Over the last decade, investigators at the University of Michigan (UM) have pioneered the development of diffusion-weighted MRI (DW-MRI) as an early treatment response imaging biomarker in glioma brain tumors, first in animal models and then in humans. Complex heterogeneous response patterns, typically observed in treated tumors, have led the UM team to the development of a voxel-based, analytical approach for quantification of spatially heterogeneous diffusion values referred to as the diffusion Parametric Response Map (PRMADC). Numerous laboratories have validated the use of DW-MRI for early assessment of treatment response in a variety of primary and metastatic cancer types. Nevertheless, as of today it remains confined as a research tool. For this promising technology to enter routine clinical use, a commercial application must be developed and integrated within the clinical workflow. In this grant effort, we propose to achieve this goal through the close partnership between University of Michigan (UM) and Imbio, LLC investigators. Specifically, this collaborative effort will develop a clinical grade software solution that executes PRMADC, which has been shown to provide the needed spatial and quantitative information for treatment management of cancer patients. The current effort will focus development activities for use in glioma as these data are readily available from prior NIH-funded UM trials. Thus the Specific Aims of this Fast-Track proposal will develop a commercial PRMADC software application, including product testing and data acquisition necessary for a FDA 510(k) application using images and patient information obtained from prior NIH-sponsored clinical trials. Overall, it is anticipated that the successful outcome of this effort will provide a turn-key software solution for Radiologists to longitudinally assess treatment response in patients with glioma, leading to improved patient care and a reduction in cost to the healthcare system. Importantly, the teams at UM and Imbio have a very successful track record of collaboration, with already one FDA-cleared PRM application for lung CT imaging which is now available for commercial sale in the USA, Europe and Canada.
As of today, diagnosing the early response to treatment in certain brain tumors (called gliomas) has been a challenging task, in part because of the spatial heterogeneity of the response across the tumor. Current methodologies rely on averaging parameters of response across the entire tumor, thereby losing important spatial information. With this work we will develop software based on a technology that spatially ?maps? the tumor?s response, and that has demonstrated a higher sensitivity when measuring the early response to treatment.
