Development of a Wearable Fluorescence Imaging Device for Intraoperative Identification of Brain Tumors

ABSTRACTApproximatelypeople in the United States have been diagnosed with a primary brain tumorOf thesemalignant gliomasMGsaccount for approximatelyof all intracranial tumorswith an overall patient survival rate of onlyMore than any other cancerbrain cancer has lasting physicalcognitiveand psychological impacts on a patient s lifeand the highest per patient initial cost of careSurgical resection remains the cornerstone of therapy and the extent of resection correlates with patient survivalA limiting factor for resectionhoweveris the surgeon s ability to differentiate the tumor from normal tissueIn pursuit of intraoperative guidance for the safe and maximal resectionfluorescence guided surgery has emerged as an advanced adjunctive techniqueThe uses of surgical operative microscopes with FDA approved fluorescein dye have shown significantly higher tumor resection ratesin MGs than conventional surgeriesHowevermost clinical grade fluorescence microscopese gPENTEROmicroscope with YELLOWfluorescein moduleCarl Zeiss Meditec AGare hampered by high costs$Klimited portabilitylbsand lack of operation flexibilityMany surgeons preferand continue to use wearable surgical eye loupeswhich allow for convenient and fast operationbut are not capable of fluorescence visualizationTo overcome limitations of currently available surgical imaging techniqueswe have preliminarily demonstrated safety and feasibility of an innovative wearable fluorescence prototype that piggybacks on eye loupes for identifying MGsPending PatentPCT USIn this Phase I studywe will collaborate with a startup companyBioptics TechnologyLLCto miniaturizeoptimizeand validate this low cost device$ Kwith user experiencee gease of wearingalignmentand operationfor easy and accurate fluorescent identification of MGs during resectionCompact LEDs and a small CMOS camera with dedicated optical filters will be optically integrated into different functional modules for florescence excitation and detectionThese lightweightcompactand inexpensive modules will be attached to the eye loupes to form an integrated wearable deviceallowing for real time ocular observation and video recording of fluorescence and color imagesThe device operating system will be optimized to beup and runningso that neurosurgeons can easily use it without much specialized trainingTo ensure appropriate performance and sufficient accuracythis device will be first optimized and calibrated using tumor simulating phantoms against the PENTEROmicroscope with YELLOWAimand then validated in patients with MGs against histopathological analyses of biopsied samples taken from the surgical tumor marginAimThe potential market size of this device would be tens of millions of dollars in the US aloneproviding a significant opportunity for commercializationUltimatelythis affordablewearableand ergonomic device will significantly increase the ability of more surgeons to conduct fast and thorough operationsand thus improve surgical outcomes and reduce the burden on healthcare systems PROJECT NARRATIVE The goal of this STTR Phase I project is to develop and commercialize an innovative low costwearablefluorescence imaging device that can be attached to the standard surgical eye loupes for helping neurosurgeons to easily and accurately identify brain tumors for safe and maximal resectionThis wearable ergonomic device will result in a wide range of movement and fast easy operationthus providing a novel way to image fluorescing brain tumors without a large expensive operative microscopeThe potential market size of this affordable device are tens of millions of dollars in the US aloneand potential customers are neurosurgeons working across a wide range of surgical unitsespecially at regional and mobile army surgical hospitals