Axial Shear Strain Elastography In Benign and Malignant Breast Disease

描述（由申请人提供）：这一系列研究的长期目标是扩大非侵入性、新型超声成像方法的开发和测试，以阐明乳腺软组织肿瘤边界及其附近发生的机械现象。这项工作的总体假设是，在轻微压缩的乳腺病变中产生的独特和新颖的轴向剪切应变填充和对比边缘区，并使用超声轴向剪切应变弹性成像成像，为标准BI-RADS（R）超声特征增加了独立的诊断特征，这将提高体内良性与恶性乳腺肿瘤非侵入性分类的灵敏度和特异性。为了验证这一假设，我们提出以下建议：修改现有的超声扫描仪软件，以提供实时ASSE显示临床使用我们将招募参与者从一个池的患者在两个医院网站进行乳房超声评价乳腺X线检查检测和/或可触及的异常。根据标准乳腺成像和报告数据系统（BIRADS）标准，需要活检的病变患者将有资格入组本研究。常规超声检查后，将获得知情同意书。然后，将由专门的乳腺放射科医生使用ASSE在单独的检查中对患者进行评估。前20名患者将作为试点研究，用于定义数据采集方案的参数。我们预计，在一年的时间内，总共将纳入150例患者。病变沿着有无轴向剪切应变区以及高对比度薄边缘将被用作ASSE的诊断特征。将由4名经过培训的观察员对ASSE功能进行评价，并对这些结果进行统计ROC分析。超声引导下的空芯针活检或手术切除将作为病理基准。 公共卫生相关性：我们在本申请中提出的研究旨在测试一种基于新的对比机制的新型超声技术，用于乳腺肿瘤分类。一旦开发，这些方法可能变得重要的（1）改善肿瘤边缘可视化的诊断和治疗，（2）良性纤维腺瘤和其他良性病变之间的区分，在体内乳腺癌，基于其独特的弹性成像轴向剪切应变签名。这种新技术可以提供强大的工具，补充和克服现有超声成像技术的一些限制，同时保持基于超声的模态的低成本、高安全性和可访问性的优点。

DESCRIPTION (provided by applicant): The long term goal of this line of research is to expand the development and testing of noninvasive, novel ultrasound imaging methodologies to elucidate the mechanical phenomena occurring at and near soft tissue tumor boundaries in the breast. The overall hypothesis of this work is that unique and novel axial-shear strain fill-in and contrasting margination zones created in slightly-compressed breast lesions and imaged with ultrasound axial shear strain elastography add an independent diagnostic feature to the standard BI-RADS(R)-ultrasound features, which will improve the sensitivity and specificity of noninvasive classification of benign vs. malignant breast tumors in-vivo. To test this hypothesis we propose the following: Modify existing ultrasound scanner software to provide real-time ASSE display for clinical use We will recruit participants from a pool of patients at a two hospital sites undergoing breast ultrasound evaluation of mammographically detected and/or palpable abnormalities. Those patients with lesions requiring biopsy as indicated by the standard Breast Imaging and Reporting Data System (BIRADS) criteria will be eligible for enrollment in the study. Following the conventional ultrasound exam, informed consent will be obtained. The patients will then be evaluated in a separate exam using ASSE to be performed by dedicated breast radiologists. The first 20 patients will serve as a pilot study for defining the parameters of the data acquisition protocol. We anticipate that a total of 150 patients over a one year period will be included. The presence or absence of axial-shear strain zones inside the lesion along with a high contrasting thin margin will be used as the diagnostic feature derived from the ASSEs. The ASSE feature will be evaluated by 4 trained observers, and statistical ROC analysis of these results will be performed. Ultrasound guided core needle biopsy or surgical excision will serve as the pathological benchmark. PUBLIC HEALTH RELEVANCE: The research we propose in this application is aimed at testing a novel ultrasound technology based on a new contrast mechanism for breast tumor classification. Once developed, these methodologies could become important for (1) improving tumor margin visualization for diagnosis and treatment, and (2) for differentiation between benign fibroadenomas and other benign pathologies, and malignant carcinomas in the breast in vivo, based on their unique elastographic axial-shear strain signatures. This novel technology may provide powerful tool that complement and overcome some of the limitations of existing ultrasound imaging techniques while maintaining the advantages of low costs, and high safety and accessibility typical of ultrasound-based modalities.