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RECRUITING

NCT06503146

PHASE2

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 120 Years

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2025-09-09

Completion Date

2030-06-01

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Sarcoma Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)Mesothelioma Pheochromocytoma/Paraganglioma (PPGL)Pancreatic Ductal Adenocarcinoma Ovarian Cancer Hepatocellular Carcinoma Gastric Cancer Cholangiocarcinoma Bladder Cancer

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.

* 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.

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States