Digital Breast Tomosynthesis (DBT) in a Screening Environment: a Prospective Stud

描述(申请人提供)：数字成像的最新进展，包括但不限于全场数字乳房摄影(FFDM)，使数字乳房断层合成(DBT)技术能够相对容易地实施到临床实践中。基于DBT的成像单独和/或与FFDM结合在筛查和诊断性乳房成像中具有很大的兴趣，原因有几个。到目前为止，关于DBT最终可能在乳房成像中扮演的角色的问题仍然存在。显然，在系统本身以及如何最好地管理和显示所生成的图像数据方面都需要做大量的工作，这一点或许很重要。然而，在这个时候，最重要的是在前瞻性的临床研究中确认使用DBT时召回率显著降低的可能性，如回顾研究所示。该项目的目的是通过对最有可能从将DBT纳入筛查环境中受益的妇女进行一项有限的前瞻性研究来解决这一问题。我们建议评估和比较参加初次乳房筛查的年轻女性(55岁)的召回率。这里提出的工作主要是为了在筛查环境中结合使用DBT成像和FFDM，但该项目也对诊断性乳腺成像具有广泛和潜在的重要意义。 与公共健康相关：这是一项前瞻性研究，旨在测试以下假设：在筛查环境中使用DBT实际上会使召回率降低至少20%。一种独特的研究设计将能够对最有可能从这种成像和检查管理方法中受益的女性群体进行这一主要假设以及重要的临床相关次要假设的测试。

DESCRIPTION (provided by applicant): Recent advances in digital imaging, including but not limited to Full Field Digital Mammography (FFDM), has enabled a relatively easy implementation of Digital Breast Tomosynthesis (DBT) technology into the clinical practice. DBT based imaging alone and /or in combination with FFDM is of great interest in screening as well as in diagnostic breast imaging for several reasons. To date questions remain regarding the role that DBT may ultimately play in breast imaging. It is clear that significant work needs to be done in terms of both the systems themselves and, as important perhaps, how to best manage and display the generated image data. However, at this time it is most important to confirm in a prospective clinical study the demonstrated potential for a significant decrease in recall rates when using DBT, as shown in retrospective studies. The purpose of this project is to address this very point by performing a limited prospective study on women who are most likely to benefit from the inclusion of DBT in the screening environment. We propose to assess and compare the recall rates in younger women (<55YO) participating in their initial breast screening examination. The work proposed here is aimed primarily at the use of DBT imaging in combination with FFDM in the screening environment, but this project has broad and potentially significant implications on diagnostic breast imaging as well. PUBLIC HEALTH RELEVANCE: This is a prospective study to test the hypothesis that the use of DBT in the screening environment actually reduces recall rates by at least 20%. A unique study design will enable the testing of this primary hypothesis, as well as important clinically relevant secondary hypotheses, on the group of women who are most likely to benefit from this imaging and examination management approach.