NCT07273188 68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
| NCT ID | NCT07273188 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-01-26 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2026-01-26 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
David J Bartlett
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07273188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07273188 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07273188 currently recruiting?
Yes, NCT07273188 is actively recruiting participants. Contact the research team at will.brian@mayo.edu for enrollment information.
Where is the NCT07273188 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT07273188 clinical trial?
NCT07273188 is sponsored by Mayo Clinic. The principal investigator is David J Bartlett at Mayo Clinic. The trial plans to enroll 45 participants.
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