CLARIX IMAGING CORP — Department of Health and Human Services SBIR Phase I: 102

Description

Abstract Clarix Imaging CorporationClarixis focused on solving one of the largest problems in early stage breast cancer treatmentreoperations for positive marginsAboutof the andgtpatients who undergo lumpectomy in the US each year will face this additional procedure because current options for identifying positive margins intraoperatively are insufficientCurrently physicians rely onD specimen imaging for assessing margin status during surgery which cannot adequately represent theD margin morphologyThereforeClarix is developing a novel volumetric specimen imagerVSIdevice that yields fullyD images of the specimen with isotropic resolution which can significantly improve margin assessment and provide precise guidance for immediate re excision before closing woundWe have previously demonstrated the ability of our VSI patented algorithms to overcome long scan times of conventionalD imagers that would disrupt surgical workflowand are now proposing development of a novelalgorithm enabled spectral VSI system to further differentiate cancerous from healthy tissueRecent developments by our founders allow for spectral CT with no special hardwareThe addition of spectral imaging to our VSI system will enable automated cancer delineation in margin assessment improving surgical accuracy and pathologic assessmentand can also be applied to in vivo breast imagingIn the Phase I project we set out to demonstrate proof of concept of differentiation between breast tumors and healthy tissue using spectral image reconstruction tailored to VSIThe Specific Aims are tocreate and validate simulated spectral VSI data of breast cancer specimensverify the robustness of the spectral VSI algorithm for breast cancer specimensandverify that spectral VSI can enable breast tumor delineation in patient specimensReaching the above Aims will firmly establish the feasibility of spectral CT for cancer differentiation further establishing Clarix VSI as the technical leader in the fast growing specimen imaging market Project Narrative Women who undergo lumpectomy for breast cancer have close to ainchance of needing a repeat operation because cancer was left in their breastProviding surgeons with imaging tools in the operating room can increase rates of complete cancer removal in the first surgeryD mammograms of surgical specimens can already be taken in the operating roombut overlying tissue in aD image commonly masks the tumorClarix Imaging Corporation is developingD CT Volumetric Specimen ImagerVSIto address these challenges providing surgeons with more actionable informationThe focus of this project is to incorporate spectral imaging into the VSI to allow for increased differentiation between cancerous and healthy tissues