Development of a 3-D multi-planar biopsy system using new ultrasound tomographic

使用新型超声断层扫描技术开发 3D 多平面活检系统

基本信息

批准号：
8710749
负责人：
Olivier Roy
金额：
$ 18.42万
依托单位：
DELPHINUS MEDICAL TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-07-01 至 2015-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8710749
关键词：
3-Dimensional Address Anatomy Architecture Bathing Biopsy Biopsy Specimen Breast Breast Cancer Detection Clinic Clinical Clinical Engineering Communities Computer Simulation Computer software Core Biopsy Coupling Data Delphinus Development Devices Diagnosis Engineering Environment Evaluation Future General Population Goals Gold Hand High Risk Woman Human Image Image Guided Biopsy Imaging technology Injection of therapeutic agent Interdisciplinary Study Lead Magnetic Resonance Mammography Medical Medical Technology Modality Modification Molecular Names Performance Phase Positron Preparation Process Prone Position Readiness Resolution Risk Role Sampling Scanning Second Look Surgery Services Simulate Solutions Speed Staging Supine Position System Techniques Technology Testing Transducers Translating Translations Ultrasonography Water Woman Work base commercialization cost cost effective data acquisition design experience high risk image reconstruction imaging modality malignant breast neoplasm novel phase 1 study product development public health relevance sample fixation screening tomography

项目摘要

PROJECT SUMMARY Biopsy capability is an absolute requirement for imaging facilities planning to provide breast cancer screening services. The limitations of mammography have ushered in several other imaging technologies, such as magnetic resonance (MR), positron emission mammography, and breast specific gamma, or molecular breast imaging. However, these are all relatively expensive modalities and require contrast injection, limiting their potential use for screening of the general population. We therefore developed a more quantitative and less expensive approach for evaluation of breast masses using the principles of ultrasound tomography (UST). Our new commercial UST scanner, named SoftVue (Delphinus Medical Technologies), now has sufficient resolution, contrast and speed to address the burden of screening of the general population, but a biopsy solution using 3-D UST data is still needed. Our goal is the development of a convenient, out-of-water biopsy solution for UST detected masses, which then also serves as operator independent biopsy option for the gamut of breast biopsies. The objective of this Phase I application, and the next step in pursuit of that goal, is to validate a UST-based biopsy concept for further development. With the feasibility of our new UST unit established by our extensive prior and current work, the rationale for the proposed study is that a cost-effective UST-based biopsy solution will lead to much broader commercialization of a practical, low-cost device that supports breast cancer screening and diagnosis with major societal impact for most breast biopsies. We propose to test the SoftVue biopsy system in the lab (Phase I), and then in the clinic (future Phase II application) to validate its performance and readiness for the marketplace. Building on our supportive preliminary data, we have assembled a multidisciplinary research team with the scope and breadth of expertise needed to successfully carry out the proposed work under optimal clinical and engineering environments. Delphinus Medical Technologies Inc provides a deep pool of clinical and engineering expertise with UST, while the G.E. engineering team has extensive development experience with biopsy systems.

项目概要活检能力是计划提供乳腺成像设施的绝对要求癌症筛查服务。乳房X线照相术的局限性带来了其他几种成像技术，例如磁共振（MR）、正电子发射乳房X线照相术、和乳腺特异性伽马射线，或分子乳腺成像。不过，这些都是相对而言的昂贵的方式并且需要注射对比剂，限制了它们在筛查中的潜在用途普通民众。因此，我们开发了一种更定量且更便宜的使用超声断层扫描 (UST) 原理评估乳腺肿块的方法。我们的新型商用 UST 扫描仪名为 SoftVue（Delphinus Medical Technologies），现已拥有足够的分辨率、对比度和速度来解决一般放映的负担人口，但仍然需要使用 3-D UST 数据的活检解决方案。我们的目标是开发一种方便的水外活检解决方案，用于检测 UST 肿块，然后也可以作为独立于操作员的乳腺活检选项活检。第一阶段申请的目标以及实现该目标的下一步是验证基于 UST 的活检概念以供进一步开发。随着我们新方案的可行性通过我们之前和当前的广泛工作建立了 UST 单位，拟议的理由研究表明，具有成本效益的基于 UST 的活检解决方案将带来更广泛的应用支持乳腺癌筛查的实用、低成本设备的商业化和对大多数乳腺活检具有重大社会影响的诊断。我们建议在实验室（第一阶段）测试 SoftVue 活检系统，然后在诊所（未来）第二阶段应用）以验证其性能和市场准备情况。建立在我们的支持性初步数据，我们组建了一个多学科研究团队成功开展拟议工作所需的专业知识的范围和广度最佳的临床和工程环境。 Delphinus 医疗技术公司提供 UST 拥有深厚的临床和工程专业知识，而 G.E.工程团队有丰富的活检系统开发经验。