Imaging Intestinal Fibrosis with 68Ga-FAPi PETCT in Adults with Crohns Disease or Ulcerative Colitis

What this Trial Is About

Researchers are evaluating the use of 68Ga-FAPi PETCT imaging to detect intestinal fibrosis in patients with inflammatory bowel disease IBD, including Crohns disease and ulcerative colitis. The study aims to link 68Ga-FAPi uptake with cellular FAP expression found in intestinal biopsies and resection specimens. This phase 2 trial focuses on assessing how well this imaging technique identifies fibrotic areas in the intestines of affected patients. Participants will undergo a 68Ga-FAPi-46 PET-CT scan as the experimental diagnostic test. The study includes adults diagnosed with either Crohns disease or ulcerative colitis who show signs of active disease through clinical symptoms, blood or stool markers, or imaging tests. The trial will monitor tracer uptake and analyze pharmacokinetics, aiming to optimize the protocol and determine the minimal effective tracer dose. During the study, participants will be evaluated from baseline up to 12 weeks after enrollment. Researchers will detect areas with increased 68Ga-FAPi uptake, perform visual and semi-quantitative assessments of tracer behavior, and optimize imaging procedures. The study measures focus on identifying fibrotic regions and improving imaging accuracy, with careful monitoring of safety and study progress throughout the participation period.

FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients