RecruitingEarly Phase 1NCT07273188

68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease

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


Sponsor

Mayo Clinic

Enrollment

45 participants

Start Date

Jan 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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). Participants with small bowel Crohn's disease will be assigned to either a case or control group based on CT or MR enterography findings at enrollment. Cases will include participants who have a small bowel stricture or probable stricture, with or without penetrating complications. Controls will include participants with small bowel Crohn's disease without strictures. Controls may have active inflammatory disease, luminal narrowing, or no active inflammation (including postoperative or chronic changes), as long as no stricture is present. Because most radiologic strictures represent more advanced fibrostenosis, the study aims to enroll a larger proportion of controls to better characterize early fibrotic changes. Approximately one-third to one-half of participants will be cases, and the remainder controls. This design will allow comparison of FAPI uptake patterns in patients with and without strictures to understand how FAP expression relates to the development of small bowel fibrosis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special PET scan called 68Ga-FAPI-46 PET/CT to see whether it can better identify areas of scarring (fibrostenosis) in the small bowel of patients with Crohn's disease, compared to standard MRI or CT imaging. Scarring can cause bowel blockages and may require surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Crohn's disease affecting the small bowel - You have had an MRI enterography or CT enterography within the past 3 months - You are willing to undergo the PET/CT scan **You may NOT be eligible if...** - You do not have Crohn's disease in the small bowel - You are pregnant or breastfeeding - You have had recent bowel surgery that makes scanning results difficult to interpret - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGa68-FAPI-46

Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV


Locations(1)

Mayo Clinic

Rochester, Minnesota, United States

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NCT07273188


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