Classification of breast masses based on visco-elastic properties

描述（由申请人提供）：本研究的目的是进行一项临床研究，以评估一种无创、定量的乳腺肿块分类/诊断工具的有效性。该项目的总体目标是应用一种称为“亚赫兹粘弹性分析（SAVE）”的技术，以增加乳房肿块特征的特异性。该技术是基于应变延迟-时间参数的测量，其特征是由于恒定力导致组织缓慢变形。该参数代表组织的粘度和弹性。该方案的新颖之处在于，与其他现有的弹性成像方法相比，SAVE技术可以探索低于1hz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该频谱范围的弹性成像方法，而拟议的研究将是第一个在大量患者身上测试该技术的研究。我们的初步结果表明，在相对较少的不可摸肿块患者中，SAVE可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（浸润性导管癌和小叶癌），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分类。这个项目包括

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.