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

 描述(申请人提供)：对于乳腺癌早期检测的有效性和最佳个体化筛查方法，包括传统/传统筛查方法可能会导致许多最终不太可能影响生存率的癌症的发现，持续存在争议，强调了研究替代筛查方法的重要性，尤其是与年轻妇女和/或乳房组织密度高于平均年龄调整后的乳房组织的妇女有关，她们患乳腺癌的风险较高，并且已知传统的乳房X光检查在这些人中的应用相当有限。最近在许多州采取的措施要求告知女性她们的乳房密度。建议进行额外成像(即密度为BIRAD3和4)的妇女占筛查人口的40%至50%。为此目的考虑的两种可能的大容量手术是人工或自动执行的全乳房超声(WBUS)和正在纳入常规临床实践的数字乳房断层合成(DBT)。DBT和WBUS技术都有优势和局限性。到目前为止，关于两者最终在基于乳房成像的筛查中可能起到的作用，仍然存在重大问题。同样重要的是，当DBT而不是FFDM被用作基线程序时，补充WBUS的边际价值在基于DBT的实践中仍然存在问题。因此，在这个时候，重要的是验证/确认TE对于这些模式中的每一种都具有可接受的性能的潜力，以及当联合使用这些方法时显著的性能改进，并比较这些性能水平，不仅在癌症检测和召回率方面，而且在每种成像模式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在筛查环境中最有可能从使用WBUS和/或DBT中的一种或两者中受益的妇女进行前瞻性研究来解决这些问题。我们建议对参加我们筛查计划的女性进行评估，包括我们12个最繁忙的站点中的4个，包括私人诊所和学术诊所，并将涉及我们28名表现更好的乳房影像放射科医生中的12名，他们拥有广泛的经验水平和实践参数。该项目对整个乳房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房成像的所有科学、操作和临床方面进行合作，包括但不限于， DBT和WBUS。拟议的项目代表着我们在这一极其重要的基于成像的筛查领域进行的研究的自然、及时和有理由的继续和扩大，以早期发现乳腺癌，特别是那些不太可能 代表“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".