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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AI-assisted Low-Dose CT Interpretation
Diagnostic testParticipants 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.
Treatment groups
1,120 Participants
are divided into 2 treatment groupsGroup A: AI-assisted LDCT InterpretationExperimental treatment 1 intervention
Group B: Standard Radiologist LDCT InterpretationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Lung Cancer Incidence
The proportion of newly diagnosed lung cancer cases identified within the specified follow-up period among all individuals who underwent LDCT screening.
Time frame
From baseline to 12 months, 36 months, and 60 months.2
False Positive Rate
The proportion of LDCT screening results interpreted as positive that are subsequently confirmed as non-lung cancer based on further diagnostic imaging or pathological examination.
Time frame
Within 6 months following LDCT screening.Secondary outcomes
1
Lung Cancer Mortality
The proportion of participants who die from lung cancer within the specified follow-up period after undergoing LDCT screening.
Time frame
From baseline to 12 months, 36 months, and 60 months.2
Lung Cancer Recurrence Rate
The proportion of patients previously diagnosed and treated for lung cancer who experience disease recurrence during the follow-up period.
Time frame
From baseline to 12 months, 36 months, and 60 months.3
All-Cause Mortality
The proportion of deaths from any cause among all individuals who underwent LDCT screening during the study period.
Time frame
From baseline to 12 months, 36 months, and 60 months.4
Time to Diagnosis
The time interval from LDCT screening to the date of confirmed lung cancer diagnosis, reported at the 12-month, 36-month, and 60-month follow-up time points.
Time frame
At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
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