A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,183
- 试验地点
- 5
- 主要终点
- To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images.
研究概览
简要总结
This was a multi-center, prospective clinical trial in which the subject was her own control. Approximately 950-1400 female subjects were enrolled at five (5) sites in the United States. Subjects were from either a Screening population or a biopsy population and were imaged first on a conventional 2D full filed digital mammography system then on a 3D tomosynthesis system.
The resulting images from the this portion of the study were then randomized into a reader study.
The purpose of this clinical study was to compare the 3-D tomosynthesis system used in conjunction with a conventional 2-D digital imaging system (2-D plus 3-D images) to the conventional 2-D digital imaging system (2-D images), and to determine whether the 2-D plus 3-D images compared to the 2-D images alone would:
- Reduce the recall rate And/or
- Improve ROC area due to improved breast cancer detection and/or improved lesion classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Diagnostic
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
- •Any ethnic origin
- •No contraindication for screening mammography
排除标准
- •Significant breast trauma
- •Pregnancy
- •Lactating
- •Breast implants
- •Previous breast cancer
- •Previous surgical biopsy
- •Placement of an internal breast marker
- •Unable to understand and or execute written informed consent
结局指标
主要结局
To detect a 20% reduction in the recall rate when comparing the recall rate using the BIRADS 0 scores of the 2-D plus 3-D images to the 2-D images.
时间窗: 10-12 months
次要结局
- To detect a 0.05 increase in the area under the ROC curve when comparing 2-D plus 3-D images to the 2-D images.(10-12 months)