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

筛查环境中的数字乳腺断层合成 (DBT)：一项前瞻性研究

• 批准号: 7995217
• 负责人: DAVID GUR
• 金额: $ 30.49万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7995217
• 关键词: Address; Agreement; Benign; Breast; Clinical; Clinical Research; Consent; Data; Diagnostic; Digital Mammography; Disease; Environment; Image; Information Systems; Laboratories; Malignant Neoplasms; Participant; Performance; Play; Positioning Attribute; Procedures; Prospective Studies; Qualifying; Radiology Specialty; Reader; Reporting; Research Design; Retrospective Studies; Role; Sample Size; Screening procedure; Site; Specificity; System; Technology; Testing; Time; Woman; Women' s Group; Work; arm; base; clinical practice; clinically relevant; design; digital; digital imaging; follow-up; imaging modality; improved; inclusion criteria; interest; meetings; operation; prospective; public health relevance; radiologist; research study; two-arm study

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.

描述（由申请人提供）：数字成像的最新进展，包括但不限于全场数字乳腺X线摄影（FFDM），使得数字乳腺断层合成（DBT）技术能够相对容易地实施到临床实践中。出于多种原因，单独基于 DBT 的成像和/或与 FFDM 组合的基于 DBT 的成像在筛查以及诊断性乳腺成像中引起了极大的兴趣。迄今为止，关于 DBT 最终在乳腺成像中发挥的作用仍然存在疑问。显然，在系统本身方面需要做大量的工作，而且也许重要的是，如何最好地管理和显示生成的图像数据。然而，目前最重要的是在前瞻性临床研究中确认使用 DBT 时回忆率显着降低的潜力，如回顾性研究所示。该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参与初次乳房筛查检查的年轻女性（<55 岁）的回忆率。这里提出的工作主要旨在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大影响。 公共卫生相关性：这是一项前瞻性研究，旨在检验以下假设：在筛查环境中使用 DBT 实际上可将召回率降低至少 20%。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检验这一主要假设以及重要的临床相关次要假设。