AI-based imaging score for assessing ulcerative colitis

A Novel Simplified Endoscopic Score aiMed at Evaluating Ulcerative cOlitis Activity Through TXI, RDI and NBI Vascular Assessment and at prEdicting Clinical Outcome and Its Applicability in an arTificial Intelligence System: the MONET Study

This study is testing a new scoring system using advanced imaging techniques to see if it can better assess the condition of the colon in people with ulcerative colitis compared to current methods.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University College Cork (other)
• Locations: 11 sites (Leuven and 10 other locations)
• Trial ID: NCT06709209 on ClinicalTrials.gov

What this trial studies

This international multicentre study aims to create a new scoring system using advanced endoscopic techniques to evaluate the vascular features of the colon in patients with ulcerative colitis (UC). The study will develop this score by analyzing virtual electronic chromoendoscopy videos and comparing its effectiveness in determining disease activity and remission against existing scores. Additionally, it will adapt artificial intelligence algorithms to enhance the standardization of disease assessment and predict long-term outcomes for UC patients. The study will involve expert reviews and discussions to refine the scoring criteria.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with a confirmed diagnosis of ulcerative colitis who are undergoing endoscopy for disease assessment.

Not a fit: Patients with contraindications to endoscopy or significant comorbidities that limit life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of ulcerative colitis, improving patient management and outcomes.

How similar studies have performed: Other studies have shown promise in using advanced imaging techniques and AI for disease assessment, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* Adult patients aged 18 to 75 years old
* Established diagnosis of UC (for at least six months in duration), independently from their active treatment
* Undergoing endoscopy for disease activity assessment or cancer surveillance.

Exclusion Criteria:

* Contraindications to endoscopy (including toxic megacolon) and biopsies (including severe coagulopathy/thrombocytopenia)
* Poor bowel preparation (defined as total BBPS \<6 or BBPS \<2 in observed segment for sigmoidoscopy)
* Significant co-morbidities limiting life expectancy and conferring high risk of endoscopy
* Pregnant and breast-feeding subjects
* Inability to provide informed consent
* If the participant has been in a recent experimental trial, these must have been completed not less than thirty days prior to this study

Where this trial is running

Leuven and 10 other locations

• University of Leuven — Leuven, Belgium (NOT_YET_RECRUITING)
• Klinikum Luneburg — Lüneburg, Germany (NOT_YET_RECRUITING)
• University College Cork — Cork, Co Cork, Ireland (RECRUITING)
• Ospedale S. Maria del Prato — Feltre, Belluno, Italy (NOT_YET_RECRUITING)
• University of Bari — Bari, Italy (NOT_YET_RECRUITING)
• Istituto Clinico Humanitas — Milan, Italy (NOT_YET_RECRUITING)
• University Vita-Salute San Raffaele — Milan, Italy (NOT_YET_RECRUITING)
• University of Naples — Naples, Italy (RECRUITING)
• University of Pavia — Pavia, Italy (NOT_YET_RECRUITING)
• Showa University — Tokyo, Japan (NOT_YET_RECRUITING)
• Changi General Hospital — Singapore, Singapore (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Marietta Iacucci, MD — University College Cork
• Study coordinator: Michelle O'Riordan

Conditions: Ulcerative Colitis, Virtual Chromoendoscopy, Artificial Intelligence, Disease Assessment, Outcome Prediction