68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ga68-FAPI-46.
- Who it may be relevant to
- Registry conditions: Crohn's Disease, Intestinal Fibrosis, Inflamatory Bowel Disease, Intestinal Strictures Related to Crohn´s Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study Designed to Illuminate the Spectrum of Fibrostenosis in Patients With Small Bowel Crohn's Disease
Overview
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
- Drug Ga68-FAPI-46
Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT07273188 · 25-008885