Virtual Bone Biopsy: Transfer to the clinical arena

虚拟骨活检：转移到临床领域

• 批准号: 7284856
• 负责人: Michael KLEEREKOPER
• 金额: $ 88.03万
• 依托单位: MICROMRI, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-20 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7284856
• 关键词: Adoption; Architecture; Benchmarking; Biopsy; Bone Diseases; Clinical; Community Health; Competence; Computer software; Controlled Clinical Trials; Data; Data Analyses; Densitometry; Devices; Diagnosis; Distal; Doctor of Medicine; Doctor of Philosophy; Future; Goals; Gold; Harvest; Housing; Image; Immobilization; In Vitro; Individual; Institution; Laboratories; Location; Magnetic Resonance Imaging; Measures; Medical; Medicine; Methods; Monitor; Osteoporosis; Outsourcing; Pathway interactions; Patients; Pennsylvania; Performance; Phase; Philadelphia; Process; RF coil; Radial; Radiology Specialty; Reproducibility; Research; Research Personnel; Resources; Scanning; Sensitivity and Specificity; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Structure; System; Technology; Testing; Three-Dimensional Image; Three-Dimensional Imaging; United States Food and Drug Administration; Universities; Validation; Washington; Work; base; bone; bone strength; clinical research site; commercialization; cost; design; design and construction; experience; healthy volunteer; in vivo; professor; programs; prototype; radius bone structure; response; validation studies; virtual; volunteer

Osteoporosis is a major community health problem for which several effective FDA approved therapies exist, but which remains largely undiagnosed and untreated. While bone densitometry using dual-energy x-ray absorptiometry (DXA) is the current "gold standard" in osteoporosis diagnosis, controlled clinical trials have highlighted its sensitivity and specificity limitations at the individual patient level. Recent research demonstrated the significance of the integrity of the structure of the trabecular network in contributing to bone strength. Up to now, only in vitro research was possible, typically biopsies harvested from the lilac crest. The Virtual Bone Biopsy (VBB) is a micro-MRI technology that has been demonstrated to obtain 3D images of bone architecture in addition to bone mass and provides a platform for assessing bone strength in vivo. It is comprised of image acquisition and processing software and hardware components that augment clinical MRI scanners. Preliminary studies indicate that MRI-derived topology parameters may have the necessary sensitivity and specificity to monitor and direct treatment at the individual level. This Fast-Track proposal aims to conduct the first serial assessment of bone competence and therapy response using topological parameters obtained non-invasively in vivo. The overall goal of Phase I of this SBIR Fast Track proposal is to examine the feasibility of the VBB system capabilities that, until now, have only been demonstrated in the inventors' laboratory, directed by Dr. Felix W. Wehrli. In order to document that VBB can be reliably deployed at any site equipped with GE 1.5 tesla MR scanners MicroMRI will pursue the following aims: 1. Evaluate commercially manufactured hardware customized for standardized performance. 2. Install the VBB at an second study site and evaluate its performance. These validation methods will prove the hypothesis that the VBB can viably be transferred from the academic setting into the clinical arena, as a first step in the pathway to commercialization of the system, and its eventual adoption into clinical practice.

骨质疏松症是一个主要的社区健康问题，FDA 批准了几种有效的治疗方法，但该问题在很大程度上仍未得到诊断和治疗。虽然使用双能 X 射线骨密度测定 (DXA) 的骨密度测定是当前骨质疏松症诊断的“金标准”，但对照临床试验强调了其在个体患者水平上的敏感性和特异性限制。最近的研究证明了小梁网络结构的完整性对骨强度的重要性。到目前为止，只能进行体外研究，通常是从紫丁香嵴采集的活组织检查。 虚拟骨活检 (VBB) 是一种微型 MRI 技术，已被证明可以获得除骨量之外的骨结构的 3D 图像，并为评估体内骨强度提供平台。它由图像采集和处理软件以及硬件组件组成，可增强临床 MRI 扫描仪的功能。初步研究表明，MRI 衍生的拓扑参数可能具有必要的敏感性和特异性，可以在个体水平上监测和指导治疗。 该快速通道提案旨在利用体内非侵入性获得的拓扑参数对骨能力和治疗反应进行首次系列评估。 SBIR 快速通道提案第一阶段的总体目标是检查 VBB 系统功能的可行性，迄今为止，该系统功能仅在 Felix W. Wehrli 博士指导下的发明人实验室中进行了演示。 为了证明 VBB 可以可靠地部署在任何配备 GE 1.5 特斯拉 MR 扫描仪的站点 MicroMRI 将追求以下目标： 1. 评估为标准化性能定制的商业制造硬件。 2. 在第二个研究地点安装 VBB 并评估其性能。 这些验证方法将证明 VBB 可以从学术环境转移到临床领域的假设，作为系统商业化及其最终采用临床实践的第一步。