Actively Recruiting
AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases
Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-04-13
5000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new noninvasive system that uses artificial intelligence (AI) to analyze multiple types of imaging, including magnetic resonance enterography (MRE) and computed tomography enterography (CTE), to help diagnose and predict outcomes for digestive diseases. This observational study collects and analyzes retrospective imaging, endoscopic, and clinical data from 21 centers in China to build and improve the AI model. The model will then be tested prospectively in two centers and its ability to locate lesions will be checked in real-world endoscopy settings. The study involves using a virtual endoscopy model to assist in diagnosis by integrating and analyzing multimodal imaging features. The AI system is designed to support diagnosis without any invasive procedures. The study will confirm the model's accuracy and effectiveness through retrospective data, prospective validation, and real-world deployment in clinical environments. Participants will contribute data from their imaging and endoscopic exams, with at least one technically adequate CT or MR scan and a high-quality colonoscopy performed within one month of imaging. Researchers will assess the AI model's diagnostic performance by measuring the area under the ROC curve (AUC) over six months. The study includes ongoing monitoring of data quality and imaging accuracy to ensure reliable validation of the AI system.
CONDITIONS
Brief Title
AI-Driven Multimodal Imaging Integration for Diagnosis and Prognostication of Digestive System Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed diagnoses of inflammatory bowel disease (Crohn's disease or ulcerative colitis), intestinal tuberculosis, or Behçet's disease
- Availability of at least one technically adequate CT or MR scan
- High-quality colonoscopy performed within one month of imaging
You will not qualify if you...
- Imaging of suboptimal quality, including low-dose or metal artifacts
- Inadequate bowel preparation for endoscopy
- Incomplete examinations due to poor tolerance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 month
Participants undergo virtual endoscopy model-assisted diagnosis using multimodal imaging integration to aid in diagnosis of digestive system diseases.
1 to 2 visits depending on imaging and endoscopy scheduling
Duration - 6 months
Participants are observed over time to assess diagnostic accuracy and disease progression using imaging data.
Periodic assessments over 6 months
Trial Site Locations
Total: 1 location
1
XploreMET v3.0 system
Shanghai, China
Actively Recruiting
Research Team
X
Xuehua Li
Y
Yaoqi Ke
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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