68Ga-FAPI46 PET/CT for chronic inflammatory and fibrotic diseases
Official title: 68Gallium-FAPI46 PET/CT Imaging in Chronic Inflammatory and Fibrotic Diseases
Run by University Hospital, Brest · NCT06275477 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 390 (estimated) |
| Sponsor | University Hospital, Brest Academic / other |
| Locations | 1 site (Brest) |
| Status | Recruiting |
| Started | March 13, 2025 |
| Main results expected | October 5, 2028 |
| Study ends | October 5, 2028 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT06275477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Multimodal Eye Data Bank to Explore Inflammation-Related Eye Diseases
This observational effort collects rich eye-imaging data from people with inflammatory and retinal conditions to see how the front and back of the eye relate and to build a standardized database that could support future AI tools.
-
Clinical features, treatments, and outcomes in inflammation-associated non-rapidly-progressive coronary artery disease
This study will see how current treatments, inflammation markers, and patient characteristics relate to outcomes in people with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).
-
Treatment with Subcutaneous Infliximab for Crohn's Disease
This study is testing if a new way of giving infliximab can help people with moderate to severe Crohn's disease feel better without needing steroids.
-
Investigating characteristics of a special type of coronary artery disease
This study is trying to understand the unique features of a fast-progressing type of coronary artery disease by comparing patients with this condition to those with a more common form of the disease.
-
Evaluating comprehensive treatment for rapidly-progressive coronary artery disease
This study is testing a new treatment plan for people with rapidly-progressive coronary artery disease that includes medication and procedures to see if it helps them feel better and manage their condition.
-
Using advanced MRI to understand how Filgotinib relieves pain in rheumatoid arthritis
This study is testing how Filgotinib helps relieve pain in people with rheumatoid arthritis by looking at brain activity and inflammation.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.