Evaluation of AI-assisted LDCT Screening in Lung Cancer

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-74
SponsorTaipei Veterans General Hospital, Taiwan

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

1,120 Participants
are divided into 2 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