Clinical Research Directory

Prospective AI-Assisted Screening of Biliary Tract Cancer Using Non-Contrast CT

Sponsor: Beijing Tsinghua Chang Gung Hospital

Summary

Biliary tract cancer is a group of malignant tumors involving the intrahepatic bile ducts, extrahepatic bile ducts, and gallbladder. Early detection can be challenging because non-contrast computed tomography (NCCT), which is commonly performed in routine clinical practice, may provide limited information for identifying biliary tract cancer. This prospective study aims to clinically validate an artificial intelligence (AI) system for screening and detecting biliary tract cancer on NCCT images. The AI system will independently analyze eligible NCCT examinations and generate a patient-level risk score for biliary tract cancer. The study will evaluate the diagnostic performance of the AI system against a predefined clinical reference standard. The primary objective is to assess the ability of the AI system to distinguish patients with biliary tract cancer from those without biliary tract cancer using NCCT. Secondary objectives include evaluating sensitivity, specificity, positive predictive value, and negative predictive value. The study is designed to evaluate the clinical performance and potential screening value of AI-assisted analysis of NCCT. Routine clinical care and clinical decision-making will not be replaced by the AI system.

Official title: Prospective Clinical Validation of an Artificial Intelligence System for Biliary Tract Cancer Screening Using Non-Contrast Computed Tomography

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