The National Cancer Institute (NCI) is recruiting people with mesothelioma and several other cancer types for a Phase 2 diagnostic imaging trial evaluating a new PET tracer.
The trial, designated NCT06503146, is enrolling at the NIH Clinical Center in Bethesda, Maryland.
About the Study
Background:
Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain tumor types. [18F]FAPI-74 is a new PET (positron emission tomography) tracer, a substance injected into the body before an imaging scan. Researchers believe [18F]FAPI-74 PET imaging may visualize tumors more effectively than currently approved tracers, making it easier to detect FAP-positive cancers.
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.
Treatment Approach
This is a diagnostic imaging study, not an immunotherapy trial. It compares a new PET tracer, [18F]FAPI-74, against the standard [18F]-FDG tracer for detecting tumors.
Key trial details:
- Phase: Phase 2
- Sponsor: National Cancer Institute (NCI)
- Intervention: [18F]FAPI-74 PET imaging (vs. [18F]-FDG PET)
- Status: Recruiting
Why This Trial Matters
This NCI-sponsored study evaluates a next-generation PET tracer that targets fibroblast-activation protein. More accurate tumor imaging could improve staging and treatment planning for people with mesothelioma and other cancers.
Study Locations
The trial is recruiting at:
- NIH Clinical Center, Bethesda, Maryland
How to Enroll
Patients interested in this trial should:
- Discuss eligibility with their oncologist
- Review the full eligibility criteria on ClinicalTrials.gov
- Contact the study coordinator for screening