NCT00990483已完成不适用
A Comparison of 15 and 30 Acquisition Angle Breast Tomosynthesis Mammography in the Visualization and Characterization of Breast Abnormalities
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
研究概览
简要总结
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female of any race and ethnicity
- •Subject is at least 40 years old
- •The screening and diagnostic mammograms were performed at the recruiting institution on a Hologic Selenia System
- •Subject is categorized as BI-RADS 0 because if mass, density, or calcifications detected on the basis of screening or diagnostic mammography
- •Subject will undergo study imaging within 30 days of standard of care imaging
排除标准
- •Patients who are pregnant or think they may be pregnant
- •Patients who are breast feeding
- •Subjects unable or unwilling to undergo informed consent
- •Subjects with breast implants
结局指标
主要结局
If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
时间窗: Fall 2010
次要结局
未报告次要终点
研究者
研究点 (2)
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