NCT00826488已完成1 期
A Comparison of Breast Tomosynthesis Mammography and Conventional Breast Imaging in the Characterization of Breast Masses: A Pilot Study
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 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
研究组 & 干预措施
observational
Other
Observational
干预措施: Digital Breast Tomosynthesis (Device)
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 (1)
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