Development of a cost-effective pmMRI for in vivo structural examination of bone

开发用于骨体内结构检查的经济有效的 pmMRI

• 批准号: 7326608
• 负责人: Michael KLEEREKOPER
• 金额: $ 11.32万
• 依托单位: MICROMRI, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7326608
• 关键词: Address; Adopted; Anatomy; Ankle; Appendix; Architecture; Benchmarking; Biopsy; Bone Density; Bone Diseases; Clinic; Clinical; Coin; Collaborations; Complement; Computer software; Computers; Data; Development; Devices; Diagnosis; Disease Progression; Distal; Electronics; Enrollment; Environment; Equipment; Fracture; Frequencies; Funding; Future; Goals; Gold; Grant; Hospitals; Human; Image; Immobilization; Individual; Investigation; Ionizing radiation; Joints; Laboratory Research; Limb structure; Magnetic Resonance; Magnetic Resonance Imaging; Marrow; Measurement; Measures; Methods; Microscopic; Modality; Monitor; New Mexico; Osteoporosis; Outpatients; Patients; Performance; Peripheral; Persons; Phase; Physicians; Physicians' Offices; Physiologic pulse; Prevalence; Progress Reports; Property; Pulse taking; Radio; Reproducibility; Research Proposals; Resolution; Risk; Safety; Scanning; Secure; Skeleton; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Specific qualifier value; Standards of Weights and Measures; Structure; Study Section; System; Systems Analysis; Technology; Testing; Time; TimeLine; Variant; Weight; Wrist; Writing; abstracting; bone; bone quality; commercialization; computerized data processing; cost; design; human subject; in vivo; magnetic field; new technology; novel strategies; point of care; prototype; radius bone structure; research study; response; size; tool; usability; virtual

DESCRIPTION (provided by applicant): MicroMRI, Inc. Development of a cost-effective p¿MRI for in vivo structural examination of bone Abstract Osteoporosis is a systemic bone disease characterized by low bone mass and abnormal bone quality. The current "gold standard", dual-energy x-ray absorptiometry (DXA), cannot assess bone quality and fails to detect > 50% of persons at greatest risk of fracture. MicroMRI is refining a new approach to non-invasively assess the micro- structural aspects of bone quality, at the wrist and ankle, using high-resolution magnetic resonance imaging (¿MRI). Previously, this technology was coined "Virtual Bone Biopsy" by its inventor, Dr. Felix Wehrli. Our preliminary studies using coils that are "add-ons" to standard full-body MRI equipment indicate that bone structure parameters we determine have the necessary properties to monitor and direct appropriate treatment at the individual patient level. Thus, the company believes that ¿MRI is an important complement to DXA. While DXA remains the tool for diagnosis of osteoporosis for the foreseeable future, ¿MRI will be the tool of choice to measure disease progression and assess therapy response. The prevalence of osteoporosis requires that its diagnosis and monitoring remain at the physician's office, not hospitals. Appropriately, the majority of DXAs are currently located in out-patient settings. To fully capitalize on the promise of ¿MRI of bone, this technology should also be at the point-of-care in physicians' offices. In this grant, we are proposing to develop a cost-effective stand-alone MRI system for extremity measurement in the PCP setting. We have termed the proposed new technology p¿MRI to remain in line with peripheral devices for studying the skeleton, using methods that expose the patient to ionizing radiation (pDXA, pQCT), . Extremity MRI scanners are already available for purchase but are either low-cost with low-resolution, or very expensive with high-resolution. In Phase I of this proposal, MicroMRI will test the feasibility of developing a technology which can produce high resolution images of similar quality as its existing ¿MRI system, yet cost-effective enough to be adopted by physician groups and in private clinics. In Phase II, we will develop a prototype of the p¿MRI, and perform safety and efficacy tests. We will optimize this prototype, conduct accuracy and reproducibility measurements to establish that the data obtained are identical (within acceptable, pre- specified limits) to our existing ¿MRI method. Once these activities are completed, MicroMRI will use non-grant funds to complete the commercialization and product launch of the stand-alone scanner.

描述（由申请人提供）：MicroMRI, Inc. 开发具有成本效益的 p¿摘要 骨质疏松症是一种以骨量低、骨质量异常为特征的全身性骨病，目前的“金标准”双能X线骨密度仪（DXA）无法评估骨质量，也无法评估骨质量。 MicroMRI 正在完善一种新方法，利用高分辨率磁共振成像来非侵入性地评估腕部和脚踝处骨质量的微观结构。 (¿MRI) 此前，这项技术被其发明者 Felix Wehrli 博士创造为“虚拟骨活检”。我们使用作为标准全身 MRI 设备“附加”的线圈进行的初步研究表明，我们可以利用线圈来确定骨骼结构参数。确定具有必要的属性来监测和指导针对个体患者的适当治疗因此，该公司认为 ¿ MRI 是 DXA 的重要补充，而在可预见的将来 DXA 仍然是诊断骨质疏松症的工具。 MRI 将成为衡量疾病进展和评估治疗反应的首选工具。骨质疏松症的患病率要求其诊断和监测必须在医生办公室进行，而不是在医院进行。目前，大多数 DXA 都在门诊进行。充分利用 ¿骨 MRI，这项技术也应该应用于医生办公室的护理点。在这项拨款中，我们建议开发一种经济有效的独立 MRI 系统，用于 PCP 环境中的四肢测量。拟议的新技术 p¿ MRI 与用于研究骨骼的外围设备保持一致，使用将患者暴露于电离辐射（pDXA、pQCT）的方法，肢体 MRI 扫描仪已经可以购买，但要么成本低、分辨率低，要么非常低。在该提案的第一阶段，MicroMRI 将测试开发一种能够产生与现有质量类似的高分辨率图像的技术的可行性。 MRI 系统，但具有足够的成本效益，足以被医生团体和私人诊所采用。在第二阶段，我们将开发 p¿ MRI，并进行安全性和有效性测试，我们将优化该原型，进行准确性和再现性测量，以确定获得的数据与我们现有的数据相同（在可接受的、预先指定的限度内）。一旦这些活动完成，MicroMRI 将使用非赠款资金来完成独立扫描仪的商业化和产品发布。