RecruitingNCT07087418

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


Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Enrollment

5,000 participants

Start Date

Jul 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational, retrospective and prospective study is to develop a noninvasive disease assessment system by leveraging artificial intelligence (AI) to comprehensively analyze multi-modal imaging features, including magnetic resonance enterography (MRE) and computed tomography enterography (CTE), for the diagnosis and prognostication of digestive diseases. To this end, the investigators retrospectively enrolled imaging, endoscopic, and clinical data from 21 centers across China to construct and iteratively optimize the AI model. The model's performance will be prospectively validated in two centers, and its accuracy in lesion localization will be verified through real-world deployment in endoscopy suites.


Eligibility

Inclusion Criteria5

  • 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 Criteria3

  • ・Suboptimal imaging quality (e.g., low-dose artifacts, metal artifacts)
  • Inadequate bowel preparation for endoscopy
  • Incomplete examinations due to poor tolerance

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Interventions

DIAGNOSTIC_TESTVirtual endoscopy model-assisted diagnosis

Using the virtual endoscopy model to aid diagnosis


Locations(1)

XploreMET v3.0 system

Shanghai, China

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NCT07087418


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