68Ga-FAPI46 PET/CT for chronic inflammatory and fibrotic diseases
68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases
We will try a new PET/CT scan using 68Ga-FAPI46 to see if it helps detect and monitor chronic inflammatory and fibrotic conditions in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Trial ID | NCT06275477 on ClinicalTrials.gov |
What this trial studies
This single-center pilot uses 68Ga-FAPI46 PET/CT, a radiotracer that binds fibroblast activation protein, to image a range of chronic inflammatory and fibrosing conditions. Thirteen clinical situations—including rheumatoid arthritis, liver fibrosis, and systemic lupus—are included to explore where the tracer may add diagnostic or monitoring value. Participants who meet consensus diagnostic criteria will receive the PET/CT and imaging findings will be compared with existing clinical and imaging information to characterize tracer uptake patterns. The project aims to identify promising applications for further development and to refine how this imaging could be integrated into routine care.
Who should consider this trial
Good fit: Adults (18+) with one of the specified chronic inflammatory or fibrotic conditions who meet consensus diagnostic and clinical criteria, can give informed consent, are not pregnant or breastfeeding, and have local social security coverage are ideal candidates.
Not a fit: Patients with active cancer, pregnant or breastfeeding women, those unable to consent, or people whose condition is not among the 13 selected clinical situations are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the scan could improve detection and monitoring of activated fibroblast activity, enabling earlier or more targeted treatment decisions for patients with inflammatory or fibrotic diseases.
How similar studies have performed: 68Ga-FAPI tracers have shown promising diagnostic performance compared with 18F-FDG in oncology, but evidence in non-oncologic inflammatory and fibrotic diseases is limited and remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 18 or over. * Affected by one of the pathologies concerned by the study (see Table 4) * Satisfying the consensus classification criteria for the pathology (Table 3). * Satisfying the corresponding clinical situation (Table 3). * Negative urine pregnancy test for women of childbearing age. * Affiliated with or benefiting from social security. * Informed consent (personally dated and) signed by the participant or any representatives (impartial witness/trusted person). Exclusion Criteria: * Patients unable to consent. * Incapacitated adults. * Pregnant or breastfeeding women. * Patients refusing to participate in research. * Known active cancer. * Women of childbearing potential unwilling to use appropriate contraception (definitions given in Annex 1).
Where this trial is running
Brest
- Chu Brest — Brest, France (Recruiting)
Study contacts
- Study coordinator: Pierre-Yves LE ROUX, PHD
- Email: pierre-yves.leroux@chu-brest.fr
- Phone: +33 (0) 229020266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.