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

NCT07273188 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 25-008885
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

Ga68-FAPI-46; PET/CT; Small bowel stricture; Fibrostenosis; FAPI PET; Small bowel Crohn's disease

Outcome Measures

Primary Outcomes (2)

• Completion of PET/CT with Ga68-FAPI-46 by all participants

  Through study completion, an average of 2 years

• Number of participants completing PET/CT with Ga68-FAPI-46

  Participants complete PET/CT with Ga68-FAPI-46

  Through study completion, an average of 2 years

Study Arms (1)

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

EXPERIMENTAL

Ga68-FAPI-46 radioactive tracer binding to FAP

Drug: Ga68-FAPI-46

Interventions

Ga68-FAPI-46 DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant and/or breast-feeding subjects.
• Hypersensitivity to any excipients in 68Ga-FAPI-46

Sponsors & Collaborators

• Mayo Clinic: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• David J Bartlett

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Will

CONTACT

507-266-0111; will.brian@mayo.edu

Yong S Lee

CONTACT

507-538-4446; lee.yong@mayo.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 9, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)