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

Description

Project Summary Abstract Physical Sciences IncPSIin collaboration with the Department of Radiology at Brigham and Womenandapos s HospitalBWHproposes to develop a double action Smart Template to aid transperineal targeted prostate biopsies and subsequent focal therapy procedures performed under magnetic resonance imagingMRIguidanceDespite the high sensitivity in identifying prostate cancer with MRI imaginginaccurate placement of the biopsy needle into the MRI highlighted area of the organ often fails to confirm cancer presence and leads to repeated costly biopsies and potentially delayed treatmentThe PSI BWH team has developed a passive grid Smart Template technology that enables accurate insertion of the biopsy needle and positioning into a suspicious prostate cancer tissueIts clinical efficacy has already been demonstrated in multiple patientsThis technology however requires further improvementadvanced engineeringand clinical evaluation to support commercializationIn this Fast Track program we propose to further advance the technology by eliminating the passive gridenabling countless entry pointsand automated positioning and angulation of the needleThe angled insertion will enable avoidance of the perineal structures such as scar tissue and other areas that cause deflection of biopsy needlePatient movement during the biopsy procedures will also be monitoredand the biopsy needle trajectory will be corrected using a custom algorithm for the accurate biopsy needle displacement to the target cancer lesionThe double action Smart Template will be first evaluated and optimized in perineal animal modelsand then its efficacy will be tested in vivo in human patients utilizing aT MRI scanner at BWH Project Narrative The central focus of this project is to improve the diagnostic accuracy of MRI guided transperineal prostate biopsy by providing precise biopsy needle displacement using a Smart Template technologyThe proposed device will increase prostate cancer detection rate and help reduce unnecessary repeated biopsies that cause tissue morbidityinfection and substantially increase procedural costs