HyperE — Department of Health and Human Services SBIR Phase I: 102

Description

PROJECT SUMMARY Our Small Business Innovation Research initiative is focused on offering novelcost effective clinical equipment and techniques that significantly impact and advance diagnostics and therapeutic monitoring of a variety of cancersHyperE proposes to design and produce the first commercial ready parahydrogen induced polarizationPHIPinstrument to facilitate the breakthrough of PHIPan emerging enhanced MRI technique with major clinical potential for molecular imaging with new generation agentsIn conjunction with MRIPHIP amplifies the inherently low MRI signal enabling in vivo molecular imaging supported by hyperpolarized molecules that inform cellular composition and metabolismcritical factors for identification and tracking of cancer tissueCommercial PHIP equipment to be coupled with MRI is not available at presentSo farexploration of this promising yet complex technology has been limited to a handful hyperpolarization MRI research experts with the technical skill and facility to construct their own equipmentOur custom built polarizer prototype at CedarsSinai has proven to set the benchmark in performance and resulted in valuable published PHIP experimental insightUpon implementation of our innovative new designthe proposed instrument is not only expected to be state of the art in functionalityflexibilityaffordabilityand usabilitybut also meet feasibility criteria for clinical use via access to new hyperpolarized moleculesOur HyperE Phase I proposal aims to produce turn key research equipment for studying new metabolism and molecular targeting agents to better detectcharacterize and track changes in cancerAimof phase IBuild the first commercial ready homogeneous heterogeneous catalyst PHIP polarizer for research labs that reliably produces andgtpolarizationRationalea universal PHIP polarizer for multiple catalyst schemes is a completely new technology for basic scienceas well as preclinical researchAimof phase IValidate the polarizer functionality through comparison of the prototype design visvis the proposed two chamber design to assess hydrogenation performance and carbon polarization transferRationalesetting the framework for optimal carbon polarizationas well as precise comparative performance analysis will confirm the impact of the improved homogeneous magnetic field designThe ultimate goalproposal phases II and IIIis to evolve the design to commercially fabricate and provide a marketable product for under $k for clinical utilizationWe envision that our instrument design will not only represent a technological research innovation but open up completely new clinical imaging possibilities not available with current medical practice toolsThis polarizer is projected to propel MRI combined with PHIP to play a major role in cancer detection and treatment controladdressing unmet needs and joining the ranks of PET and CT PROJECT NARRATIVE Molecular imaging advancement for diagnosis and treatment planning of cancer represents a top clinical priorityTo support breakthrough of parahydrogen induced polarizationPHIPa promising hyperpolarized MRI technique that can fill critical gaps in the current diagnostics and therapy response imaging toolsetHyperE proposes to build an innovative PHIP instrument uniquely designed to overcome current barriers for clinical applicationThe proposed instrument is expected to not only surpass all documented custom built PHIP research polarizers but to mark commercialization readinessa first in the PHIP field