跳至主要内容
临床试验/NCT02650778
NCT02650778已完成不适用

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

Northeastern Ohio Radiology Research and Education Fund0 个研究点目标入组 2,257 人开始时间: 2014年10月最近更新:
适应症

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

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

发起方
Northeastern Ohio Radiology Research and Education Fund
申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard G. Barr MD, PhD

Medical Director

Northeastern Ohio Radiology Research and Education Fund

相似试验