Bio-Effects of Ultra-High MRI Gradient Slew Rates

超高 MRI 梯度转换率的生物效应

• 批准号: 8059465
• 负责人: STANLEY THOMAS FRICKE
• 金额: $ 82.33万
• 依托单位: WEINBERG MEDICAL PHYSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-01 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8059465
• 关键词: 3-Dimensional; Achievement; Acoustic Stimulation; Acoustics; Adoption; Adult; Animals; Brain; Brain imaging; Capital; Childhood; Clinical; Clinical Research; Clinical Trials; Collection; Commit; Computer software; Country; Development; Devices; Diagnostic; Diffusion Magnetic Resonance Imaging; Ear; Equipment; Exposure to; Fiber; Frequencies; Functional Magnetic Resonance Imaging; Goals; Health Care Costs; Human; Human Volunteers; Image; Imagery; Imaging Phantoms; Institutional Review Boards; Isotropy; Knowledge; Lead; Life; Loudness; Magnetic Resonance Imaging; Magnetism; Measures; Medical; Medical Technology; Morphologic artifacts; Motion; Motivation; Nerve; Nervous system structure; Neurologic; Noise; Optic Nerve; Pain; Patients; Performance; Phase; Physics; Physiologic pulse; Polyesters; Publishing; Relaxation; Research Personnel; Resolution; Sampling; Scanning; Sedation procedure; Signal Transduction; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Speed; Structure; Swimming; System; Techniques; Technology; Testing; Time; United States National Institutes of Health; Vertebrates; Water; Width; Work; Zebrafish; base; high standard; human tissue; image visualization; improved; in vivo; magnetic field; meter; millimeter; multidisciplinary; new technology; novel; operation; programs; radiologist; sample fixation; software development; white matter

DESCRIPTION (provided by applicant): This application represents a competing renewal request for a Phase II STTR project, in which we constructed an ultra-fast gradient system for magnetic resonance imaging. Operation of the novel system is based upon the principle that the nervous system is relatively insensitive to very short exposures to changing magnetic fields. As a result, we are showing in clinical trials that magnetic slew rates (i.e., changes in gradients per time) can be 1,000 times faster than are currently available in clinical MRI scanners, and deliver magnetic gradients 10 times higher, without painful stimulation. The purpose of this competing renewal is to take the technology to the level of FDA approval. Based on well-established principles of MRI physics, it stands to reason that the increased gradient strength and shorter pulse sequences permitted by the new technology will have multiple meaningful benefits to users of clinical and research systems, including overall decreased acquisition time, reduction in acoustic noise, and elimination of artifacts due to subject motion. The multidisciplinary team assembled for this project includes MRI physicists, pediatric and general radiologists, and neuroscientists, experts in pulsed power technology, medical capital equipment entrepreneurs, and committed technical representatives of potential strategic partners active in this field. The team has worked well together over the past five years to achieve significant achievements, and has collaborated in the past to launch four medical products with the aid of the NIH SBIR program. Milestones to be accomplished in this project include adaptation of the system to a 7-Tesla animal MRI scanner and a clinical 3-Tesla system, visualization of post-mortem human tissues and moving vertebrate animals, FDA-mandated human trials of nervous stimulation and acoustic noise, and high- resolution tractography and functional MRI of the human brain in vivo. From a commercial point of view, configuring the product as a replacement upgrade to existing MRI systems has been a very successful financial strategy for several companies, one of which has committed to assisting us in this effort. Potential benefits to the country include health-care cost reduction (as a result of reduced scan-times per patient), increased scientific knowledge and diagnostic confidence as we examine smaller features of the nervous system, export potential of advanced medical products, and improved patient comfort (as we reduce acoustic noise and the need for sedation of pediatric and adult subjects). PUBLIC HEALTH RELEVANCE: Potential benefits to the country include health-care cost reduction (as a result of reduced scan- times per patient), increased scientific knowledge and diagnostic confidence as we examine smaller features of the nervous system, export potential of advanced medical products, and improved patient comfort (as we reduce acoustic noise and the need for sedation of pediatric and adult subjects).

描述（由申请人提供）：本申请代表了第二阶段 STTR 项目的竞争性更新请求，在该项目中，我们构建了用于磁共振成像的超快梯度系统。该新颖系统的操作基于这样的原理：神经系统对于非常短时间暴露于变化的磁场相对不敏感。因此，我们在临床试验中表明，磁转换速率（即每次梯度变化）可以比目前临床 MRI 扫描仪快 1,000 倍，并提供高出 10 倍的磁梯度，且不会产生痛苦的刺激。此次竞争性更新的目的是使该技术达到 FDA 批准的水平。基于 MRI 物理学的既定原理，新技术允许增加的梯度强度和更短的脉冲序列将为临床和研究系统的用户带来多种有意义的好处，包括总体采集时间的缩短、声学信号的减少，这是理所当然的。噪声，并消除由于主体运动而产生的伪影。为该项目组建的多学科团队包括 MRI 物理学家、儿科和普通放射科医生、神经科学家、脉冲功率技术专家、医疗资本设备企业家以及活跃在该领域的潜在战略合作伙伴的技术代表。该团队在过去五年中通力合作，取得了重大成就，并在 NIH SBIR 项目的帮助下合作推出了四种医疗产品。该项目要实现的里程碑包括使系统适应 7-Tesla 动物 MRI 扫描仪和临床 3-Tesla 系统、尸检人体组织和移动脊椎动物的可视化、FDA 授权的神经刺激和声学人体试验噪声、人脑体内高分辨率纤维束成像和功能性 MRI。从商业角度来看，将该产品配置为现有 MRI 系统的替代升级对于多家公司来说是一项非常成功的财务策略，其中一家公司已承诺协助我们开展这项工作。对该国的潜在好处包括降低医疗保健成本（由于每个患者的扫描时间减少）、随着我们检查神经系统的较小特征而增加科学知识和诊断信心、先进医疗产品的出口潜力以及改善患者状况舒适度（因为我们减少了噪音以及儿科和成人受试者的镇静需求）。 公共健康相关性：对国家的潜在好处包括降低医疗成本（由于每个患者的扫描时间减少）、在检查神经系统的较小特征时增加科学知识和诊断信心、先进医疗产品的出口潜力，并提高患者的舒适度（因为我们减少了噪音以及儿科和成人受试者的镇静需求）。