68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
Early Phase 1 · Testing Ga68-FAPI-46 · 1 site · Mayo Clinic
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Ga68-FAPI-46 (a drug) as a way to diagnose or measure disease. Condition(s) listed: Crohn's Disease, Intestinal Fibrosis and Inflamatory Bowel Disease.
It is open-label: participants know what they are receiving.
Early Phase 1 studies are very small first studies in people, mainly checking safety and how the body handles a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 45 participants are expected to take part.
- Start date: 2026-01-26.
- Main results expected around 2027-02-28 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Completion of PET/CT with Ga68-FAPI-46 by all participants (Through study completion, an average of 2 years)
In the researchers’ words
This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. The goal is to determine whether areas of early or developing fibrosis ("pre-stricture" changes) demonstrate uptake of the tracer, which binds to fibroblast activation protein (FAP).
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Early Phase 1 |
| Study type | Interventional |
| Conditions | Crohn's Disease; Intestinal Fibrosis; Inflamatory Bowel Disease; Intestinal Strictures Related to Crohn´s Disease |
| Lead sponsor | Mayo Clinic |
| Collaborators | The Leona M. and Harry B. Helmsley Charitable Trust |
| Enrollment | 45 (estimated) |
| Start date | 2026-01-26 |
| Primary completion (est.) | 2027-02-28 |
| First posted | 2025-12-09 |
| Last updated | 2026-02-09 |
| 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 |
| ClinicalTrials.gov ID | NCT07273188 |
Interventions
- Ga68-FAPI-46 (Drug)
Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic | Rochester, Minnesota | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.