Classification of breast masses based on visco-elastic properties

基于粘弹性特性的乳腺肿块分类

• 批准号: 8843154
• 负责人: MOSTAFA FATEMI
• 金额: $ 4.19万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8843154
• 关键词: Age; American Cancer Society; Benign; Biopsy; Breast; Breast Self-Examination; Cancer Etiology; Cancerous; Categories; Cessation of life; Classification; Clinic; Clinical; Clinical Research; Collagen; Computer software; Diagnosis; Diagnostic; Discrimination; Disease; Ductal; Early Diagnosis; Early treatment; Elasticity; Emotional; Environment; Evaluation; Extracellular Matrix; Favorable Clinical Outcome; Fibroadenoma; Frequencies; Goals; High Risk Woman; Illinois; Image; Imaging Device; Imaging technology; Joints; Laboratories; Lesion; Lobular; Malignant - descriptor; Malignant Neoplasms; Mammary Gland Parenchyma; Measurement; Measures; Mechanics; Methods; Modification; Monitor; Outcome; Palpation; Pathology; Patients; Property; Recommendation; Recovery; Research; Research Design; Research Project Grants; Scientist; Sensitivity and Specificity; Signal Transduction; Skin; Specificity; Staging; Surface; Techniques; Technology; Technology Assessment; Testing; Time; Tissues; Translating; Ultrasonography; Universities; Variant; Viscosity; Visit; Woman; base; breast cancer diagnosis; breast lesion; cancer diagnosis; clinical practice; cost; density; design; elastography; experience; follow-up; high risk; imaging modality; improved; malignant breast neoplasm; novel; novel diagnostics; patient oriented; patient population; public health relevance; response; tool; viscoelasticity

DESCRIPTION (provided by applicant): The purpose of this research is to conduct a clinical study to evaluate the efficacy of a noninvasive and quantitative tool for classification/diagnosis of breast masses. The general goal of this project is to apply a technique called "Sub-Hertz Analysis of Visco-Elasticity (SAVE)", to increase specificity in the characterization of breast masses. This technique is based on measurement of the strain retardance-time parameter, which characterizes slow deformation of tissue due to a constant force. This parameter is representative of tissue viscosity and elasticity. The novelty of this proposal lies in the fact tht, in contrast to other existing elasticity imaging methods, the SAVE technique explores tissue dynamic response in the frequency range below 1 Hz. To our knowledge, our sub-Hertz method is the only elasticity imaging approach that explores this range of frequency spectrum, and the proposed research will be the first study in which this technique will be tested on a large group of patients. Our preliminary results have shown that SAVE provides reliable discrimination of benign lesions (fibrocystic change, fibroadenoma) from focal malignancies (infiltrating ductal and lobular cancers) with a remarkable specificity of 100% in a relatively small group of patients with non-palpable masses. Our general hypothesis is that by using SAVE, we will be able to improve pre-biopsy breast lesion classification in select groups of patients. This project includes the following Specific Aims: (1) Determine the specificity of SAVE by correlating its results with pathology in a population of patients with suspicious breast masses (BIRADS 4 or 5 lesions); (2) Determine the efficacy of SAVE in classifying non-specific masses in a group of breast patients on the follow- up list (BIRADS 3 lesions). Specific Aim 1 is designed to examine the efficacy of the SAVE method in patients with BIRADS 4 and 5 category lesions. In this Aim, the results of SAVE will be correlated to the biopsy results to evaluate the specificity of the proposed method in the high-risk group. Specific Aim 2 examines the patient population with probable benign breast masses, categorized as BIRADS 3 with recommendations for short-term follow up at 6-months intervals. This category is particularly challenging for both the clinician and the patient due to potentially prolonged diagnosis, stressful wait time, and the associated cost. In this aim, the results of SAVE will be correlated with the clinical results, which may include biopsy, at thei re-evaluation visit(s). Successful completion of this research will open the way for a new clinical tool that may be used for classification of breast masses. The proposed method is noninvasive, low cost, easy to use, and compatible with current ultrasound technology, which means that this technology can be readily translated to the clinic and become available to a wide range of breast patients. Consequently, this research has the potential to provide significant impact in breast cancer diagnosis and in reducing unnecessary biopsies.

描述(申请人提供)：这项研究的目的是进行一项临床研究，以评估一种非侵入性和定量工具对乳腺肿块的分类/诊断效果。该项目的总体目标是应用一种名为“亚赫兹粘弹性分析(SAVE)”的技术，以提高乳房肿块的特异度。这项技术是基于应变延迟时间参数的测量，该参数表征了由于恒定力而导致的组织缓慢变形。这个参数代表了组织的粘度和弹性。这一方案的创新之处在于，与其他现有的弹性成像方法相比，SAVE技术探测的是在1赫兹以下的频率范围内的组织动态响应。据我们所知，我们的亚赫兹方法是唯一一种探索这一频谱范围的弹性成像方法，拟议的研究将是第一次在大量患者身上测试这项技术的研究。我们的初步结果表明，SAVE可以可靠地区分良性病变(纤维囊性变、纤维腺瘤)和局灶性恶性肿瘤(浸润性导管和小叶癌)，在相对较小的未触及肿块的患者组中，特异性为100%。我们的一般假设是，通过使用SAVE，我们将能够在选定的患者组中改善活检前乳腺病变的分类。该项目包括 具体目标如下：(1)在可疑乳腺肿块(BIRADS 4或5个病变)的人群中，通过将其结果与病理相关联来确定SAVE的特异性；(2)确定SAVE在对随访列表上的一组乳房患者(BIRADS 3病变)中的非特异性肿块进行分类的有效性。具体目标1旨在检查BIRADS 4和5类病变患者的保存方法的有效性。为了达到这个目的，SAVE的结果将与活检结果相关联，以评估所提出的方法在高危人群中的特异性。具体目标2检查可能患有良性乳腺肿块的患者群体，将其归类为BIRADS 3，并建议每隔6个月进行一次短期随访。这一类别对临床医生和患者来说都是特别具有挑战性的，因为可能会延长诊断时间、紧张的等待时间和相关的成本。为此，SAVE的结果将与临床结果相关，可能包括活检，在重新评估访问(S)。这项研究的成功完成将为新的临床研究开辟道路 可用于乳房肿块分类的工具。该方法无创，成本低，使用方便，与现有的超声技术兼容，这意味着该技术可以很容易地移植到临床上，并可供更多的乳房患者使用。因此，这项研究有可能对乳腺癌的诊断和减少不必要的活检产生重大影响。