A Multicenter, Controlled Clinical Trial to Evaluate the Hologic Tomosynthesis Mammography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,521
- 试验地点
- 44
- 主要终点
- To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
研究概览
简要总结
The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any ethnic origin
- •No contraindication of routine bilateral mammography
排除标准
- •Any contraindications to mammographic screening, including but not limited to:
- •Significant existing breast trauma
- •Pregnancy
- •Lactating
- •Previous surgical biopsy
- •Previous breast cancer
- •Placement of an internal breast marker
- •Breast implants
- •Unable to understand and execute written informed consent
- •Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
结局指标
主要结局
To Demonstrate Non-inferior ROC Performance as Measured by the Area Under the Curve When Comparing 3-Ds Plus 3-D Images to the 2-D Images.
时间窗: At time of exam
ROC performance as measured by the area under the curve when comparing 3-Ds plus 3-D images to the 2-D images.
次要结局
- Analysis of ROC Performance in Subjects With Dense Breasts(At time of exam)
- Analysis of Non-Cancer Recall Rate: 3DS Compared to 2D FFDM(at time of exam)