Axial Shear Strain Elastography In Benign and Malignant Breast Disease

描述(申请人提供)：这项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，以阐明发生在乳房软组织肿瘤边界及其附近的机械现象。这项工作的总体假设是，在轻微压缩的乳腺病变中创建独特和新颖的轴向剪切应变填充和对比边缘区域，并通过超声轴向剪切应变弹性成像成像，为标准的BI-RADS(R)超声特征增加了一个独立的诊断特征，这将提高体内乳腺良恶性肿瘤非侵入性分类的敏感度和特异度。为了验证这一假设，我们提出如下建议：修改现有的超声扫描仪软件，为临床使用提供实时的ASSE显示我们将从两家医院的患者池中招募参与者，对乳房X光检查发现和/或可触摸到的异常进行乳房超声评估。根据标准的乳腺成像和报告数据系统(BIRADS)标准，那些需要活检的患者将有资格参加这项研究。在常规的超声波检查之后，将获得知情同意。然后，患者将在一项单独的检查中进行评估，该检查将由专门的乳腺放射科医生进行ASSE检查。最初的20名患者将作为确定数据采集协议参数的试点研究。我们预计，在一年的时间里，总共有150名患者将被纳入。病变内部轴向剪切应变区的存在或不存在以及高对比度的薄边缘将被用作来自ASS的诊断特征。ASSE功能将由4名训练有素的观察员进行评估，并对这些结果进行统计ROC分析。超声引导下的芯针活检或手术切除将作为病理基准。 公共卫生相关性：我们在这项申请中提出的研究旨在测试一种新的超声技术，该技术基于一种新的对比剂机制用于乳腺肿瘤的分类。一旦开发出来，这些方法可能成为重要的(1)改善诊断和治疗的肿瘤边缘可视化，以及(2)基于其独特的弹性图轴向剪切应变特征，在体内区分良性纤维腺瘤和其他良性病变以及乳腺恶性肿瘤。这一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局限性，同时保持基于超声的模式典型的低成本、高安全性和可获得性的优势。

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.