AI-driven Narrow-band Imaging Score for Disease Assessment and Outcome Prediction in Ulcerative Colitis

Last updated: November 28, 2024
Sponsor: University College Cork
Overall Status: Active - Recruiting

Phase

N/A

Condition

Crohn's Disease

Inflammatory Bowel Disease

Treatment

Intestinal biopsies

Stool

Clinical follow-up

Clinical Study ID

NCT06709209
APC193
  • Ages 18-75
  • All Genders

Study Summary

This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients aged 18 to 75 years old

  • Established diagnosis of UC (for at least six months in duration), independentlyfrom their active treatment

  • Undergoing endoscopy for disease activity assessment or cancer surveillance.

Exclusion

Exclusion Criteria:

  • Contraindications to endoscopy (including toxic megacolon) and biopsies (includingsevere coagulopathy/thrombocytopenia)

  • Poor bowel preparation (defined as total BBPS <6 or BBPS <2 in observed segment forsigmoidoscopy)

  • Significant co-morbidities limiting life expectancy and conferring high risk ofendoscopy

  • Pregnant and breast-feeding subjects

  • Inability to provide informed consent

  • If the participant has been in a recent experimental trial, these must have beencompleted not less than thirty days prior to this study

Study Design

Total Participants: 300
Treatment Group(s): 5
Primary Treatment: Intestinal biopsies
Phase:
Study Start date:
November 04, 2024
Estimated Completion Date:
September 30, 2027

Study Description

This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes.

The study will be divided in several phases:

  • In the first phase, the score will be developed on the first 30 consecutive virtual electronic chromoendoscopy (VCE) videos (using TXI-RDI and NBI) of UC patients, with different grade of disease activity. Experts in inflammatory bowel disease (IBD) endoscopy will review images and videos from recruited patients to define the endoscopic mucosal and vascular features of the new score. These will be used for a stepwise discussion. A round table discussion using modified Delphi method will be conducted by experts worldwide to ensure equal participation and identify the best component descriptors of endoscopic vascular healing. The components that will achieve 100% consensus will be selected, and the most important endoscopy predictive variables will be confirmed by using a machine learning technique. Finally, a new endoscopic score will be generated. This should be reproducible, valid and responsive.

  • In the second phase, the new endoscopic scoring system will be validated in a large cohort of UC patients, focusing on patients with quiescent disease versus patchy mild colitis. Diagnostic accuracy, interobserver agreement and ability to predict clinical outcome according to the new endoscopic score focused on vascular features assessed with VCE will be evaluated

  • In the third phase, the reproducibility of the new endoscopic scoring system will be evaluated among gastroenterologists with different levels of experience through a short survey and a computerised training module.

  • In the fourth phase, new and existing AI algorithms will be developed and adapted to these endoscopic videos and histological images to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcome in UC.

Connect with a study center

  • University of Leuven

    Leuven,
    Belgium

    Site Not Available

  • Klinikum Luneburg

    Luneburg,
    Germany

    Site Not Available

  • University College Cork

    Cork, Co Cork
    Ireland

    Active - Recruiting

  • Ospedale S. Maria del Prato

    Feltre, Belluno
    Italy

    Site Not Available

  • University of Bari

    Bari,
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Milan,
    Italy

    Site Not Available

  • University Vita-Salute San Raffaele

    Milan,
    Italy

    Site Not Available

  • University of Naples

    Naples,
    Italy

    Active - Recruiting

  • University of Pavia

    Pavia,
    Italy

    Site Not Available

  • Showa University

    Tokyo,
    Japan

    Site Not Available

  • Changi General Hospital

    Singapore,
    Singapore

    Site Not Available

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