the imaging scanner.
- Positive pregnancy test in individuals of child-bearing potential.
- Uncontrolled illnesses or medical conditions that may limit study compliance or increase risk.
- Serum creatinine level exceeding twice the upper normal limit.
- Liver enzymes (ALT, AST) greater than three times the upper normal limit.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo baseline [18F]FAPI-74 and 18F-FDG PET imaging to detect sites of cancer.
1 visit (in-person)
Duration - 2 years
Participants are followed for 2 years after the first [18F]FAPI-74 PET scan to assess progression-free and overall survival, with additional PET imaging if suspicion for recurrence or disease progression arises.
Follow-up visits as needed for additional PET imaging
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
Y
Yolanda L McKinney, R.N.
E
Esther Mena Gonzalez, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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