A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
研究概览
简要总结
Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.
详细描述
A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Female, any ethnic origin
- •No contraindication for diagnostic mammography
排除标准
- •Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.
- •Under 30 years of age at the time of consent
- •Unable to understand and execute written informed consent
结局指标
主要结局
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design
时间窗: 1 year
images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest
次要结局
未报告次要终点