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

NCT ID: NCT07273188

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-04-30

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.

Conditions

Crohn's Disease; Intestinal Fibrosis; Inflamatory Bowel Disease; Intestinal Strictures Related to Crohn´s Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A group of participants getting PET/CT scan with 68Ga-FAPI-46

Ga68-FAPI-46 radioactive tracer binding to FAP

Group Type: EXPERIMENTAL

Ga68-FAPI-46

Intervention Type: DRUG

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

Interventions

Ga68-FAPI-46

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

David J. Bartlett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J Bartlett

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Central Contacts

Brian Will

Role: CONTACT

will.brian@mayo.edu

507-266-0111

Yong S Lee

Role: CONTACT

lee.yong@mayo.edu

507-538-4446

Other Identifiers

25-008885

Identifier Type: -

Identifier Source: org_study_id