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

描述（由申请人提供）：数字成像的最新进展，包括但不限于全视野数字乳腺X射线摄影（FFDM），使得数字乳腺断层合成（DBT）技术能够相对容易地应用于临床实践。基于DBT的成像单独和/或与FFDM组合在筛查以及诊断乳腺成像中具有很大的意义，原因有几个。迄今为止，关于DBT最终可能在乳腺成像中发挥的作用仍存在问题。很明显，在系统本身以及（也许同样重要的是）如何最好地管理和显示生成的图像数据方面都需要做大量的工作。然而，目前最重要的是在前瞻性临床研究中证实，如回顾性研究所示，使用DBT时，召回率有可能显著降低。本项目的目的是通过对最有可能从筛查环境中纳入DBT中受益的女性进行有限的前瞻性研究来解决这一问题。我们建议评估和比较年轻女性（<55岁）参与初次乳腺筛查检查的回忆率。本文提出的工作主要针对在筛查环境中结合使用DBT成像和FFDM，但该项目对诊断乳腺成像也具有广泛且潜在的重要意义。 公共卫生相关性：这是一项前瞻性研究，旨在验证在筛查环境中使用DBT实际上至少降低了20%的召回率的假设。一个独特的研究设计将使测试的主要假设，以及重要的临床相关的次要假设，对妇女谁是最有可能受益于这种成像和检查管理方法。

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.