Evaluation of AI-assisted LDCT Screening in Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-assisted Low-Dose CT Interpretation.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 40 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of AI Medical Software-assisted LDCT Interpretation in Lung Cancer Screening and Prognosis: a Randomized Controlled Trial
Overview
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.
Detailed description
Lung cancer is a leading cause of cancer-related mortality worldwide, and early detection is essential for improving survival. Low-dose computed tomography (LDCT) has been shown to reduce lung cancer mortality in high-risk populations, but image interpretation is time-consuming and may lead to overdiagnosis. Artificial intelligence (AI)-assisted diagnostic tools offer the potential to improve accuracy and efficiency in LDCT-based lung cancer screening, though challenges related to model adaptability, data heterogeneity, user trust, and regulatory compliance remain.
This multicenter pragmatic randomized controlled trial evaluates the effectiveness of AI-assisted LDCT interpretation compared with standard interpretation. Eligible participants will be randomized to an AI-assisted arm or a standard-reading arm. Outcomes include diagnostic accuracy, efficiency, lung cancer incidence, lung cancer mortality, recurrence, and smoking cessation.
The findings will provide evidence on the clinical utility of AI-assisted LDCT screening and support future implementation in routine practice and policy development.
Interventions
- Diagnostic test AI-assisted Low-Dose CT Interpretation
Participants undergo low-dose computed tomography (LDCT) lung cancer screening. The images are first interpreted by AI-assisted software, which highlights suspicious nodules. Radiologists then review the AI outputs and generate the final report.
Primary outcome measures
- Lung Cancer Incidence [Time frame: From baseline to 12 months, 36 months, and 60 months.]
- False Positive Rate [Time frame: Within 6 months following LDCT screening.]
Secondary outcome measures (7)
- Lung Cancer Mortality [Time frame: From baseline to 12 months, 36 months, and 60 months.]
- Lung Cancer Recurrence Rate [Time frame: From baseline to 12 months, 36 months, and 60 months.]
- All-Cause Mortality [Time frame: From baseline to 12 months, 36 months, and 60 months.]
- Time to Diagnosis [Time frame: At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.]
- Time to Treatment Initiation [Time frame: At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.]
- Follow-up Completion Rate [Time frame: Up to 12 months post-screening.]
- Smoking Cessation Rate [Time frame: Assessed at 3 months, 6 months, and 12 months after baseline screening.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Inability to hold breath or otherwise complete the scanning procedure.
- Hemoptysis of unknown cause within the past month.
- Chest X-ray within the past month showing suspicious lung lesions.
- Unexplained weight loss >6 kg within the past year.
- History of lung cancer within the past three years.
- Presence of other severe diseases with an expected life expectancy <5 years.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
Taiwan · 1 center
- Taipei Veterans General Hospital — Taipei
Identifiers
NCT: NCT07280559 · 2025-11-002AU-3AI