About this trial
This pilot study will test a new imaging system that uses fluorescent dye and artificial intelligence (AI) during colonoscopy to measure how "leaky" the lining of the colon is in people with inflammatory bowel disease (IBD). The study will include 70 adults at 3 Canadian hospitals: 60 people with ulcerative colitis or Crohn's disease affecting the colon, and 10 people without IBD who are having colonoscopy for routine colorectal cancer screening or surveillance. During the colonoscopy, participants will receive intravenous fluorescein, and the imaging system will record fluorescence in the colon as the scope is withdrawn. The main goal is to find out whether this method can be used safely during routine colonoscopy and whether it can produce usable measurements of mucosal permeability. The study will also examine whether these measurements are related to standard measures of inflammation seen during endoscopy, in biopsy samples, and in ex vivo Ussing chamber testing at the McMaster site. The control group will help define what normal fluorescence and permeability look like. This study is intended to provide early data on whether this approach could become a useful new way to assess barrier dysfunction in IBD.
Eligibility criteria
Qualifiers
Adults aged 18 years or older
Able to provide written informed consent
Established ulcerative colitis or Crohn's disease involving the colon, or non-IBD control undergoing screening/surveillance colonoscopy
Undergoing clinically indicated colonoscopy
Disqualifiers
Allergy to fluorescein
Colorectal cancer
Advanced polyps or malignant lesions identified during colonoscopy
Significant cardiopulmonary disease
Trial design
Treatments tested in this trial
- Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping
Treatment groups
Locations
Sponsors and collaborators
Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator