Actively Recruiting
Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPI-46) PET in Crohn's Disease Patients: a Case-control Study to Illuminate Fibrostenosis in Small Bowel Crohn's Disease
Led by Mayo Clinic · Updated on 2026-02-09
45
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel. This early phase 1 case-control study aims to understand if early or developing fibrosis areas take up the tracer, which binds to fibroblast activation protein (FAP). Participants with small bowel Crohn's disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PET/CT scan using the radioactive tracer Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46), administered intravenously at a dose of 5 mCi ±10%. Cases include participants with small bowel strictures or probable strictures, while controls include those without strictures but may have other disease features. This design allows researchers to investigate different stages of fibrosis development in Crohn's disease. During the study, participants will complete the PET/CT scan with 68Ga-FAPI-46. Researchers will monitor the completion rates of these scans over an average of 2 years. Participants will be evaluated through imaging and clinical assessments related to their Crohn's disease status. Safety, tracer uptake patterns, and disease characteristics will be documented throughout the study period.
CONDITIONS
Brief Title
68Ga-FAPI-46 PET/CT for Assessing Small Bowel Fibrostenosis in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Known small bowel Crohn's disease
- Research or clinical MR enterography, or clinical CT enterography, within 3 months
- Male or female aged over 18 years
- Diagnosis of Crohn's disease by a gastroenterologist
- Willingness to undergo 68Ga-FAPI-46 PET/CT
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Pregnant and/or breast-feeding
- Hypersensitivity to any excipients in 68Ga-FAPI-46
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single visit
Participants undergo a PET/CT scan with 68Ga-FAPI-46 to assess small bowel fibrostenosis in Crohn's disease.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
B
Brian Will
Y
Yong S Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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