Real-time volumetric specimen imager for 3D intra-operative lumpectomy margin assessment

DESCRIPTION provided by applicant We propose to develop a novel volumetric specimen imager VSI device for significantly reducing breast lumpectomyandapos s reoperation rate and improving outcomes Among the annual performance of andgt lumpectomies in the US up to of patients need a reoperation when post surgery pathology examination reveals andquot positive marginandquot indicating incomplete tumor removal Currently physicians rely on D specimen imaging for assessing margin status during surgery which cannot adequately represent the D margin morphology We propose a next generation VSI device that yields fully D images of the specimen with isotropic resolution which can significantly improve margin assessment and provide precise guidance for immediate re excision before closing wound While conventional D imagers requires a long scan time min that disrupts surgical workflow our VSI approach is enabled by a patented algorithm that allows much faster imaging by substantially cutting down the amount of data to be collected which offers high resolution D image within minutes In years we plan to introduce VSI as the new standard of care for intra operative lumpectomy margin assessment which may reduce the re excision rate to without unnecessary re excision and mastectomy thereby dramatically reducing healthcare costs and patient inconvenience while improving cosmetic outcomes Our hypothesis for Phase I research is that the VSI can scan typical lumpectomy specimens within minutes yielding D images with over margin assessment sensitivity and specificity The Specific Aims are to verify that image quality requirements can be met by a calibrated VSI prototype to verify that scan time requirements can be met by optimizing VSI parameters and To verify that VSI has higher sensitivity and specificity than SR for assessing lumpectomy margins Reaching the above Aims will firmly establish the feasibility of VSI as a next generation tool for D intra operative margin assessment and would reduce the technical risk of Phase II work which include fully optimization of VSI performance complete integration of the VSI to surgical workflow and larger scale evaluation of VSIandapos s clinical benefit with lumpectomy specimens In the US about surgical labs performing lumpectomy create an installed base estimated at $ B among which large teaching programs and affiliated community hospitals are our lead customers providing an early customer base of $ M PUBLIC HEALTH RELEVANCE Currently up to of patients receiving lumpectomy need reoperations due to positive margins undetected during initial surgery We propose to develop a next generation real time D imaging device that can accurately identify positive margins during the surgery allowing surgeons to immediately remove additional cancerous tissues and thus significantly reducing reoperation rate improving patient outcomes and lowering healthcare cost