Assessment of periodic screening of women with denser breast using WBUS and DBT

 描述（申请人提供）：关于乳腺癌早期检测筛查的有效性和最佳个体化方法的持续争议，包括常规/传统筛查方法可能导致检测到许多不太可能最终影响生存的癌症的论点，强调了研究筛查替代方法的重要性，特别是与年轻女性和/或具有比平均年龄调整的乳腺组织更致密的女性相关，这些女性处于发生乳腺癌的高风险中，并且已知常规乳房X线照相术在其中非常有限。许多州最近的倡议要求通知妇女她们的乳房密度。建议进行额外成像的女性（即，密度BIRADS 3和4）占筛选群体的40%至50%。出于此目的考虑的两种可能的高容量程序是手动或自动执行的全乳腺超声（WBUS）和正在纳入常规临床实践的数字乳腺断层合成摄影（DBT）。DBT和WBUS技术各有优点和局限性。到目前为止，重要的问题仍然存在的作用，无论是最终可能发挥筛查为基础的乳腺成像。同样重要的是，当使用DBT而不是FFDM作为基线程序时，在基于DBT的实践中，补充WBUS的边际价值问题仍然存在。因此，此时，重要的是验证/确认这些模态中的每一种的可接受性能的已证明潜力，以及联合使用这些方法时的显著性能改进，并比较这些性能水平，不仅在癌症检测和召回率方面，而且在每种成像模态可能检测到的癌症类型方面。同样重要的是，我们还将通过实验评估WBUS作为DBT筛查的补充成像程序的边际价值。该项目的目的是通过对最有可能从筛查环境中使用WBUS和/或DBT或两者中受益的妇女进行前瞻性研究来解决这些问题。我们建议在参与我们筛查计划的同意女性中依次选择人群来评估这些问题，其中包括我们12个最繁忙的站点中的4个，包括私人和学术诊所，并将涉及我们的“表现更好”的28名乳腺成像放射科医生中的12名，他们具有广泛的经验水平和实践参数。该项目对整个乳腺成像具有广泛和潜在的重要意义。我们一直作为一个综合团队在乳腺成像的所有科学、操作和临床方面进行合作，包括但不限于， DBT和WBUS。建议的项目代表了一个自然的，及时的和有必要的继续和扩大我们正在进行的研究，在这一极其重要的领域，成像为基础的筛查，以早期发现乳腺癌，特别是那些不太可能 这是“过度诊断”。

 DESCRIPTION (provided by applicant): The continuing controversy regarding the efficacy of, and optimal individualized approaches to, screening for the early detection of breast cancer, including the argument that conventional / traditional screening approaches may result in the detection of many cancers that are not likely to ultimately impact survival, stresses the importance of investigating alternative approaches to screening, in particular as related to younger women and / or women with denser than average age adjusted breast tissue who are at an elevated risk for developing breast cancer and in whom conventional mammography is known to be quite limited. Recent initiatives in many states require notifying women of their breast density. Women recommended for additional imaging (i.e., density BIRADS 3 and 4) constitutes between 40 and 50 percent of the screened population. The two possible high volume procedures being considered for this purpose are Whole Breast Ultrasound (WBUS) performed either manually or automatically and Digital Breast Tomosynthesis (DBT) that is being incorporated in routine clinical practice. Both DBT and WBUS technologies have advantages and limitations. To date, significant questions remain regarding the role that either may ultimately play in screening based breast imaging. As important, questions remain as to the marginal value of supplementary WBUS in a DBT based practice when DBT rather than FFDM is used as the baseline procedure. Therefore, at this time, it is important to validate / confirm te demonstrated potential for an acceptable performance for each of these modalities, as well as a significant performance improvement when using these approaches jointly and compare these performance levels, not only in terms of cancer detection and recall rates, but also in terms of the types of cancers likely to be detected by each imaging modality. As important, we will also assess experimentally the marginal value of WBUS as a supplementary imaging procedure to DBT based screening. The purpose of this project is to address these very issues by performing a prospective study on women who are most likely to benefit from the use of either WBUS and/or DBT or both in the screening environment. We propose to assess these questions in a sequentially selected population of consenting women participating in our screening program, which will include four of our 12 busiest sites encompassing both private and academic clinics and will involve 12 of our "better performing" 28 breast imaging radiologists with a wide range of experience levels and practice parameters. This project has broad and potentially significant implications on breast imaging as a whole. We have been collaborating as an integrated team in all scientific, operational, and clinical aspects of breast imaging, including, but not limited to, DBT and WBUS. The proposed project represents a natural, timely and warranted continuation and expansion of our ongoing investigations in this extremely important area of imaging based screening for the early detection of breast cancer, particularly those cancers that are unlikely to represent "over-diagnosis".