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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant and/or breast-feeding subjects.

Hypersensitivity to any excipients in 68Ga-FAPI-46

Trial design

Design model

Single group

Treatments tested in this trial

  • Ga68-FAPI-46

    Drug

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

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: A group of participants getting PET/CT scan with 68Ga-FAPI-46Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, an average of 2 years
2

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

Participants complete PET/CT with Ga68-FAPI-46

Time frame
Through study completion, an average of 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator