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）：该项目的长期目标是开发一种高性能、具有成本效益的独特乳腺成像系统 HABIS 临床原型，该系统使用非电离超声检查乳腺并通过在医疗中心和门诊成像中心环境中对该系统进行试验来证明该系统的医疗价值和临床功效。该 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。对解决方案的期望，并积累初始人体图像组合，这将有助于在以后的 SBIR II 期项目中规划更广泛的人体试验。该成像系统旨在克服致密乳房中对比度分辨率差的 X 射线乳房 X 射线摄影限制。该系统由定制数据采集设备、高性能计算机网络和新颖的软件组成。控制数据的收集并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。在大约两秒内从整个乳房体积获得散射数据，无需任何移动部件，以最大限度地减少运动造成的图像质量下降，将测量到的散射外推到在不可能获得实际测量值的相反半球中获得的虚拟测量值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 对于患者使用是安全的，并确保获得人体成像研究的批准。和对比度分辨率，并通过使用对比度和分辨率模型的图像确认分辨率满足计算的期望。 3) 开发适合技术人员和牧师使用的图像采集和审查协议，并优化成像算法，以确保数据采集和临床审查的有效验证。定量的4) 收集从 10-20 名具有正常和异常乳房 X 光检查结果的人类受试者身上获取的 HABIS 图像组合，这些图像将用于指导制定 SBIR II 期广泛人体试验计划。第一阶段项目的主要成果是证明 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、适合患者的优化 HABIS 软件。由临床合作者进行的成像以及人体图像将提供 HABIS 的医学价值的初步证据，并指出 SBIR II 期人体试验中要解决的问题。该项目的长期目标的实现将为该项目奠定基础。为其他研究奠定了基础，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成像临床范式。