Comparing the Efficacy of 3D Ultrasound Imaging of Breast Pathology Between a Custom ITA Device and Invenia™ ABUS System by GE Medical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Breast Images
研究概览
简要总结
This comparative study will recruit 30 females who are scheduled for mammography and ultrasound assessment. The clinical 2D ultrasound is performed routinely, and the research portion of this study will add a few extra 3-D ultrasound images during the procedure. The ultrasound imaging laboratory under the direction of Dr. Aaron Fenster has developed a customized device designed to acquire 3D ultrasound of the breast using a commercial ultrasound machine. The purpose is to see how well 3-dimensional ultrasound acquire from that device is able to visualize tumours and other key features in comparison to the clinical system InveniaTM developed by GE Medical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Patients who are scheduled for screening ABUS
- •Adults Patients who are scheduled for short term follow-up with ABUS.
- •Must be at least 18 years of age or older.
- •Must be proficient in English (reading/writing).
排除标准
- •Patients with breast implants.
- •Patients with contraindication for ABUS.
- •Patients who cannot tolerate ABUS.
结局指标
主要结局
Breast Images
时间窗: 24 months
Images of the breast anatomy will be compared to standard of care imaging.
次要结局
未报告次要终点