Development of Parametric Response Mapping Software for Clinical Cancer Response Assessment

Over the last decadeinvestigators at the University of MichiganUMhave pioneered the development of diffusion weighted MRIDW MRIas an early treatment response imaging biomarker in glioma brain tumorsfirst in animal models and then in humansComplex heterogeneous response patternstypically observed in treated tumorshave led the UM team to the development of a voxel basedanalytical approach for quantification of spatially heterogeneous diffusion values referred to as the diffusion Parametric Response MapPRMADCNumerous laboratories have validated the use of DW MRI for early assessment of treatment response in a variety of primary and metastatic cancer typesNeverthelessas of today it remains confined as a research toolFor this promising technology to enter routine clinical usea commercial application must be developed and integrated within the clinical workflowIn this grant effortwe propose to achieve this goal through the close partnership between University of MichiganUMand ImbioLLC investigatorsSpecificallythis collaborative effort will develop a clinical grade software solution that executes PRMADCwhich has been shown to provide the needed spatial and quantitative information for treatment management of cancer patientsThe current effort will focus development activities for use in glioma as these data are readily available from prior NIH funded UM trialsThus the Specific Aims of this Fast Track proposal will develop a commercial PRMADC software applicationincluding product testing and data acquisition necessary for a FDAkapplication using images and patient information obtained from prior NIH sponsored clinical trialsOverallit 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 gliomaleading to improved patient care and a reduction in cost to the healthcare systemImportantlythe teams at UM and Imbio have a very successful track record of collaborationwith already one FDA cleared PRM application for lung CT imaging which is now available for commercial sale in the USAEurope and Canada As of todaydiagnosing the early response to treatment in certain brain tumorscalled gliomashas been a challenging taskin part because of the spatial heterogeneity of the response across the tumorCurrent methodologies rely on averaging parameters of response across the entire tumorthereby losing important spatial informationWith this work we will develop software based on a technology that spatiallymapsthe tumor s responseand that has demonstrated a higher sensitivity when measuring the early response to treatment