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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Enrolling

Conditions

Radiology
Imaging
AI (Artificial Intelligence)
Digestive Diseases

Treatments

Diagnostic Test: Kaplan-Meier analysis with log-rank testing

Study type

Observational

Funder types

Other

Identifiers

NCT07087418
82270693

Details and patient eligibility

About

The goal of this observational study is to 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.

Participants will be randomly assigned to either conventional endoscopy or virtual endoscopy groups. The predictive performance of both groups for prognostic indicators, such as clinical remission rate and recurrence risk, will be compared during follow-up to verify the non-inferiority of the virtual endoscopy group.

Enrollment

5,000 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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

Trial design

5,000 participants in 2 patient groups

Conventional endoscopy group
Description:
Prognostic indicators (e.g., clinical remission rate, recurrence risk) were predicted using conventional endoscopy at baseline.
Treatment:
Diagnostic Test: Kaplan-Meier analysis with log-rank testing
Virtual endoscopy group
Description:
Prognostic indicators were predicted using virtual endoscopy at baseline.
Treatment:
Diagnostic Test: Kaplan-Meier analysis with log-rank testing

Trial contacts and locations

1

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Central trial contact

Xuehua Li; Yaoqi Ke

Data sourced from clinicaltrials.gov

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