NCT02174406已完成不适用
Clinical Utility of Whole Breast Screening Ultrasound in Patients Undergoing Digital Breast Tomosynthesis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,494
- 试验地点
- 1
- 主要终点
- estimate the cancer detection rates
研究概览
简要总结
The purpose of this study is to determine whether ultrasound or Digital breast tomosynthesis (DBT) detects more cancers and to compare the types of cancers detected on ultrasound and DBT.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Any women scheduled for screening WBUS and a screening FFDM on the same day or within the following 30 days of each other.
排除标准
- •Age < 30 years old
- •Male patients
- •Patients with any clinical symptoms (palpable mass, nipple discharge, etc)
- •Patients with known cancer
- •Patients with any breast surgery or biopsy within 90 days prior to the study
- •Patients with breast implants
- •Patients pregnant or lactating
结局指标
主要结局
estimate the cancer detection rates
时间窗: 2 years
The detection rate of each imaging test is defined as the proportion of patients who are positive on that imaging test who truly have the disease compared to the total number of women screened. A positive imaging test is defined as a test with a recommendation for biopsy (BI-RADS 4 or 5).
次要结局
未报告次要终点
研究者
研究点 (1)
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