DBT use in repeat breast screening examinations_a performance assessment study

描述(申请人提供)：乳腺成像程序(DBT)的断层合成已经被研究了几年，这与这项技术在乳腺癌早期检测中的可能使用有关。最近，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，到目前为止，所有显示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，即那些没有先前可供比较的研究的妇女，在实验室模拟基线乳房X光检查的解释。在这方面迄今显示的最大好处是有可能大幅和显著降低召回率，有一些迹象表明，观察员在发现具体的“块状”异常方面的表现也可以得到改善，尽管程度较小。没有关于重复筛查乳房X光检查的妇女的断层合成的可能影响的数据；因此，在筛查解释期间可以进行先前的检查以供比较。这一群体构成了接受筛查的妇女的大多数(60%-90%，视做法而定)，她们的召回率比基线召回率低约1.5至2倍。同样重要的是，从以前的观察(检查)中确定变化(或不变化)可以提高放射科医生对他们的建议的信心水平。DBT与全视野数字乳房X光摄影(FFDM)相结合，需要大约两倍的辐射剂量，这是最近FDA小组审议的做法。在我们单方面在筛选环境中实施DBT之前，我们需要评估在口译过程中进行事先检查时DBT可能带来的好处。这正是本研究的目的所在。为此，我们建议在口译员可获得先前的口译员考试的情况下，进行一次观察员绩效研究。 与公共卫生相关：DBT与FFDM相结合，可能会在大量地点实施。正如建议批准的那样，它将需要将接受检查的乳房的辐射剂量增加一倍，因为它已经在只代表一小部分筛查女性的独特人群中进行了测试。这项研究将能够在口译员事先得到检查的情况下，评估DBT的可能好处。

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. PUBLIC HEALTH RELEVANCE: DBT in combination with FFDM is likely to be implemented in a large number of sites. As recommended for approval, it will require doubling the radiation dose to the examined breast because it has been tested in a unique population representing but a small fraction of screened women. This study will enable an assessment of the possible benefits of DBT when a prior examination is available to the interpreter.