DBT use in repeat breast screening examinations_a performance assessment study

描述（由申请人提供）：乳腺成像程序的层析合成（DBT）已经研究了几年，涉及到该技术在乳腺癌早期检测筛查中的可能使用。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在美国临床使用断层合成。事实是，迄今为止，所有证明的层析合成可能带来的好处都是在适用于一小部分筛查妇女的条件下进行的测试，即那些没有事先研究可用于比较的妇女，模拟实验室对基线乳房x线照片的解释。迄今为止，在这种情况下，最大的好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，尽管程度较小。如果有的话，没有关于断层合成对重复乳房x光筛查的妇女可能产生影响的数据；因此，在筛选解释期间，可进行事先检查以进行比较。这一群体构成了大多数接受筛查的妇女（60%-90%取决于实践），与基线召回率相比，她们的召回率降低了约1.5至2倍。同样重要的是，从先前的观察（检查）中确定变化（或没有变化）可以提高放射科医生对其建议的信心水平。DBT联合全视野数字乳房x线摄影（FFDM），这是最近FDA小组审议的做法，需要大约两倍的辐射剂量。在我们在筛查环境中单方面实施DBT之前，我们需要评估在口译期间有预先检查的情况下DBT可能带来的好处。这就是这项研究的目的。为了做到这一点，我们建议在口译员有FFDM检查的情况下进行观察员表现研究。

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.