Development of a Chest CT-Based Artificial Intelligence Model Across the Lung Cancer Care Continuum and a Prospective Randomized Crossover Reader Study of Its Clinical Decision-Support Performance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Difference in Diagnostic Accuracy Between AI-Assisted and Unaided Chest CT Interpretation
研究概览
简要总结
This investigator-initiated, single-center study consists of a retrospective artificial intelligence model-development stage and a prospective physician reader-study stage. Deidentified chest CT examinations acquired during routine clinical care between January 1, 2021, and December 31, 2024, will be used to develop, validate, and lock artificial intelligence models for lung cancer-related imaging tasks.
In the prospective stage, approximately 12 to 15 physicians with experience in chest CT interpretation will complete two reading sessions in randomized order: unaided interpretation and AI-assisted interpretation. The sessions will be separated by a washout period of at least 4 weeks. The primary objective is to compare diagnostic performance between AI-assisted and unaided interpretation. Secondary objectives include reading time, diagnostic confidence, inter-reader agreement, and errors related to incorrect AI suggestions.
All readings will be performed in an offline research environment. AI outputs will not be used for patient care, and the study will not add imaging examinations, treatment, or follow-up for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physicians with education or training relevant to medical imaging
- •Experience in interpreting chest CT examinations
- •Ability to complete the required study training and both reading sessions
- •Willingness to provide written informed consent and comply with study procedures
排除标准
- •Failure to complete the required study training
- •Inability or unwillingness to complete both reading sessions as required
- •Any protocol deviation likely to compromise the validity of the reader-study data
研究组 & 干预措施
Sequence AB: Unaided Then AI-Assisted Interpretation
Participants first complete an unaided chest CT interpretation session. After a washout period of at least 4 weeks, they complete an AI-assisted interpretation session.
干预措施: Chest CT Artificial Intelligence Decision-Support System (Device)
Sequence BA: AI-Assisted Then Unaided Interpretation
Participants first complete an AI-assisted chest CT interpretation session. After a washout period of at least 4 weeks, they complete an unaided interpretation session.
干预措施: Chest CT Artificial Intelligence Decision-Support System (Device)
结局指标
主要结局
Difference in Diagnostic Accuracy Between AI-Assisted and Unaided Chest CT Interpretation
时间窗: At completion of the second reading session, after a washout period of at least 4 weeks
Diagnostic accuracy will be calculated as the proportion of case-level interpretations that agree with the prespecified reference standard based on pathology or clinical follow-up. The paired difference in diagnostic accuracy between AI-assisted and unaided interpretation will be estimated across participating physicians and cases using a multi-reader multi-case analysis and reported with a 95% confidence interval. Higher accuracy indicates better diagnostic performance.
次要结局
未报告次要终点