NCI FAPI-74 PET Imaging Phase 2 Trial (NCT06503146)
National Cancer Institute Phase 2 imaging trial evaluating [18F]FAPI-74 PET scans for cancer detection, including mesothelioma (NCT06503146).
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
Reader Q&A
Frequently Asked Questions
Is mesothelioma one of the worst cancers?
Mesothelioma ranks among the deadliest cancers due to its low 5-year survival rate of 7.2-12% across stages, lower than most others except pancreatic cancer at 7.3%. Localized pleural mesothelioma, the most common type affecting over 75-80% of people with the disease, has a 20% 5-year survival rate, dropping to 8% for distant spread. Median life expectancy after diagnosis ranges from 12-21 months with treatment, often shorter without it, reflecting its aggressive nature linked to asbestos exposure. Factors like stage at diagnosis and treatment access influence individual outcomes.
What does asbestos look like on CT?
Asbestos exposure causes asbestosis, which on CT scans shows intralobular linear opacities (reticulation), centrilobular dot-like opacities from peribronchial fibrosis, and irregular opacities with a fine reticular pattern, especially in early stages confined to lower lung zones. Advanced asbestosis appears as excessive whiteness or honeycombing in lung tissue on chest X-rays, with CT providing greater detail for early detection. Asbestosis relates to mesothelioma risk in people with asbestos exposure, though CT findings alone cannot confirm asbestos presence without history or biopsy. Visual identification of asbestos fibers (white, blue, brown, or green in damaged materials) requires lab testing, as raw appearance does not predict content ,.
What is the life expectancy of asbestos patients in the lungs?
People with asbestos-related lung cancer have an average life expectancy of 16.2 months, similar to non-asbestos-related lung cancer at 17.2 months, with 25% achieving five-year survival after treatment. Life expectancy varies by type and stage: non-small cell lung cancer (NSCLC) ranges from 57 months in early stages to 5 months in stage 4, while small cell lung cancer (SCLC) averages 7-16 months overall. Without treatment, NSCLC survival averages just over 7 months and SCLC 2-4 months. Asbestosis, a non-cancerous lung scarring from asbestos, has an average life expectancy of about 10 years post-diagnosis, though many live longer. These figures depend on factors like stage, health, and treatment.
What lung cancer is caused by asbestos?
Asbestos exposure causes all major histological types of lung cancer, including adenocarcinoma, squamous cell carcinoma, and small-cell carcinoma. Studies link inhalation of asbestos fibers to increased lung cancer risk among exposed workers, with risk rising based on exposure dose and duration across all asbestos types. Estimates indicate 4-12% of lung cancers relate to occupational asbestos exposure, and 20-25% of heavily exposed workers develop bronchogenic carcinoma. Asbestos-related lung cancer typically develops at least a decade after first exposure and is histologically similar to lung cancer from other causes. Smoking combined with asbestos exposure multiplies lung cancer risk substantially.