Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Screening Mammography, Including Cost Comparisons
试验速览
- 阶段
- 不适用
- 入组人数
- 4,650
- 试验地点
- 2
- 主要终点
- Numbers of breast cancers detected
研究概览
简要总结
The purpose of this study is to determine whether addition of automated whole breast ultrasound to the usual screening mammography in a population of asymptomatic women with mammographically dense breasts will result in a significantly greater number of breast cancers discovered than would be found by mammography alone.
详细描述
- Study Design:
A total of sixteen thousand women at 16 centers, will be evaluated with SonoCiné automated bilateral whole breast sonography and screening mammography. In this study a motor driven carrier will be used to have the transducer examine each breast completely [Appendix A]. In this way the images can be gathered in a contiguous manner and displayed in a ciné strip and as three-dimensional images of each scan row.
These sonograms will be read by one of two designated investigator/radiologists at each site. The mammograms will be not read until after the sonogram is performed and read, and then will be read in the usual manner for that department without knowledge of the automated breast ultrasound. The mammograms will not necessarily be read by one of the investigators. The sonograms will initially be read and scored by one of the investigators at each site. These sonograms will be reviewed as ciné loops and as three-dimensional reconstructions of each scan row. The investigator will have no prior knowledge of the patient's mammogram or the reading.
The data will be entered from each site into a central computer via internet. This computer will have no personal information about any subject other than her institution ID number and her birth date. Following entry of data from the separate readings of the mammogram and sonogram, one investigator will assess any abnormal mammogram or sonogram in light of the other imaging study for that patient to evaluate whether combined readings of both studies would have effected patient management.
The investigators' call back, short-term follow-up and biopsy recommendation rates for the mammography, the sonography and the combined reading will be recorded. As with other breast imaging studies needle or open biopsies will be recommended for the mammograms and/or sonograms that are read as suspicious for carcinoma. Further diagnostic imaging studies will be ordered for any indeterminate finding. 2. Procedures for Patient Entry on Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •be at least 35 years old, unless she has a strong pre-menstrual family history of breast cancer
- •have had no screening mammogram in the past 10 months
- •agree to have a screening mammogram that will not be reviewed until after a SonoCiné is performed
- •agree to have a screening mammogram in approximately one year
- •agree to answer follow up question in approximately one year
- •meet the usual criteria for breast screening (be asymptomatic of focal breast disease)
- •have no history of breast cancer for at least one year
- •agree to have both mammogram and SonoCiné if a physical finding or mammographic finding occurs within one year that requires biopsy
排除标准
- •greater than 7 cm compressed breast thickness at mammography
结局指标
主要结局
Numbers of breast cancers detected
时间窗: One year after sonocine screening
次要结局
未报告次要终点