Recruiting
Early Phase 1

68Ga-FAPI-46

Sponsor:

Mayo Clinic

Code:

NCT07273188

Conditions

Crohn's Disease

Intestinal Fibrosis

Inflamatory Bowel Disease

Intestinal Strictures Related to Crohn´s Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ga68-FAPI-46

Study Details

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 ID

NCT07273188

Start date

Jan 26, 2026

Status verified date

Feb, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

Ga68-FAPI-46 radioactive tracer binding to FAP

Interventions

Ga68-FAPI-46

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

Primary outcome measure

  • Completion of PET/CT with Ga68-FAPI-46 by all participants [ Time Frame: Through study completion, an average of 2 years ]
  • Number of participants completing PET/CT with Ga68-FAPI-46 [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.