What is 68Ga-FAPI-46 studying for Crohn's disease?

68Ga-FAPI-46 is being studied to see if it can detect fibrostenosing changes in the small bowel of people with Crohn's disease. Researchers want to understand how this tracer binds to fibroblast activation protein in areas of early fibrosis. The Mayo Clinic is leading this research to improve detection of disease progression.

Who may be eligible for this Crohn's disease clinical trial?

Adults 18 years or older with a diagnosis of small bowel Crohn's disease by a gastroenterologist may be eligible. Participants must have had a recent MR or CT enterography within 3 months and be willing to undergo the PET/CT scan. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this Crohn's disease clinical trial?

Study-related care, including the PET/CT scan with the study tracer, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Early Phase 1

Age: 18Years +

All Genders

ID07273188

Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 68Ga-FAPI-46 PET in Crohns Disease Patients a Case-control Study to Illuminate Fibrostenosis in Small Bowel Crohns Disease

Led by Mayo Clinic · Updated on 2026-02-09

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohns 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 Crohns disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PETCT 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 Crohns disease. During the study, participants will complete the PETCT 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 Crohns 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

Age: 18Years +

All Genders

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

Research Team

Brian Will

Yong S Lee

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