DBT use in repeat breast screening examinations_a performance assessment study

DBT 在重复乳腺筛查检查中的应用_性能评估研究

• 批准号: 8618782
• 负责人: Christiane M Hakim
• 金额: $ 24.39万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-06 至 2016-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8618782
• 关键词: Area; Benign; Biopsy; Breast; Breast Cancer Early Detection; Clinic; Clinical; Data; Data Set; Digital Mammography; Dose; Environment; Image; Imaging Techniques; Laboratories; Lesion; Malignant Neoplasms; Mammography; Participant; Performance; Pilot Projects; Population; Positioning Attribute; Procedures; Process; Protocols documentation; Radiation; Reader; Reading; Recommendation; Sampling; Simulate; Site; Technology; Testing; Time; United States; United States Food and Drug Administration; Voting; Woman; Women' s Group; arm; base; calcification; cost; experience; high risk; improved; radiologist; screening

DESCRIPTION (provided by applicant): Tomosynthesis of breast imaging procedures (DBT) has been investigated for several years as related to the possible use of this technology in screening for the early detection of breast cancer. Recently, a Food and Drug Administration (FDA) panel voted to strongly recommend approval for the clinical use of tomosynthesis in the United States. The fact is that, to date, all demonstrated possible benefits of tomosynthesis have been tested under conditions that apply to a small fraction of screened women, namely those without prior studies available for comparison, simulating the interpretation of baseline mammograms in the laboratory. The largest benefit demonstrated to date in this context is the possibility of substantially and significantly reducing recall rates, with some indications that observer performance in detecting specific "mass like" abnormalities could also be improved, albeit to a lesser extent. There are no data regarding the possible impact, if any, of tomosynthesis for women who have repeat screening mammograms; hence, a prior examination is available for comparison during the screening interpretation. This group constitutes the majority of screened women (60%-90% depending on the practice) and their recall rates are lower by approximately a factor of 1.5 to 2 as compared with baseline recall rates. As important, determining change (or no change) from prior observations (examinations) raises radiologists' confidence levels regarding their recommendations. DBT in combination with full field digital mammography (FFDM), which is the practice as presented for consideration before the recent FDA panel, requires approximately doubling the radiation dose. Before we unilaterally implement DBT in the screening environment, we need to assess the possible benefits of DBT when a prior examination is available during the interpretation. This is the very purpose of this study. To do so we propose to perform an observer performance study when prior FFDM examinations are available to the interpreter.

描述（由申请人提供）：乳腺成像程序（DBT）的断层合成已研究了数年，因为该技术可能用于筛查乳腺癌的早期检测。最近，美国食品和药物管理局（FDA）的一个小组投票强烈建议批准断层合成在美国的临床应用。事实是，迄今为止，所有证明的断层合成可能的好处都是在适用于一小部分筛查妇女的条件下进行测试的，即那些没有先前研究可供比较的妇女，模拟实验室中基线乳房X线照片的解释。迄今为止，在这种情况下证明的最大益处是有可能大幅降低召回率，一些迹象表明，观察者在检测特定“肿块样”异常方面的表现也可以得到改善，尽管程度较低。没有关于断层合成摄影对重复筛查乳腺X线摄影的女性的可能影响（如果有的话）的数据;因此，在筛查解释期间，可以使用既往检查进行比较。这一组构成了筛查女性的大多数（60%-90%，取决于实践），与基线回忆率相比，他们的回忆率低约1.5至2倍。同样重要的是，确定先前观察（检查）的变化（或无变化）提高了放射科医生对其建议的信心水平。DBT与全视野数字乳腺X射线摄影（FFDM）结合使用（这是最近FDA专家组考虑的实践）需要大约加倍的辐射剂量。在我们单方面在筛查环境中实施DBT之前，我们需要评估在口译期间进行预先检查时DBT可能带来的好处。这正是本研究的目的所在。要做到这一点，我们建议进行观察员的性能研究时，前FFDM检查可供口译员。