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

Mayo Clinic

Status and phase: Not yet enrolling; Early Phase 1

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

Treatments: Drug: Ga68-FAPI-46

Study type: Interventional

Funder types: Other

Identifiers

NCT07273188

25-008885

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

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

Experimental group

Description:

Ga68-FAPI-46 radioactive tracer binding to FAP

Treatment:

Drug: Ga68-FAPI-46