NCT07124754

Multimodal Deep Learning for Lymph Node Metastasis Prediction and Physician Performance Assessment in T1 Gastric Cancer

Development and Validation of a Multimodal Artificial Intelligence Model for Predicting Lymph Node Metastasis in T1 Gastric Cancer and Its Impact on Physician Diagnostic Performance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Qun Zhao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This study aims to develop and validate an artificial intelligence (AI) model that integrates clinical, pathological, and imaging data to predict the presence of lymph node metastasis (LNM) in patients with T1-stage gastric cancer. The study will also compare the diagnostic performance of physicians with and without AI assistance, including clinicians with varying levels of experience. The goal is to improve early decision-making and support more personalized treatment strategies for patients with early gastric cancer.

Conditions

• T1 Gastric Cancer Lymph Node Metastasis Early Gastric Cancer Artificial Intelligence-Assisted Diagnosis Multimodal Data Integration

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Multimodal Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in T1 Gastric Cancer	This intervention involves the use of a custom-built artificial intelligence (AI) diagnostic model that integrates multimodal data-including clinical variables, histopathological features, and imaging data-to predict lymph node metastasis in patients with T1-stage gastric cancer. The model provides risk probability scores and classification outputs that assist physicians in diagnostic decision-making. The AI system will be compared with physician performance at different levels of experience (resident, attending, senior) to assess its impact on diagnostic accuracy and clinical decision support.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: China