Actively Recruiting

Phase 2
Age: 18Years - 120Years
All Genders
NCT06503146

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Led by National Cancer Institute (NCI) · Updated on 2026-05-04

320

Participants Needed

1

Research Sites

246 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection

Who Can Participate

Age: 18Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed diagnosis of pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma, small cell lung cancer, extrapulmonary neuroendocrine cancer, mesothelioma, or sarcoma
  • Scheduled or intended to receive treatment for cancer
  • Presence of evaluable disease
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance score 2 or less
  • Individuals of child-bearing potential and individuals who can father children must agree to use effective contraception at study entry and for 2 months after each [18F] FAPI-74 imaging
  • Willing to discontinue breastfeeding for 2 months after each study imaging
  • Ability to understand and willingness to sign written informed consent
Not Eligible

You will not qualify if you...

  • History of allergic reactions to compounds similar to [18F]FAPI-74 or other agents used in the study
  • Severe claustrophobia not relieved by oral anxiolytics or any condition preventing lying still in the imaging scanner for up to 45 minutes
  • Weight over 350 pounds or inability to fit in the imaging scanner
  • Positive pregnancy test in individuals of child-bearing potential at screening
  • Uncontrolled illness or medical conditions such as renal failure, liver failure, or psychiatric illness/social situations that limit compliance or increase risk
  • Serum creatinine levels more than twice the upper limit of normal
  • Liver transaminases (ALT, AST) greater than three times the upper limit of normal

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

Y

Yolanda L McKinney, R.N.

CONTACT

E

Esther Mena Gonzalez, M.D.

CONTACT

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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