Virtual Bone Biopsy: Transfer to the clinical arena

虚拟骨活检：转移到临床领域

• 批准号: 6830579
• 负责人: Michael KLEEREKOPER
• 金额: $ 19.89万
• 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 2005-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6830579
• 关键词: bioimaging /biomedical imaging; biopsy; bone density; bone disorder; bone imaging /visualization /scanning; clinical research; computer program /software; densitometry; human subject; magnetic resonance imaging; noninvasive diagnosis; osteoporosis; technology /technique development; bioimaging /biomedical imaging; biopsy; bone density; bone disorder; bone imaging /visualization /scanning; clinical research; computer program /software; densitometry; human subject; magnetic resonance imaging; noninvasive diagnosis; osteoporosis; technology /technique development

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，存在几种有效的FDA批准疗法，但在很大程度上未被诊断和未经治疗。虽然使用双能X射线吸收法（DXA）的骨密度测定法是骨质疏松症诊断的当前“金标准”，但对照临床试验强调了其在个别患者水平上的敏感性和特异性限制。最近的研究表明，小梁网络结构对有助于骨骼强度的完整性的重要性。到目前为止，只有在体外研究是可能的，通常是从丁香峰收获的活检。 虚拟骨活检（VBB）是一种微型MRI技术，已被证明可在骨骼质量上获得骨骼结构的3D图像，并提供了评估体内骨骼强度的平台。它由图像采集和处理软件以及增加临床MRI扫描仪的硬件组件组成。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来监测和直接在单个水平上进行治疗。 这项快速曲目的建议旨在使用在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序列评估。 该SBIR快速提案的第一阶段的总体目标是检查VBB系统功能的可行性，到目前为止，这些功能仅在Inventors的实验室中得到证明，该实验室由Felix W. Wehrli博士执导。 为了记录可以在配备GE 1.5 Tesla MR Scanners的任何站点可靠地部署VBB Micromri将追求以下目标： 1。评估商业制造的硬件定制以进行标准化的性能。 2。将VBB安装在第二个研究站点并评估其性能。 这些验证方法将证明可以将VBB从学术环境转移到临床领域的假设，这是该系统商业化途径及其最终采用临床实践的第一步。