Automated Breast Ultrasound Screening in Women With Dense Breasts (BIRADS 3 or 4) and BIRADS Category 1 or 2 Mammogram Assigning BIRADS 3 Lesions to Yearly Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,257
- 主要终点
- Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate
研究概览
简要总结
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.
详细描述
Women with dense breasts (BIRADS 3 or 4) with a BIRADS category 1 or 2 mammogram are asked to participate in a automated volume breast ultrasound scanner. If the women agrees to participate and sign informed consent she undergoes an automated whole breast scan. The scan is interpreted independent of the mammogram. Scans are assigned a BIRADS category score of 1, 2, 3,or 0. BIRADS category 3 lesions are reported as no evidence of malignancy and a 1 year follow-up is recommended. BIRADS category 0 lesions are requested to have a hand held ultrasound including elastography. Follow up is then determined by BIRADS score and elastography results of hand held ultrasound.
The study evaluates prospectively the changes in recall rate, positive biopsy rate, cancer detection rate when BIRADS category 3 lesions are given a 1 year follow-up recommendation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women age >18 scheduled for routine screening mammogram. Women with Density 3 or 4 and BIRADS category 1 or mammogram are asked to participate in study
排除标准
- •Inability to give informed consent
结局指标
主要结局
Decreased recall rate for screening breast ultrasound while maintaining cancer detection rate
时间窗: 3 years
次要结局
- Increased positive biopsy rate(3 years)
研究者
Richard G. Barr MD, PhD
Medical Director
Northeastern Ohio Radiology Research and Education Fund
