Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety and adverse events (AEs)
研究概览
简要总结
To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.
详细描述
Primary Objectives
- The primary objective of this proposed study is to show that bWBT (B.brilliant wide-angle breast tomosynthesis) images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging.
Secondary Objectives
- The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging.
- Additional secondary objectives include radiologist feedback on the B.brilliant images, technologist experience with B.brilliant, and a participant comfort survey.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women undergoing standard screening mammography.
- •Ability to understand and sign consent.
排除标准
- •Pregnant women.
- •Women unable to consent.
- •Male patients.
研究组 & 干预措施
Digital Breast Tomosynthesis (DBT)
Participants that agree to take part in this study, your standard follow-up imaging will be done using an FDA approved DBT system, but it will be different from the DBT system used for your routine screening. For example, if narrow-angle DBT was used for your routine screening, then you will have standard wide-angle DBT. If wide-angle DBT used for your routine screening, then you will have narrow-angle DBT. These images will be used for diagnosis and to help decide your further care.
干预措施: Digital Breast Tomosynthesis (DBT) (Device)
结局指标
主要结局
Safety and adverse events (AEs)
时间窗: Through study completion; an average of 1 year
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
次要结局
未报告次要终点