Artificial Intelligence in a Population-based Breast Cancer Screening - the Prospective Clinical Trial ScreenTrust CAD
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55,579
- 试验地点
- 2
- 主要终点
- Incident breast cancer
研究概览
简要总结
This is a prospective clinical trial following a paired screen-positive design, with the aims to assess the performance of an artificial intelligence (AI) computer-aided detection (CAD) algorithm as an independent reader, in addition to two radiologists, of screening mammograms in a true screening population. Since all decisions by individual readers will be recorded, it is possible to determine what the outcome would have been had one or two of the readers not been allowed to assess images, and to determine what the outcome would have been had the recall decision been performed by consensus decision (actual) compared to single reader arbitration of discordant cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Positive disease status is ascertained by pathology-verified breast cancer. Disease status is not known to any of the actors (except for the outcomes assessor by necessity). AI decision is not known by the care provider radiologists until they have made their decisions. In the subsequent consensus discussion where a decision is made to recall or not to recall a woman, the AI decision is known. After AI decision has been recorded and outcomes have been assessed, the investigators will have full information on outcomes and AI decisions.
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
- •Participants in regular population-based breast cancer screening at Capio St Göran Hospital
排除标准
- •Incomplete exam (complete exam: mediolateral oblique and craniocaudal images of Left and Right breast)
- •Breast implant
- •Complete mastectomy (excluded from screening positive group)
- •Participant in surveillance program for prior breast cancer
结局指标
主要结局
Incident breast cancer
时间窗: Within 23 months after screening
Breast cancer diagnosis by pathologist
次要结局
- Consensus recall(At screening)
- Tissue sampling(At screening)
- Process failure(At screening)
- Reader flagging(At screening)
研究者
Fredrik Strand
Registrar (biträdande överläkare)
Karolinska University Hospital