The Use of AI as a Third Reader and During Consensus in a Double Reading Breast Cancer Screening Program in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15,500
- 试验地点
- 1
- 主要终点
- Cancer Detection rate
研究概览
简要总结
The purpose of this observational study is to assess whether the use of AI (Transpara®) can lead to an improved quality of a double reading mammography screening program. This is investigated by performing AI as a third reader and as a decision support during the consensus meeting, compared with conventional mammography screening (double reading and consensus without AI).
详细描述
The AI cancer detection system will act as a 3rd reader and will recall additional cases to the consensus conference: the exams that were not recalled by double reading but are classified as the 3% most suspicious exams, based on AI derived cancer-risk scores. Secondly, AI is used as a decision support during consensus. AI risk scores and Computer-Aided Detection (CAD)-marks of suspicious calcifications and soft tissue lesions are provided to the reader(s).
The hypothesis of this study is that the use of AI has the potential to improve the quality of the screening program by increasing the cancer detection rate without affecting the recall rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women participating in the regular Breast Cancer Screening Program in Region Östergötland Linkoping
排除标准
- •Women with breast implants or other foreign implants in the mammogram
- •Women with symptoms or signs of suspected breast cancer
结局指标
主要结局
Cancer Detection rate
时间窗: After 4 months of inclusion
Proportion of women diagnosed with breast cancer among those recalled after consensus
Recall or referral rate
时间窗: After 4 months of inclusion
Proportion of women who are referred for further diagnostic workup after consensus
Positive predictive value of referrals
时间窗: After 4 months of inclusion
Proportion of women diagnosed with breast cancer among those referred
次要结局
- Positive predictive value of Transpara® scores(After 4 months of inclusion)
研究者
Håkan Gustafsson
Adjunct Senior Lecturer
Ostergotland County Council, Sweden