Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.
研究概览
简要总结
The study will evaluate and refine a breast screening and diagnosis device.
详细描述
The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To participate in this research study you must be a female over the age of 25
- •Have had a normal mammogram or are scheduled for a breast biopsy
- •Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.
排除标准
- •Under the age of 25
- •Documented breast cancer
研究组 & 干预措施
3D Tomosynthesis & 3D Ultrasound for breast masses
Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
干预措施: 3D Tomosynthesis and ultrasound imaging (Procedure)
3D Tomosynthesis/ 3D Ultrasound for healthy subjects
Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
干预措施: 3D Tomosynthesis and ultrasound imaging (Procedure)
结局指标
主要结局
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.
时间窗: To be determined later.
次要结局
未报告次要终点
研究者
Paul L. Carson Ph.D
Principal Investigator
University of Michigan