AI-Assisted Chest CT Interpretation Across the Lung Cancer Care Continuum
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
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Lian Yang, PhD
- 电话号码：+86 18986273791
- 邮箱：yanglian@hust.edu.cn
学习地点
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Hubei
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Wuhan、Hubei、中国、430022
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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接触：
- Lian Yang, PhD
- 电话号码：+86 18986273791
- 邮箱：yanglian@hust.edu.cn
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
A locked research-use-only artificial intelligence system analyzes deidentified chest CT images and provides decision-support outputs to participating physicians. The system is evaluated only in an offline reader-study environment and is not used for actual patient care. |
|
实验性的：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. |
A locked research-use-only artificial intelligence system analyzes deidentified chest CT images and provides decision-support outputs to participating physicians. The system is evaluated only in an offline reader-study environment and is not used for actual patient care. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Difference in Diagnostic Accuracy Between AI-Assisted and Unaided Chest CT Interpretation
大体时间：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. |
At completion of the second reading session, after a washout period of at least 4 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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