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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Inadequate bowel preparation for endoscopy

Incomplete examinations due to poor tolerance

Trial population

This retrospective and prospective study included patients with digestive diseases. For the retrospective component, the investigators enrolled patients from 21 hospitals across China, including the First Affiliated Hospital of Sun Yat-sen University. For the prospective component, the investigators enrolled patients from the First Affiliated Hospital of Sun Yat-sen University and the Third Affiliated Hospital of Guangzhou Medical University.

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Virtual endoscopy model-assisted diagnosis

    Diagnostic test

    Using the virtual endoscopy model to aid diagnosis

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

The area under the ROC curve (AUC) to assess the performance of diagnostic model.

After baseline MR or CT scanning, patients were followed up.

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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