Evaluation of AI-assisted LDCT Screening in Lung Cancer
NCT ID: NCT07280559
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1120 participants
INTERVENTIONAL
2025-12-11
2031-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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AI-assisted LDCT Interpretation
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.
Standard Radiologist LDCT Interpretation
Participants undergo low-dose computed tomography (LDCT) lung cancer screening. Images are interpreted solely by radiologists without AI assistance.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Heavy Smoking History: Ages 50-74 with ≥20 pack-years smoking history, currently smoking or quit \<15 years ago.
3. General Screening Participants: Adults aged 40 years or older attending routine health check-ups.
Exclusion Criteria
2. Chest CT or other higher-radiation chest imaging within the past 12 months.
3. Individuals holding a major illness certificate for lung cancer.
4. Inability to undergo thoracic puncture or surgery.
5. Inability to hold breath or otherwise complete the scanning procedure.
6. Hemoptysis of unknown cause within the past month.
7. Chest X-ray within the past month showing suspicious lung lesions.
8. Unexplained weight loss \>6 kg within the past year.
9. History of lung cancer within the past three years.
10. Presence of other severe diseases with an expected life expectancy \<5 years.
40 Years
74 Years
ALL
Yes
Sponsors
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Far Eastern Memorial Hospital
OTHER
Taipei Municipal Guandu Hospital
UNKNOWN
Da Chien General Hospital
OTHER
Kinmen Hospital, Ministry of Health and Welfare
UNKNOWN
Ministry of Health and Welfare, Taiwan
OTHER_GOV
Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Locations
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Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-11-002AU-3AI
Identifier Type: -
Identifier Source: org_study_id
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