RecruitingPhase 2NCT06503146

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


Sponsor

National Cancer Institute (NCI)

Enrollment

320 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of PET scan imaging agent called [18F]FAPI-74 to detect and monitor several types of cancer. This scan targets a protein (fibroblast activation protein) that is highly expressed in many tumor types and could help doctors see cancer more clearly. **You may be eligible if...** - You are 18 or older - You have been confirmed by biopsy to have one of the following cancers: pancreatic ductal adenocarcinoma, cholangiocarcinoma (bile duct), hepatocellular carcinoma, gastric cancer, bladder cancer, ovarian cancer, certain rare tumors (pheochromocytoma/paraganglioma), small cell lung cancer, neuroendocrine cancer, mesothelioma, or sarcoma - You are scheduled or planning to receive treatment for your cancer - Your overall health is reasonable (ECOG score ≤ 2) - You are willing to use contraception during the study and for 2 months afterward **You may NOT be eligible if...** - You have a known allergy to compounds similar to [18F]FAPI-74 - You are claustrophobic and cannot lie in a PET scanner for up to 45 minutes - You weigh more than 350 lbs or cannot fit in the imaging machine - You are pregnant - You have significant kidney or liver failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]FAPI-74

Participants will receive a single intravenous (IV) dose of \[18F\]FAPI-74 prior to PET/CT imaging.

DRUG[18F]FDG

18F-FDG PET/CT or PET/MRI imaging will be done per standard of care.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06503146


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