NCT00826488已完成早期 1 期
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
研究概览
简要总结
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any race or ethnicity
- •At least 35 years old
- •Prior screening or full diagnostic mammogram at Barnes Jewish Breast Health Center
排除标准
- •Unable or unwilling to undergo informed consent
- •Subjects who have breast implants
- •Subjects who are unable or unwilling to tolerate compression
- •Subjects who are pregnant or who think they may be pregnant
- •Subjects who are currently lactating
- •Women less than 35 years old
- •Women greater than 80 years old
- •Subjects whose breasts are larger than the tomosynthesis detector
结局指标
主要结局
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
时间窗: 9 months
次要结局
未报告次要终点
研究者
Darlene Bird, R.T. (M)
Research Coordinator
Washington University School of Medicine
研究点 (2)
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