Efficacy of Spot Compression Ultrasound Compared to Traditional Breast Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of breast masses detected
研究概览
简要总结
The purpose of this study is to determine the efficacy of targeted breast ultrasound ("ultrasound in the grid") performed concurrently with diagnostic mammogram during breast compression with an open mammogram paddle in lesion detection when compared to standard diagnostic breast ultrasound. Open paddle spot tomosynthesis and ultrasound in the grid images will be compared to the standard of care, and outcome measures will include comparing accuracy of lesion detection with the new technique versus the standard of care and differences in time to acquire the images for the new technique versus the current standard of care. Radiologists will also review the different sets of images and give confidence scores of lesion correspondence between mammogram and ultrasound. This will be a pilot study of 25 patients to demonstrate proof of concept and is intended to lay the foundation for future funded research with a larger patient population.
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
- 30 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mass visible on both diagnostic mammogram and ultrasound
- •Mass within the size limit to be completely confined within an open grid mammogram paddle (less than 3 cm)
排除标准
- 未提供
研究组 & 干预措施
Spot Compression Ultrasound
This arm includes all participants enrolled in the study who will receive the experimental imaging technique
干预措施: Targeted ultrasound in the grid (Diagnostic Test)
结局指标
主要结局
Number of breast masses detected
时间窗: Single visit, up to approximately one hour
The primary outcome will be whether breast masses can be detected using an open mammogram spot tomosynthesis compression paddle and targeted ultrasound in the grid using the experimental technique.
次要结局
- Time to acquire images(Single visit, up to approximately one hour)
