Multi-center evaluation of digital breast tomosynthesis with synthesized two-dimensional mammography for breast cancer screening

数字乳腺断层合成与合成二维乳房X线摄影用于乳腺癌筛查的多中心评估

• 批准号: 9442467
• 负责人: Emily Conant
• 金额: $ 9.31万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-12-15 至 2019-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9442467
• 关键词: Address; Adopted; Adoption; Benign; Biopsy; Breast; Breast Cancer Detection; Cancer Detection; Characteristics; Clinical; Clinical assessments; Common Data Element; Data; Databases; Detection; Diagnosis; Diagnostic; Digital Breast Tomosynthesis; Digital Mammography; Dose; Electromagnetic Energy; Evaluation; FDA approved; Frequencies; Geographic state; Goals; Health Insurance Reimbursement; Healthcare; Image; Imaging Techniques; Imaging technology; Investigation; Laws; Lesion; Link; Malignant - descriptor; Malignant Neoplasms; Mammographic Density; Mammography; Multicenter Studies; National Cancer Institute; Natural experiment; Noninfiltrating Intraductal Carcinoma; Notification; Observational Study; Outcome; Pathology; Patients; Pennsylvania; Performance; Policies; Policy Maker; Population Research; Prevalence; Provider; Radiation; Radiology Specialty; Reader; Recommendation; Regimen; Registries; Research; Risk Assessment; Roentgen Rays; Sample Size; Sensitivity and Specificity; Series; Site; Specificity; Standardization; Technology; Testing; Thinness; Time; Universities; Variant; Vermont; Woman; base; breast density; breast imaging; clinical practice; clinically significant; cost; density; follow-up; imaging facilities; improved; neoplasm registry; new technology; novel strategies; prospective; radiologist; routine screening; screening; two-dimensional

ABSTRACT Digital mammography (DM) combined with digital breast tomosynthesis (DBT) has emerged as a promising primary breast cancer screening technology with improvements in specificity and sensitivity compared to screening with DM alone. However, the total radiation dose of a combined DM/DBT study is often twice that of screening with DM alone, raising concerns about the cumulative dose over a lifetime of screening. In 2013, the FDA approved synthetic “2D-like” (s2D) images, derived from data acquired during the DBT acquisition, as a replacement for the conventional “dose” DM imaging in DBT screening. Our preliminary single site data and early reader studies suggest that s2D/DBT screening may further reduce recall and biopsy rates compared to DM/DBT, while providing high invasive breast cancer detection rates but reduced detection of ductal carcinoma in situ (DCIS). In addition, the mammographic density assignments from s2D/DBT screening changed significantly with less patients deemed “dense”, which could impact risk assessment and density-based clinical decisions regarding supplemental screening since breast density notification is mandated by laws in more than half of US states. We propose a multi-center observational study with adequate power to comprehensively characterize multiple aspects of s2D/DBT screening performance. We will leverage a natural experiment at early adopter radiology facilities participating in the University of Vermont and University of Pennsylvania PROSPR Research Centers that have transitioned from DM/DBT to s2D/DM for routine screening. Our specific aims are 1) To determine the clinical screening performance (e.g., sensitivity and specificity) of breast cancer screening with s2D/DBT; 2) To evaluate the rates of specific malignant and benign lesions detected by breast cancer screening with s2D/DBT; and 3) To determine the distribution of mammographic breast density assessments on s2D/DBT exams. For all aims, we will compare s2D/DBT screening performance to the performance of DM/DBT screening at the same facilities prior to their adoption of s2D/DBT. We anticipate a sample size of approximately 86,000 s2D/DBT exams and 98,000 DM/DBT exams. The University of Vermont and University of Pennsylvania PROSPR Research Centers have prospectively collected breast cancer screening data since 2011 in a standardized fashion to permit pooled analyses. Our registries contain exam- level breast imaging common data elements, including high quality information on indication of exam (i.e., screening vs. diagnostic), mammographic views, assessments, and breast density, linked to pathology databases and statewide cancer registries thereby permitting investigation of both benign and malignant diagnoses. The results of this project will provide needed evidence for women evaluating screening options, providers assessing whether to adopt s2D/DBT, health care payers considering reimbursement rates, and policy makers debating breast cancer screening recommendations in the context of this new technology.

摘要 数字乳腺摄影(DM)与数字乳腺断层合成(DBT)相结合已成为一种很有前途的新技术 与传统乳腺癌筛查技术相比，乳腺癌筛查技术的特异性和敏感度有所提高 单独使用DM进行筛查。然而，DM/DBT联合研究的总辐射剂量通常是 单独使用DM进行筛查，引起了人们对终生筛查累积剂量的担忧。2013年， FDA批准从DBT收购过程中获得的数据中提取的合成“类2D”(S2D)图像作为 在DBT筛查中取代传统的“剂量”DM成像。我们的初步单一站点数据和 早期读者研究表明，S2D/DBT筛查可能会进一步降低召回率和活检率 DM/DBT，虽然提供了高浸润性乳腺癌检测率，但减少了对导管癌的检测 原位(DCIS)。此外，S2D/DBT筛查的乳房X光摄影密度分配发生了变化 显著减少了被视为“密集”的患者，这可能会影响风险评估和基于密度的临床 关于补充筛查的决定，因为乳房密度通知是由法律强制在超过 美国一半的州。我们提出了一项具有足够能力的多中心观察性研究，以全面 表征S2D/DBT筛选性能的多个方面。我们将利用一项自然实验 参加佛蒙特大学和宾夕法尼亚大学的早期采用者放射学设施 PROSPR研究中心已从DM/DBT过渡到S2D/DM进行常规筛查。我们的 具体目标是1)确定乳房的临床筛查性能(例如，敏感性和特异性) 使用S2D/DBT进行癌症筛查；2)评估S2D/DBT对特定良恶性病变的检出比率 应用S2D/DBT进行乳腺癌筛查；3)确定乳房X线密度的分布 对S2D/DBT考试的评估。对于所有目标，我们将比较S2D/DBT筛查性能与 在采用S2D/DBT之前，在相同的设施中进行DM/DBT筛选。我们预计会有一个 样本大小约为86,000个S2D/DBT考试和98,000个DM/DBT考试。佛蒙特州大学 宾夕法尼亚大学PROSPR研究中心前瞻性地收集了乳腺癌 自2011年以来以标准化方式筛选数据，以便进行汇集分析。我们的登记处有考试- 水平乳房成像公共数据元素，包括关于检查指示的高质量信息(即， 筛查与诊断)、乳房X光检查、评估和乳房密度，与病理学有关 数据库和全州癌症登记，从而允许对良性和恶性的调查 诊断。该项目的结果将为妇女评估筛查方案提供必要的证据， 评估是否采用S2D/DBT的提供者，考虑报销费率的医疗保健支付者，以及 政策制定者在这项新技术的背景下辩论乳腺癌筛查建议。