AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls

NCT07546955 | Not Yet Recruiting

• 1 other identifier: REB 19656
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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will receive intravenous fluorescein, and the imaging system will record fluorescence in the colon as the scope is withdrawn.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.

Conditions

NON-IBD; Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)

Keywords

IBD, CD, UC; Non-IBD

Outcome Measures

Primary Outcomes (2)

• • Feasibility of Procedure

  • Feasibility of Procedure: The proportion of enrolled patients in whom the full fluorescence mapping procedure is successfully completed as intended. This will include metrics such as ability to intubate the colon and obtain fluorescence images from cecum to rectum; any significant technical difficulties encountered (and their nature); additional procedure time added by the imaging (in minutes); and whether the resulting fluorescence data was of analyzable quality. We will define success as achieving a usable permeability map of the colon surface. Feasibility will also be described by qualitative feedback from endoscopists on workflow integration.

  From enrollment to end of study = one patient visit

• • Safety of the Imaging System

  Incidence and severity of adverse events related to the investigational aspects (fluorescein and AI system). This includes any allergic reactions to fluorescein, any hemodynamic instability during the procedure attributable to the dye, any complications from prolonged procedure time (e.g. hypoxia from sedation), or any device malfunctions leading to patient risk. Adverse events will be categorized as mild, moderate, severe, and their relationship to the study intervention will be adjudicated. The primary safety endpoint is the absence of any Serious Adverse Effect. We hypothesize that the rate of serious complications will be \<5%, with the expectation of 0% severe allergic reactions in a 60 patient sample (based on fluorescein's known \<1/1000 severe reaction rate). We will specifically report the number of patients with any fluorescein-related reaction (and details if so).

  From enrollment to end of study = one patient visit

Secondary Outcomes (5)

• • Correlation with Endoscopic Severity:

  From enrollment to end of study = one patient visit

• • Correlation with Histopathology

  From enrollment to end of study = one patient visit

• • Correlation with Ussing ex vivo permeability (Performed at McMaster only)

  From enrollment to end of study = one patient visit

• • Accuracy of AI Detection

  From enrollment to end of study = one patient visit

• • Inter-Observer Consistency

  From enrollment to end of study = one patient visit

Study Arms (2)

IBD

Adult patients with established inflammatory bowel disease (ulcerative colitis or Crohn's disease involving the colon) who are undergoing colonoscopy for clinical reasons, will be invited to participate. We will include patients across the spectrum of disease activity (remission to active inflammation) to capture a broad range of mucosal permeability patterns. Approximately 60 IBD participants will be enrolled at the three sites, representing both major IBD subtypes and varying disease distribution

Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping

Non-IBD

An additional 10 non-IBD controls undergoing routine CRC screening or surveillance will be included.

Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping

Interventions

Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping DIAGNOSTIC_TEST

This is an observational study, and participants are not assigned a therapeutic intervention as part of the research. All participants will undergo a clinically indicated colonoscopy as part of routine care. As part of the study procedures, colonoscopy will be supplemented with intravenous sodium fluorescein, wide-field fluorescence imaging during scope withdrawal, and AI-assisted video recording and analysis to assess mucosal permeability. In addition, targeted research biopsies will be collected from selected colonic regions for histologic assessment, and at the McMaster site a subset of biopsies will also undergo ex vivo Ussing chamber permeability testing.

IBD; Non-IBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

They will be patients of the Investigator and co-investigators. When the patient comes in for their usual clinical care and/or disease monitoring, the doctor will approach his or her own patients. If the patient is willing to learn more about the research project and provides consent to learn more, the doctor will introduce the patient to the study coordinator.

You may qualify if:

• 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
• Ability to comply with study procedures

You may not qualify if:

• Allergy to fluorescein
• Colorectal cancer
• Advanced polyps or malignant lesions identified during colonoscopy
• Significant cardiopulmonary disease
• Renal failure
• Active infection or sepsis
• Severe IBD flare
• Use of medications that may affect gut permeability, including NSAIDs or antibiotics
• Inability to tolerate bowel preparation or safely complete the protocol
• Pregnancy or breastfeeding
• Inability or unwillingness to provide informed consent or comply with study procedures

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonic mucosal biopsies obtained from high- and low-fluorescence regions (3 per high/low region; 6 total per participant) will be formalin-fixed, and paraffin-embedded. Research-specific histologic processing, staining, and scoring will be performed by the research team using research resources.To further validate the biological meaning of the fluorescence signal, permeability findings obtained in vivo will also be compared with ex vivo ⁵¹Cr-EDTA flux measured in Ussing chambers, which serves as a well-established physiological benchmark of epithelial barrier function.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Premysl Bercik, MD

  Hamilton Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liam Rondeau, PhD

CONTACT

905-521-2100; rondeaul@mcmaster.ca

Melanie AM Wolfe, MLA-T,CCRP

CONTACT

905-521-2100; wolfe@hhsc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share