Crohn's Disease, Inflamatory Bowel Disease, Intestinal Fibrosis, Intestinal Strictures Related to Crohn´s Disease
Conditions
Keywords
Ga68-FAPI-46, PET/CT, Small bowel stricture, Fibrostenosis, FAPI PET, Small bowel Crohn's disease
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.
Interventions
DRUGGa68-FAPI-46
Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV
Sponsors
Mayo Clinic
The Leona M. and Harry B. Helmsley Charitable Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Through study completion, an average of 2 years | Participants complete PET/CT with Ga68-FAPI-46 |
Countries
United States
Contacts
CONTACTBrian Will
CONTACTYong S Lee
PRINCIPAL_INVESTIGATORDavid J Bartlett
Mayo Clinic
Outcome results
None listed