Ultrasound Imaging of Breast by Use of a Hemispheric Array and Inverse Scattering

 描述(申请人提供)：该项目的长期目标是开发一种独特的乳房成像系统Habis的高性能、低成本的临床原型，该系统使用非电离超声波检查乳房，并通过在医疗中心和门诊成像中心环境中对该系统的试验来证明该系统的医疗价值和临床疗效。该SBIR应用程序第一阶段的直接目标是确认Habis满足声学和电气安全要求以及对分辨率的期望，并积累初始人体受试者图像组合，这将有助于在稍后的SBIR第二阶段项目中规划更广泛的人体试验。该成像系统旨在克服X光乳房X光成像的局限性，即致密乳房(即X光衰减较高的乳房)对比度分辨率较差，受压导致的不适和解剖变形，以及植入乳房的成像不佳。该系统由定制的数据采集设备、高性能计算机网络和控制数据采集并形成各向同性高分辨率(100微米)的体积图像的新颖软件组成。这些图像是基于反向散射和像差校正的b扫描重建的声速和衰减斜率。该系统的独特功能是：在没有任何移动部件的情况下，在大约两秒内收集整个乳房体积的散射数据，以将运动造成的图像退化降至最低；对测量的散射进行外推，以获得无法直接获得实际测量的对侧半球的虚拟测量；以及同时独立重建子体积，以加快重建过程。第一阶段有四个具体目标：1)进行声学和电学测试，以确认哈比斯对患者使用是安全的，并确保人体成像研究获得批准。2)量化哈比斯点和对比度分辨率，并使用对比度和分辨率模体图像确认分辨率满足计算期望。3)开发适合技术人员和临床医生使用的图像采集和审查协议，并优化成像算法，以确保定量图像和b超图像的数据采集和临床审查的有效验证。4)收集从10-20名具有正常和异常乳房X光检查结果的受试者身上获得的Habis图像组合，这些图像将用于指导制定SBIR第二阶段项目中广泛的人体试验计划。第一阶段目标的主要结果将是证明哈比斯符合患者安全标准、机构审查委员会对人体试验的批准、哈比斯的量化点数和对比度分辨率、适用于临床合作者进行的患者成像的优化哈比斯软件，以及将提供哈比斯医疗价值的初步证据并指出在SBIR第二阶段人体试验中需要解决的问题的人体受试者图像。该项目长期目标的实现将为其他研究奠定基础，这些研究可能改变目前用于乳腺癌检测、诊断和治疗反应监测的临床成像范例。

 DESCRIPTION (provided by applicant): The long-term objectives of this project are to develop a high-performance, cost-effective clinical prototype of a unique breast imaging system, HABIS, that uses non-ionizing ultrasound for examination of the breast and to demonstrate the medical value and clinical efficacy of the system through trials of the system in medical-center and outpatient imaging-center settings. The immediate objectives in Phase I of this SBIR application are to confirm that HABIS meets acoustic and electrical safety requirements as well as expectations for resolution, and to accumulate a portfolio of initial human subject images that will aid the planning of more extensive human trials in a later SBIR Phase-II project. The imaging system is designed to overcome x-ray mammography limitations of poor resolution of contrast in dense breasts (i.e., breasts with high x-ray attenuation), discomfort and anatomical deformation induced by compression, and poor imaging of breasts with implants. The system consists of a custom data-acquisition apparatus, a high-performance computer network, and novel software that controls the collection of data and forms volumetric images having isotropic high resolution (100 µm). These images are reconstructions of sound speed and attenuation slope based on inverse scattering as well as aberration-corrected b-scans. Unique features of the system are: collection of scattering data from the entire breast volume in about two seconds without any moving parts to minimize image degradation from motion, extrapolation of measured scattering to obtain virtual measurements in the opposite hemisphere where actual measurements are impossible to obtain directly, and simultaneous independent reconstruction of subvolumes to speed the reconstruction process. Phase I has four specific aims: 1) Conduct acoustic and electrical tests to confirm that HABIS is safe for patient use and secure approval for human imaging studies. 2) Quantify HABIS point and contrast resolution and confirm that resolution meets calculated expectations by using images of contrast and resolution phantoms. 3) Develop image acquisition and review protocols suitable for use by technicians and clinicians, and optimize imaging algorithms to ensure efficient validation of data acquisition and clinical review of quantitative and b-scan images. 4) Assemble a portfolio of HABIS images acquired from 10-20 human subjects with normal as well as abnormal mammographic results that will be used to guide the development of a plan for extensive human trials in an SBIR Phase-II project. The major results of the Phase-I aims would be proof that HABIS complies with standards for patient safety, approval for human studies by an institutional review board, quantified point and contrast resolution of HABIS, optimized HABIS software suitable for patient imaging to be conducted by clinical collaborators, and human subject images that will provide preliminary evidence of the medical value of HABIS and indicate questions to be addressed in SBIR Phase-II human trials. Achievement of the long-term goals of this project would lay the foundation for additional studies that could change the present clinical paradigm of imaging for breast-cancer detection, diagnosis, and monitoring of response to treatment.