Status:
RECRUITING
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
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 tomo...
Detailed Description
Background: * Fibroblast-activation protein (FAP) is a transmembrane type 2 serine protease with dipeptidyl peptidase and endopeptidase activity that is overexpressed on the surface of cancer-associa...
Eligibility Criteria
Inclusion
- 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.
- EXCLUSION CRITERIA:
- 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.
- Weight \> 350 lbs., or inability to fit within the imaging gantry.
- Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.
- 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.
- Serum creatinine \> 2 times the upper limit of normal.
- Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.
Exclusion
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06503146
Start Date
September 9 2025
End Date
June 1 2030
Last Update
November 12 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892