Evaluation of a 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
A Multicenter, Controlled Clinical Trial to Evaluate the Hologic 3-D Tomosynthesis Mammography System Used in Conjunction With Conventional 2-D Digital Mammography
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
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Connecticut
-
New Haven、Connecticut、美国、06520
- Yale New Haven Hospital
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Iowa
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Iowa City、Iowa、美国、52242
- University of Iowa Medical Center
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Massachusetts
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Boston、Massachusetts、美国、02116
- Massachusetts General Hospital
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth Hitchcock Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- Magee Women's Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Female
- Any ethnic origin
- No contraindication for screening mammography
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
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.
大体时间:10-12 months
|
10-12 months
|
次要结果测量
结果测量 |
大体时间 |
---|---|
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.
大体时间:10-12 months
|
10-12 months
|
合作者和调查者
调查人员
- 首席研究员:Elizabeth Rafferty, M.D、Massachusetts General Hospital
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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