68Ga-FAPI-46 PET/CT to detect small bowel fibrostenosis in Crohn's disease
Official title: Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study Designed to Illuminate the Spectrum of Fibrostenosis in Patients With Small Bowel Crohn's Disease
Run by Mayo Clinic · NCT07273188 · Data updated 2026-11-12
This study will try whether a PET tracer called 68Ga‑FAPI‑46 can find early or developing fibrosis and strictures in the small bowel of adults with Crohn's disease.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | January 26, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT07273188 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with known small bowel Crohn's disease, a clinical or research CT/MR enterography within three months, and willingness to undergo 68Ga‑FAPI‑46 PET/CT and provide informed consent are ideal candidates.
✕Probably not a fit
Pregnant or breastfeeding people, those with hypersensitivity to the tracer excipients, and patients without small bowel involvement or with disease not driven by fibrostenosis are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective case‑control imaging study at the Mayo Clinic using the PET radiotracer 68Ga‑FAPI‑46 to image small bowel segments in adults with Crohn's disease. Participants are assigned to case or control groups based on recent CT or MR enterography showing a probable or definite stricture versus no stricture. All enrolled subjects undergo 68Ga‑FAPI‑46 PET/CT to see whether areas of early fibroblast activation and developing fibrosis show tracer uptake. The goal is to determine whether FAPI PET can identify pre‑stricture fibrostenotic changes that are not yet obvious on standard cross‑sectional imaging.
Why it matters
Potential benefit: If successful, this imaging approach could reveal early fibrostenosis before fixed strictures form, helping clinicians choose earlier medical or surgical strategies to prevent obstruction.
How similar studies have gone: Early FAPI PET studies have shown promising uptake in fibrotic tissues in other organs, but application specifically to small‑bowel Crohn's fibrostenosis is novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Known small bowel Crohn's disease * Research or clinical MR enterography, or clinical CT enterography, within 3 months. * Male or female with age greater than 18 years old. * Diagnosis of Crohn's disease by a gastroenterologist * Willingness to undergo 68Ga-FAPI-46 PET/CT * Subjects with the capacity to give informed consent and willingness to provide written consent Exclusion Criteria: * Pregnant and/or breast-feeding subjects. * Hypersensitivity to any excipients in 68Ga-FAPI-46
Where it's running
-
Mayo Clinic
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: David J Bartlett — Mayo Clinic
- Study coordinator: Brian Will
- Email: will.brian@mayo.edu
- Phone: 507-266-0111
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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.