NCT01669148已完成不适用
Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 2
- 主要终点
- Detection of Breast Cancer (Sensitivity)
研究概览
简要总结
The primary hypothesis to be tested is:
The detection of breast cancer will be increased with tomosynthesis (3D) imaging
详细描述
The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Any ethnic origin
- •No contraindication for routine bilateral mammography
排除标准
- •Potential subjects with any of the following will not be enrolled in the study:
- •Any contraindications to mammographic screening, including, but not limited to:
- •Significant existing breast trauma
- •Under the age of 30 at the time of consent
- •Breast Implants
- •Prior Surgeries
- •Unable to understand and execute written informed consent
- •Lactating
结局指标
主要结局
Detection of Breast Cancer (Sensitivity)
时间窗: up to two years follow up for development of breast cancer
Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)
次要结局
未报告次要终点
研究者
Thomas J. Brady, M.D.
Vice Chairman, Radiology Research
Massachusetts General Hospital
研究点 (2)
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