Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
研究概览
简要总结
A standard of truth "SOT" is determined based on the interpretation results of the case data by interpretation experts, and the SOT is compared with the detection results of this program's function for detecting suspected breast cancer (CADe function). Estimate the detectability of the CADe function by comparing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 20 to 69, including those with and without breast lesions.
排除标准
- •Have a pacemaker or prosthetic valve.
- •A post-surgery follow-up patient.
研究组 & 干预措施
Define Standard of Truth (SOT) by 3 experts
Three experts A, B, and C independently define standard of truth (SOT) about 108 cases.
干预措施: Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software (Diagnostic Test)
结局指标
主要结局
The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance.
时间窗: 1 week
The average of 4 types of machines (Canon Aplio i800, GE Logiq E10, GE Invenia ABUS, Fuji ARIETTA 60) performance compared to Siemens performance which was submitted to PMDA last time.
次要结局
- The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance.(1 week)