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| Name | Class |
|---|---|
| Far Eastern Memorial Hospital | OTHER |
| Taipei Municipal Guandu Hospital | UNKNOWN |
| Da Chien General Hospital | OTHER |
| Kinmen Hospital, Ministry of Health and Welfare |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-assisted LDCT Interpretation | Experimental |
| |
| Standard Radiologist LDCT Interpretation | No Intervention | Participants undergo low-dose computed tomography (LDCT) lung cancer screening. Images are interpreted solely by radiologists without AI assistance. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted Low-Dose CT Interpretation | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 12 months, 36 months, and 60 months. |
| 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. | Within 6 months following LDCT screening. |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Cancer Mortality | The proportion of participants who die from lung cancer within the specified follow-up period after undergoing LDCT screening. | From baseline to 12 months, 36 months, and 60 months. |
| Lung Cancer Recurrence Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao-Min Cheng, M.D., Ph.D | Contact | +886-2-28712121 ext 85322 | hmcheng@vghtpe.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan | 112 | Taiwan |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| UNKNOWN |
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
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The proportion of patients previously diagnosed and treated for lung cancer who experience disease recurrence during the follow-up period.
| From baseline to 12 months, 36 months, and 60 months. |
| All-Cause Mortality | The proportion of deaths from any cause among all individuals who underwent LDCT screening during the study period. | From baseline to 12 months, 36 months, and 60 months. |
| 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. | At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening. |
| Time to Treatment Initiation | The time interval from the date of confirmed lung cancer diagnosis to the initiation of treatment, reported at the 12-month, 36-month, and 60-month follow-up time points. | At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis. |
| Follow-up Completion Rate | The proportion of individuals who completed the scheduled follow-up examinations or clinical evaluations within the designated follow-up period after undergoing LDCT screening. | Up to 12 months post-screening. |
| Smoking Cessation Rate | The proportion of individuals who successfully quit smoking within the follow-up period after LDCT screening | Assessed at 3 months, 6 months, and 12 months after baseline screening. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |