InseRT — Department of Health and Human Services SBIR Phase I: 105

Description

SignificanceWe propose to extend and customize inseRT MRI s Real Time MR image guided surgical platformoriginally developed for cerebral biopsy and direct injection cancer therapiesto overcome shortcomings in CT guidance of a promising new thrombolytic therapy for intracerebral hemorrhageICHICH is a devastating injury creating stroke like outcomes inpeople in the USA each yearDamage from mechanical effects of the blood clot in the brain is followed by damage due to exposure to decaying blood products and edemawith little promise of rehabilitation afterwards for surviving victimsMinimal Invasive SurgeryMISapproaches can dissolve blood clots by delivering recombinant tissue type plasminogen activatorrtPAdirectly into clots through rigid catheter insertionsand have shown significant promise in NIH Phase I and II TrialsThese Trials have reduced long term neurological deficits by removing significant portions of the clots with few procedure related side effectsHoweverthe extent of clot reduction and thus treatment benefits vary significantly between patients due to lack of monitoring technology to guide clot removal while maintaining a desirable safety profileIn current practicea catheter is placed into the deep end of the clot using stereotactic guidancertPA is administered in moderateuniform dosesmlapproximately everyhours as the portion of the clot that dissolves is allowed to drainThe treatment is iterated up totimes overdaysCT images are currently acquired periodically to monitor gross clot sizedepicted as an iso intense region in CTWithout knowledge of where the rtPA is distributedthe patient must be dosed conservatively to avoid a re hemorrhageWe have recognized how our expertise in MR guided brain infusions can drive the drug further into the clot while monitoring its spatial distributionThis advance will reduce the number iterationsultimately to a single iterationwhile reducing outcome variations and maintaining safetyGoalsWe will create an kitted solution of guideportscathetersand corresponding guidance and monitoring software for ICH evacuationWe will exploit MRI s ability to differentiate clot components to immediately extract plasma during catheter placement to minimize secondary brain damageWe will then translate the use of infusion cathetersdesigned first for brain cancer infusionsto drive clot busting drugs safely over a much larger distribution zone byD visualization of rtPA distribution within the clotThe new application will exploit inseRT MRI s ability to control MRI scanner image acquisition and visualize infusion feedback in true real time while eliminating the complexity of using a diagnostic MR scanner for an interventional application!Recent image guided therapies have shown the capability to reduce the clot volumebrain edemaand thus long term neurological problems suffered by strokes started by a brain bleedBut as computed tomographyCTthe current method of guiding clot busting drugs into the clotdoesn t permit the surgeon to visualize the changing makeup of the clot or map where clot busting drugs are goingsurgeons are limited to following conservative treatment rulesAs magnetic resonanceMRimaging does not have these weaknesseswe propose to empower surgeons to remove more of the clot in less time by adapting our Real time MR guidance platform and novel cathetersWe will dissolve the clot faster while maintaining safety by visualizing where clot busting drugs are moving in the clot