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RECRUITING
NCT07087418

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

Sponsor: First Affiliated Hospital, Sun Yat-Sen University

View on ClinicalTrials.gov

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, we 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. 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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2025-07-01

Completion Date

2026-08-01

Last Updated

2026-04-09

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Virtual endoscopy model-assisted diagnosis

Using the virtual endoscopy model to aid diagnosis

Locations (1)

XploreMET v3.0 system

Shanghai, China