Assessment of Digital Breast Tomosynthesis (DBT) in the Screening Environment: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 2
- 主要终点
- Number of Participants Without Cancer Who Were Recalled
研究概览
简要总结
The objective of this study is to demonstrate that digital breast tomosynthesis (DBT) in combination with full field digital mammography (FFDM) has the potential to reduce significantly baseline screening recall rates without a loss in the detection of cancers. The primary hypothesis of the study is that DBT in combination with FFDM will reduce baseline screening mammography recall rates in negative examinations by at least 20%.
详细描述
The FFDM images and the FFDM images with the DBT images will be interpreted independently by two experienced radiologists under standard clinical screening procedures. Recommended recall rates will be assessed and compared as a result of each of the two interpretations.
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
- 35 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 34 and
- •Women presenting for their baseline screening mammography examination
排除标准
- •Women with a palpable finding(s) via a Breast Self Examination (BSE) or Clinical Breast Examination (CBE).
- •Women who may be or are pregnant by self report
- •Women older than 55 years of age or younger than
- •Women with known fatty breast tissue
- •Males and children
- •Women who are unable to understand or execute written informed consent
结局指标
主要结局
Number of Participants Without Cancer Who Were Recalled
时间窗: upon recruitment/enrollment phase completion
Recall rates of digital breast tomosynthesis and full field digital mammography in younger women undergoing their initial screening mammogram will be assessed and compared.
次要结局
未报告次要终点
研究者
Jules Sumkin
Chief of Women's Imaging
University of Pittsburgh