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，以评价用于乳腺肿块分类/诊断的无创定量工具的有效性。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，以增加乳腺肿块特征的特异性。该技术基于应变延迟时间参数的测量，该参数表征由于恒定力引起的组织的缓慢变形。该参数代表组织粘度和弹性。该建议的新奇在于，与其他现有的弹性成像方法相比，SAVE技术探索在低于1Hz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，而这项研究将是第一项在大量患者身上测试这项技术的研究。我们的初步研究结果表明，SAVE提供了可靠的区分良性病变（纤维囊性变，纤维腺瘤）从局灶性恶性肿瘤（浸润性导管和小叶癌）与一个显着的特异性为100%，在一个相对较小的一组患者与不可触及的肿块。我们的一般假设是，通过使用SAVE，我们将能够改善选定患者组的活检前乳腺病变分类。这个项目包括 以下具体目标：（1）通过将SAVE的结果与具有可疑乳腺肿块（BIRADS 4或5个病变）的患者群体中的病理学相关联来确定SAVE的特异性;（2）确定SAVE在对随访列表上的一组乳腺患者（BIRADS 3个病变）中的非特异性肿块进行分类中的功效。具体目标1旨在检查SAVE方法在BIRADS 4和5类病变患者中的有效性。在该目的中，SAVE的结果将与活检结果相关联，以评价所提出的方法在高危组中的特异性。特定目标2检查了可能患有良性乳腺肿块的患者人群，分类为BIRADS 3，建议以6个月为间隔进行短期随访。由于潜在的延长诊断、紧张的等待时间和相关的成本，这一类别对临床医生和患者都特别具有挑战性。为此，SAVE的结果将与再评价访视时的临床结果（可能包括活检）相关联。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。所提出的方法是非侵入性的，成本低，易于使用，并与当前的超声技术兼容，这意味着该技术可以很容易地转化为临床，并可用于广泛的乳腺患者。因此，这项研究有可能对乳腺癌诊断和减少不必要的活检产生重大影响。

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.