The Performance of Digital Breast Tomosynthesis Compared to Conventional Mammography in Visualization and Characterization of Suspicious Breast Abnormalities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparison of Tomosynthesis to Standard Digital Mammography
研究概览
简要总结
In March 2009, Health Canada approved Tomosynthesis for use in screening and diagnosis of breast cancer. The Tomosynthesis technology is designed as a complementary imaging model that is incorporated into the 2D Mammography system. This new imaging system has the capability to provide 2D, 3D and combination mode models. It consists of generating thin slice images that can be viewed individually as multiple images from the same breast. Tomosynthesis provides improved visibility of possible lesions within the breast. The study aims to compare the performance of Tomosynthesis to the conventional Digital Mammography in detecting and characterizing suspicious findings in subjects who will be having breast biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female of any race and ethnicity
- •Following routine mammography imaging, subject is categorized as Breast Imaging Reporting and Data System (BI-RADS®) 4 or 5 because of calcifications / masses and architectural distortion will undergo study imaging within 30 days of routine imaging
- •Subject will undergo 2D/3D digital breast tomosynthesis prior to biopsy
排除标准
- •Subject unable or unwilling to undergo informed consent
- •Subjects who are unable or unwilling to tolerate compression
- •Subjects who are pregnant or who think they may be pregnant
- •Subjects who are breast-feeding
- •The subject is too large to be imaged on the large 24 x 30 cm detector
结局指标
主要结局
Comparison of Tomosynthesis to Standard Digital Mammography
时间窗: 2 years
To compare the sensitivity, specificity, positive and negative predictive values of tomosynthesis to conventional digital mammography in visualization and characterization of suspicious abnormalities.
次要结局
未报告次要终点