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 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.

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

March 27 2026

Active Locations (1)

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Page 1 of 1 (1 locations)

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892