Clinical trial Recruiting at 1 site Observational

AI-powered multimodal imaging for diagnosing and predicting digestive disease outcomes

Official title: AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases

Run by First Affiliated Hospital, Sun Yat-Sen University · NCT07087418 · Data updated 2026-11-12

This project will test an AI tool that combines CT and MR enterography with endoscopy data to help diagnose and predict outcomes for people with Crohn's disease, ulcerative colitis, intestinal tuberculosis, or Behçet's disease.

Quick facts

Study typeObservational
SexAll
Enrollment5000 (estimated)
SponsorFirst Affiliated Hospital, Sun Yat-Sen University
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedAugust 1, 2026
Study endsAugust 1, 2026
Registry record updatedApril 13, 2026
Trial IDNCT07087418 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people with clinically, endoscopically, and pathologically confirmed Crohn's disease, ulcerative colitis, intestinal tuberculosis, or Behçet's disease who have high-quality CT or MR enterography plus a high-quality colonoscopy within one month of imaging.

Probably not a fit

Patients without adequate imaging quality, poor bowel preparation or incomplete colonoscopy, or with conditions outside the targeted digestive diseases are unlikely to benefit from the model.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program combines retrospective and prospective imaging, endoscopic, and clinical data to build an AI system that integrates multimodal images (MRE and CTE) for diagnosis and prognostication of digestive diseases. Investigators retrospectively collected data from 21 centers across China to train and iteratively optimize the model, and will prospectively validate performance at two centers. The workflow includes real-world deployment in endoscopy suites to verify lesion localization using a virtual endoscopy model-assisted approach. Eligible cases require multimodal-confirmed diagnoses and at least one technically adequate CT or MR scan with a high-quality colonoscopy performed within one month of imaging.

Why it matters

Potential benefit: If successful, the tool could enable more accurate, noninvasive diagnosis and better prediction of disease course, potentially reducing reliance on invasive procedures and speeding treatment decisions.

How similar studies have gone: Prior AI research in radiology and IBD imaging has shown promising results for lesion detection and diagnosis, but fully integrated multimodal imaging platforms with prospective, real-world validation remain relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with multimodal-confirmed diagnoses (clinical, imaging, endoscopic, and pathological) of:

  * Inflammatory bowel disease (IBD; Crohn's disease or ulcerative colitis)
  * Intestinal tuberculosis
  * Behçet's disease
* Availability of ≥1 technically adequate CT or MR scan with high-quality colonoscopy performed within ±1 month of imaging.

Exclusion Criteria:

* ・Suboptimal imaging quality (e.g., low-dose artifacts, metal artifacts)

  * Inadequate bowel preparation for endoscopy
  * Incomplete examinations due to poor tolerance

Where it's running

  • XploreMET v3.0 system
    Shanghai, China
    Recruiting

Study contacts

  • Principal investigator: Xuehua Li — Sun Yat-sen University First Affiliated Hospital Department of Radiology
  • Study coordinator: Xuehua Li
  • Email: lxueh@mail.sysu.edu.cn
  • Phone: 13580364103

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.