Development of Artificial Intelligence System for Detection and Diagnosis of Breast Lesion Using Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,809
- 试验地点
- 8
- 主要终点
- benign-malignant diagnosis accuracy
研究概览
简要总结
This project aims to establish a comprehensive artificial intelligence system for detecting and qualitative diagnosing breast lesions. Mammary images will be used to construct a diagnosis method based on deep learning. The system is proposed to automatically analyze the type of mammary glands, automatically identify and mark all breast lesions on the mammography images, provide the malignancy probability judgment of the lesions, the BI-RADS classification and the clinical suggestion, and also automatically generate the structured diagnosis report.
详细描述
This is a multi-center study.The project contains a retrospective part(3000 samples anticipated) and a prospective part(7000 samples anticipated). In the retrospective part, investigators collected subjects with mammary images to design the deep learning method and construct a detective and diagnostic model for breast lesions. In the prospective part, investigators validate the accuracy of the constructed deep learning method, and established artificial intelligence system focusing on mammary diagnosis. Investigators will also explore the application pattern of the artificial intelligence system in clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •the X-ray images of the breast were complete
- •the results of pathological diagnosis or more than 2 years of mammography follow-up were available
- •subject signs informed consent(this item was only for prospective study cases)
排除标准
- •there exists pathological diagnosis of breast lesions when receiving mammography
- •there lacks pathological diagnosis or 2 years of mammography follow-up
- •subject withdraws(this item was only for prospective study cases)
结局指标
主要结局
benign-malignant diagnosis accuracy
时间窗: from the first mammography to 2-year-after mammography
the accuracy of the AI model, radiogist with AI support, radiologist alone for binary diagnosis of a benign or malignant breast lesion according to follow up. If a 2-year mammography of BI-RADS 1/2/3 is obtained, the lesion is considered benign. If either one mammography of BI-RADS 4/5 during the two year is obtained,a pathological examination is performed to ensure the benign or malignant lesion
次要结局
- lesion detection accuracy(from the first mammography to radiologist diagnosis (within 3 days after the mammography taken))
研究者
Sun Ying-Shi
Chairman of Dept.Radiology
Peking University Cancer Hospital & Institute