AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual endoscopy model-assisted diagnosis.
- Who it may be relevant to
- Registry conditions: Digestive Diseases, Radiology, AI (Artificial Intelligence), Imaging. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Virtual endoscopy model-assisted diagnosis
Using the virtual endoscopy model to aid diagnosis
Primary outcome measures
- The area under the ROC curve (AUC) to assess the performance of diagnostic model. [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 1 center
- XploreMET v3.0 system — Shanghai
Identifiers
NCT: NCT07087418 · 82270693