About this trial
This multicenter pragmatic randomized controlled trial evaluates whether AI-assisted interpretation of low-dose CT (LDCT) improves lung cancer screening performance compared with standard reading. Eligible participants are randomized to AI-assisted or conventional interpretation. The study assesses diagnostic accuracy, efficiency, lung cancer incidence, mortality, recurrence, and smoking cessation outcomes. Results will inform the clinical utility and potential implementation of AI-assisted LDCT in routine screening practice.
Eligibility criteria
Qualifiers
Family History of Lung Cancer: Males aged 45-74 or females aged 40-74 with first-degree relatives (parents, siblings, or children) diagnosed with lung cancer.
Heavy Smoking History: Ages 50-74 with ≥20 pack-years smoking history, currently smoking or quit <15 years ago.
General Screening Participants: Adults aged 40 years or older attending routine health check-ups.
Disqualifiers
Pregnant women.
Chest CT or other higher-radiation chest imaging within the past 12 months.
Individuals holding a major illness certificate for lung cancer.
Inability to undergo thoracic puncture or surgery.
Trial design
Treatments tested in this trial
- AI-assisted Low-Dose CT Interpretation
Treatment groups
Sponsors and collaborators
Taipei Veterans General Hospital, Taiwan
Lead sponsor
Far Eastern Memorial Hospital
Collaborator
Taipei Municipal Guandu Hospital
Collaborator
Da Chien General Hospital
Collaborator
Kinmen Hospital, Ministry of Health and Welfare
Collaborator
Ministry of Health and Welfare, Taiwan
Collaborator