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Development and Validation of an Explainable Artificial Intelligence Model for Early Gastric Cancer Diagnosis Using Multimodal Endoscopic Imaging

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

Early gastric cancer (EGC) is often difficult to detect accurately during endoscopic examination due to subtle morphological features and variability among endoscopists. Artificial intelligence (AI) has shown promise in improving diagnostic performance; however, most existing models lack interpretability and rely on single-modality imaging. This study aims to develop and evaluate an explainable multimodal artificial intelligence model for the diagnosis of early gastric cancer using endoscopic imaging. The model integrates features derived from white-light imaging and image-enhanced endoscopy, along with quantitative image features and clinical data, to improve diagnostic accuracy and provide interpretable decision support. The primary outcome is the diagnostic performance of the AI model for detecting early gastric cancer, evaluated by area under the receiver operating characteristic curve (AUROC), sensitivity, and specificity. The results of this study are expected to provide evidence for the clinical utility of explainable AI in endoscopic diagnosis and support the development of reliable human-AI collaborative diagnostic systems.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age ≥18 years

• Suspicious gastric lesions identified on white-light imaging (WLI)

• Preoperative biopsy indicating precancerous lesions (dysplasia or intraepithelial neoplasia) or adenocarcinoma, with preoperative magnifying endoscopy with narrow-band imaging (ME-NBI) performed

• Patients meeting the absolute indications for endoscopic submucosal dissection (ESD) and who underwent ESD

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Li he Liu
lhliu2024@stu.suda.edu.cn
+8615943593759
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 100
Treatments
Early Gastric Cancer
Participants with histopathologically confirmed early gastric cancer who underwent endoscopic examination, including white-light imaging and image-enhanced endoscopy.
Non-Early Gastric Lesions
Participants with non-cancerous gastric lesions or non-early gastric cancer confirmed by histopathology who underwent endoscopic examination, including white-light imaging and image-enhanced endoscopy.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Soochow University

This content was sourced from clinicaltrials.gov