Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
Bruce L Will
CONTACT
Bruce S Lee, Ph.D.
CONTACT
NCT Number: NCT07273188
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Bruce L Will
CONTACT
Bruce S Lee, Ph.D.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Gallium-68-labeled fibroblast activation protein inhibitor-46 (68Ga-FAPI-46) , 5 mCi ±10%, IV
Time frame: Through study completion, an average of 2 years
Time frame: Through study completion, an average of 2 years
Participants complete PET/CT with Ga68-FAPI-46
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
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
Acronym: FAPI-PETCD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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