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.
