PHYSICAL SCIENCES INC. — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant Physical Sciences Inc PSI in collaboration with Memorial Sloan Kettering Cancer Center MSKCC and Caliber Imaging andamp Diagnostics Inc Caliber ID proposes to develop a hand held reflectance confocal microscopy optical coherence tomography RCM OCT imaging probe and clinically evaluate its potential use for guiding laser ablation therapy of BCC basal cell carcinoma BCC While RCM provides en face images with nuclear level resolution in superficial skin to depths of about m OCT provides cross sectional images with structural level resolution in the deeper skin layers to depths of at least mm The complementary capabilities of these two optical technologies may be exploited to aid BCC laser ablation therapy Laser ablation is particularly effective for minimally invasive removal of superficial and early nodular BCCs Superficial and early nodular BCCs constitute about per year of Mohs surgical cases Skin can be removed in m thin layers in a highly controlled manner However tissue is vaporized during ablation such that there is none available for immediate pathological evaluation for the presence or clearance of tumor The lack of pathological feedback results in variable efficacy and limited cure rate A high resolution nuclear level optical imaging approach with RCM and depth spreading with OCT may address this limitation by detecting the presence or clearance of residual BCCs directly on the patient and provide immediate pathology like feedback Phase I study has demonstrated the suitability of combining these technologies within the same instrument as well as the clinical value of the complimentary data In Phase II we propose to develop a novel hand held probe that will combine RCM and PSOCT within the same optical layout and perform its clinical evaluation for guiding laser ablation therapy of BCCs PUBLIC HEALTH RELEVANCE Reflectance confocal microscopy and optical coherence tomography are powerful optical imaging technologies for imaging biological tissue at the micron scale level The combination of these technologies into an integrated hand held probe will enable noninvasive and real time screening of skin cancers to determine cancer lateral margins and spreading depth These data will serve for guiding the laser ablation therapy which could replace Mohs surgery Besides the elimination of emotional costs and patient discomfort this technology may significantly reduce US healthcare costs by significantly improving therapy results