Early Detection of Breast Cancer Using Tomosynthesis Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 试验地点
- 2
- 主要终点
- Radiologist ROC (receiver operating characteristic) area under curve (AUC)
研究概览
简要总结
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.
详细描述
Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All Subjects accepted for this clinical study must:
- •Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications
- •Provide written informed consent
- •Be able to communicate effectively with clinical study personnel.
排除标准
- •Subjects with any of the following conditions will be excluded from this clinical study:
- •Childbearing potential and subject refuses serum pregnancy test or test result is positive.
结局指标
主要结局
Radiologist ROC (receiver operating characteristic) area under curve (AUC)
时间窗: at imaging review by the end of the study, approximately 9 years
次要结局
未报告次要终点