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

项目总结 活检能力是计划提供乳房的成像设施的绝对要求 癌症筛查服务。乳房X光检查的局限性也带来了其他几个 成像技术，如磁共振(MR)、正电子发射乳房X光照相、 和乳房特异伽马，或分子乳房成像。然而，这些都是相对的。 昂贵的方式和需要对比剂注射，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、更便宜的 使用超声断层扫描(UST)原理评估乳腺肿块的方法。 我们新的商用UST扫描仪名为SoftVue(Delphinus Medical Technologies)，现在具有 足够的分辨率、对比度和速度来解决一般筛查的负担 人口，但仍然需要使用三维UST数据的活检解决方案。 我们的目标是开发一种方便的、离水的UST检测活检解决方案 肿块，然后还充当操作员独立的乳房色域活检选项 活组织检查。此第一阶段应用程序的目标，以及追求该目标的下一步，是 验证基于UST的活组织检查概念以进行进一步开发。随着我们新的 科大单位成立的依据是我们广泛的前期工作和当前的工作，提出了 研究表明，经济高效的基于UST的活检解决方案将导致更广泛的 支持乳腺癌筛查和治疗的实用、低成本设备的商业化 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活组织检查系统，然后在临床(未来 第二阶段应用)，以验证其性能和市场准备情况。在基础上建设 我们的支持性初步数据，我们已经组建了一个多学科的研究团队， 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 Medical Technologies Inc.提供 科大拥有丰富的临床和工程专业知识，而通用电气工程团队 具有丰富的活组织检查系统开发经验。

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.