An interventional study of AI-Assisted Biliary Tract Cancer Screening Using NCCT in Biliary Tract Cancer (BTC), sponsored by Beijing Tsinghua Chang Gung Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Diagnostic
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.
519 studies on the registry are indexed under Biliary Tract Neoplasms; 199 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 58 across 427 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Participants in this arm will undergo AI-assisted screening for biliary tract cancer using non-contrast computed tomography (NCCT). The artificial intelligence system will independently analyze eligible NCCT examinations and generate a patient-level risk score for biliary tract cancer. The AI output will be evaluated against a predefined clinical reference standard. Routine clinical interpretation and patient management will not be replaced by the AI system.
Diagnostic Test: AI-Assisted Biliary Tract Cancer Screening Using NCCT
An artificial intelligence system that analyzes non-contrast computed tomography (NCCT) examinations to screen for biliary tract cancer. The system independently processes eligible NCCT images and generates a patient-level risk score indicating the likelihood of biliary tract cancer. The AI output will be evaluated against a predefined clinical reference standard. The system is intended to support the detection of biliary tract cancer and does not replace routine clinical interpretation or independently determine patient management.
Patient-level area under the receiver operating characteristic curve (AUC) of the AI system for distinguishing biliary tract cancer from non-biliary-tract-cancer cases using non-contrast computed tomography (NCCT)
The primary outcome is the patient-level area under the receiver operating characteristic curve (AUC) for the AI system in distinguishing biliary tract cancer from non-biliary-tract-cancer cases using non-contrast computed tomography (NCCT). Biliary tract cancer includes intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, distal cholangiocarcinoma, and gallbladder cancer. The reference diagnosis will be established using the predefined clinical reference standard.
Time frame: From the index NCCT examination to completion of the reference standard assessment, up to 30 days
Sensitivity of the AI system for detecting biliary tract cancer
Sensitivity of the AI system for identifying patients with biliary tract cancer using non-contrast computed tomography (NCCT), based on the predefined clinical reference standard. Biliary tract cancer includes intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, distal cholangiocarcinoma, and gallbladder cancer.
Time frame: From the index NCCT examination to completion of the reference standard assessment, up to 30 days
Specificity of the AI system for identifying non-biliary-tract-cancer cases
Specificity of the AI system for identifying patients without biliary tract cancer using non-contrast computed tomography (NCCT), based on the predefined clinical reference standard.
Time frame: From the index NCCT examination to completion of the reference standard assessment, up to 30 days
Positive predictive value of the AI system for biliary tract cancer
Positive predictive value of the AI system for identifying biliary tract cancer using non-contrast computed tomography (NCCT), based on the predefined clinical reference standard.
Time frame: From the index NCCT examination to completion of the reference standard assessment, up to 30 days
Negative predictive value of the AI system for biliary tract cancer
Negative predictive value of the AI system for excluding biliary tract cancer using non-contrast computed tomography (NCCT), based on the predefined clinical reference standard.
Time frame: From the index NCCT examination to completion of the reference standard assessment, up to 30 days
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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