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

DESCRIPTION (provided by applicant): MicroMRI, Inc. Development of a cost-effective pfMRI 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 gol d standard , dual-energy x-ray absorptiometry (DXA), cannot assess bone quality and fails to detect gt 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 (fMRI). 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 MR I 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 fMRI is an important complement to DXA. While DXA re mains the tool for diagnosis of osteoporosis for the foreseeable future, fMRI 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 phy sician's office, not hospitals. Appropriately, the majority of DXAs are currently located in out-patient settings. To fully capitalize on the promise of fMRI 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 pfMRI to remain in line with peripheral devices for studying the skeleton, using methods that exp ose 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 feasibi lity of developing a technology which can produce high resolution images of similar quality as its existing fMRI 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 pfM RI, 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 fMRI method. Once the se activities are completed, MicroMRI will use non-grant funds to complete the commercialization and product launch of the stand-alone scanner.