NCT07911397Not yet recruiting
Prospective AI-Assisted Screening of Biliary Tract Cancer Using Non-Contrast CT
Prospective Clinical Validation of an Artificial Intelligence System for Biliary Tract Cancer Screening Using Non-Contrast Computed Tomography
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10000 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07911397
What you commit to
- Study type: Interventional
- Planned participants: 10000
- From 1 Oct 2026 to the primary completion date, 30 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major hepatobiliary or pancreatic surgery that substantially alters the anatomy of the liver or biliary tract and may affect AI analysis.
- Recent major upper-abdominal surgery or hepatic trauma that may substantially affect evaluation of the liver or biliary tract.
Other
- Poor image quality or severe image artifacts that preclude reliable AI analysis, including severe motion, metal, or noise artifacts.
- Inadequate scan coverage that does not include the liver and biliary tract.
- Duplicate examinations or repeated enrollment of the same participant.
- Insufficient clinical information or follow-up to establish the predefined clinical reference standard.
Who the study is looking for
- Adults aged 18 years or older.
- Undergoing abdominal non-contrast computed tomography (NCCT) as part of routine clinical evaluation or health examination.
- NCCT examination provides adequate coverage of the liver and biliary tract.
- Complete NCCT imaging data with sufficient image quality for analysis by the artificial intelligence system.
- Sufficient clinical information and/or follow-up data are available to establish the predefined clinical reference standard.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tsinghua Changgung Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.