Evaluation of AI Medical Software-assisted LDCT Interpretation in Lung Cancer Screening and Prognosis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,120
- 试验地点
- 1
- 主要终点
- Lung Cancer Incidence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Lung Cancer Incidence
时间窗: From baseline to 12 months, 36 months, and 60 months.
The proportion of newly diagnosed lung cancer cases identified within the specified follow-up period among all individuals who underwent LDCT screening.
False Positive Rate
时间窗: Within 6 months following LDCT screening.
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.
次要结局
- Follow-up Completion Rate(Up to 12 months post-screening.)
- Smoking Cessation Rate(Assessed at 3 months, 6 months, and 12 months after baseline screening.)
- Lung Cancer Mortality(From baseline to 12 months, 36 months, and 60 months.)
- Lung Cancer Recurrence Rate(From baseline to 12 months, 36 months, and 60 months.)
- All-Cause Mortality(From baseline to 12 months, 36 months, and 60 months.)
- Time to Diagnosis(At the 12-month, 36-month, and 60-month follow-up assessments after LDCT screening.)
- Time to Treatment Initiation(At the 12-month, 36-month, and 60-month follow-up assessments after lung cancer diagnosis.)