InseRT — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant Significance Accurate targeting guidance and monitoring of interventional therapy in the brain are critical for maximizing their effectiveness and safety during and following neurosurgical procedures Magnetic resonance imaging MRI is a critical tool for planning and guiding neurosurgical procedures In most cases the MRI is obtained during a pre operative session however either brain shift errors in device guidance or device malfunction can lead to poor outcomes In particular for infusion based therapies the location of the infusion cannula in the brain the difficulty of predicting how agents will distribte through the complex nature of brain tumors and loss of the therapeutic agent through backflow or other mechanisms may significantly influence the therapeutic outcome The inseRT MRI system provides a unique solution for providing real time interactive brain imaging for drug infusion procedures by providing a workflow environment that is intuitive for neurosurgeons Phase I Progress A successful model for iteratively developing testing accessing and revising our platform based on rapid customer feedback has been implemented during Phase I The platform was used to successfully guide and monitor gene delivery into survival NHP models in a protocol demanding more precision than human protocols Specific Aims of Phase II This project will further develop the inseRT MRI system as a commercial product for image guided drug infusion procedures In Specific Aim the inseRT MRI platform interface will add the remaining features our collaborators in Neurosurgery are requesting for a simplified methodical workflow that is similar to the stereotactic procedures used in operating rooms today The technology will be evaluated by neurosurgeons to demonstrate localization of targeting within mm in gel phantoms and cadaver heads In Specific Aim predictive models of drug infusion distribution used only in surgical planning today will be integrated into the inseRT MRI system Real time quantitative drug tracer information from the infusion in progress will be used to improve the algorithmandapos s ability to demonstrate the most likely final drug distribution to the surgeon This information can be used by the surgeon to alter the infusion to meet the treatment goals during surgery Quantitative infusion concentration results will be tested against non real time measurement techniques In Specific Aim the inseRT MRI system with improved interface and predictive drug distribution modeling will be evaluated in animal models These studies are designed as inputs for upcoming FDA IDE and k submissions PUBLIC HEALTH RELEVANCE The ultimate goal of this project is to develop a commercial workstation platform for guiding brain surgeries inside of an MRI scanner The initial goal develops a specific application speeding and simplifying MR guided drug delivery A scanner independent platform obtains control of the scanner that allows us to build all the necessary imaging tasks needed for drug delivery which are now scattered across several different computer interfaces The proposal adds two innovations First the system enables the surgeon to dynamically interact with both the imaging system and the device to optimize device positioning and therapeutic monitoring Second the platform will predict the spatial distribution of drugs that are infused in the brain The completed project will provide a platform for image guided drug delivery trials in patients