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

使用半球阵列和逆散射对乳房进行超声成像

• 批准号: 8977104
• 负责人: ROBERT C WAAG
• 金额: $ 30万
• 依托单位: HABICO, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-04 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8977104
• 关键词: Achievement; Acoustics; Address; Algorithms; Architecture; Area; Breast; Breast Cancer Detection; Caring; Clinical; Collection; Color; Computer software; Custom; Data; Data Collection; Development; Diagnosis; Elements; Energy Transfer; Ensure; Extravasation; Foundations; Goals; High Performance Computing; Hour; Housing; Human; Image; Imaging Techniques; Implant; Institutional Review Boards; Magnetic Resonance Imaging; Malignant Neoplasms; Mammography; Marketing; Measurement; Measures; Mechanics; Medical; Medical center; Monitor; Morphologic artifacts; Morphology; Motion; Outpatients; Patients; Performance; Phase; Physiologic pulse; Policies; Process; Protocols documentation; Reporting; Research; Research Personnel; Research Subjects; Resolution; Safety; Scanning; Secure; Site; Small Business Innovation Research Grant; Speed; System; Testing; Time; Touch sensation; Transducers; Translations; Ultrasonic Transducer; Ultrasonography; Universities; Validation; Woman; attenuation; base; breast imaging; clinical efficacy; computer network; contrast imaging; cost effective; data acquisition; design; expectation; experience; high end computer; human study; human subject; image reconstruction; imaging modality; imaging software; imaging system; in vivo; indexing; innovation; instrument; malignant breast neoplasm; meetings; novel; parallel computer; patient privacy; patient safety; prototype; public health relevance; quantitative imaging; reconstruction; response; safety testing; simulation; sound; virtual

 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.

 描述（由申请人提供）：本项目的长期目标是开发一种独特的乳腺成像系统HABIS的高性能、低成本的临床原型，该系统使用非电离超声进行乳腺检查，并通过在医疗中心和门诊成像中心的系统试验来证明该系统的医疗价值和临床疗效。SBIR应用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分辨率的预期，并积累初始人体受试者图像组合，这将有助于在以后的SBIR第二阶段项目中规划更广泛的人体试验。该成像系统被设计成克服致密乳房中对比度分辨率差的X射线乳房摄影限制（即，具有高X射线衰减的乳房）、由压缩引起的不适和解剖学变形以及具有植入物的乳房的不良成像。该系统由一个定制的数据采集设备，一个高性能的计算机网络，和新的软件，控制数据的收集和形成具有各向同性高分辨率（100 µm）的体积图像。这些图像是基于逆散射以及像差校正的b扫描的声速和衰减斜率的重建。该系统的独特功能是：收集散射数据从整个乳房体积在大约两秒钟内没有任何移动部件，以尽量减少图像退化的运动，外推测量散射，以获得虚拟测量在相对半球的实际测量是不可能直接获得，并同时独立重建的子体积，以加快重建过程。第一阶段有四个具体目标：1）进行声学和电气测试，以确认HABIS对患者使用是安全的，并获得人体成像研究的批准。2)量化HABIS点和对比度分辨率，并通过使用对比度和分辨率体模图像确认分辨率符合计算的预期。3)制定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，以确保数据采集的有效验证以及定量和b扫描图像的临床审查。4)收集从10-20名具有正常和异常乳腺X线摄影结果的人类受试者中采集的HABIS图像组合，这些图像将用于指导SBIR II期项目中广泛人体试验计划的制定。第一阶段目标的主要结果将是证明HABIS符合患者安全标准，机构审查委员会批准人体研究，HABIS的量化点和对比度分辨率，适合临床合作者进行患者成像的优化HABIS软件，以及人类受试者图像，这些图像将提供HABIS医疗价值的初步证据，并指出SBIR II期人体试验中要解决的问题。该项目长期目标的实现将为其他研究奠定基础，这些研究可能会改变目前乳腺癌检测、诊断和治疗反应监测的临床成像模式。