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

• 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
• 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

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.

项目摘要 活检能力是计划为乳腺癌患者提供乳房活检的成像设施的绝对要求。 癌症筛查服务。乳房X光检查的局限性带来了其他几个 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。但是，这些都是相对 昂贵的方式和需要对比剂注射，限制了它们用于筛查的潜在用途， 一般人。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。 我们新的商业UST扫描仪，名为SoftVue（Delphinus Medical Technologies），现在 足够的分辨率、对比度和速度，以解决一般 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、非水活检解决方案，用于检测UST。 肿块，然后也作为操作员独立的活检选项，用于乳房的所有区域 活组织检查第一阶段申请的目标以及实现这一目标的下一步是 验证基于UST的活检概念，以便进一步发展。随着我们新的可行性 通过我们以前和现在广泛的工作建立了UST单元，提出了 一项研究表明，具有成本效益的基于UST的活检解决方案将导致更广泛的 商业化的实用，低成本的设备，支持乳腺癌筛查， 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）和临床（未来）测试SoftVue活检系统 第二阶段的应用），以验证其性能和市场准备。基础上 我们的初步数据支持，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门知识的范围和广度 最佳的临床和工程环境。Delphinus Medical Technologies Inc提供 UST拥有深厚的临床和工程专业知识，而GE工程技术团队拥有 拥有丰富的活检系统开发经验。