Use of Artificial Intelligence in Breast Cancer Screening: Impact of AI-Assisted Single Reading by One Radiologist on Screening Quality Indicators Compared to Standard Double Reading by Two Radiologists Without AI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8,000
- 主要终点
- Further assessment rate
研究概览
简要总结
A randomized prospective study comparing the evaluation of mammography images in a breast cancer screening programme by a single radiologist with AI support versus standard double reading by two radiologists without AI support.
详细描述
In the intervention group, the first reading of the screening mammogram will be performed by one radiologist with AI support. After this AI-assisted first reading is completed and recorded for the study, a standard second reading will be carried out by another radiologist. This ensures that the legal requirement for double reading in the breast cancer screening program is maintained.
In the control group, mammograms will be evaluated according to the current standard practice - that is, independently by two radiologists without AI support.
Participants will be divided to the two groups based on a randomization scheme that determines specific days for evaluation with AI (Group 1) and without AI (Group 2). The randomization ensures equal distribution of weekdays between the two groups to minimize bias due to variability in daily workflow, diagnostic/screening ratios, or other operational factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 45-69, asymptomatic woman participating in breast cancer screening programme
排除标准
- •clinical signs of breast disease - indication for diagnostic mammography
结局指标
主要结局
Further assessment rate
时间窗: up to 190 days after screening mammmography
The proportion of women udergoing follow-up examinations within 0-190 days after screening mammography.
次要结局
- Recall Rate(up to 190 days after screening mammography)
- Cancer Detection Rate(up to 1 year after screening mammography)