Physical Sciences Inc. (PSI), in collaboration with the Department of Radiology at Brigham and Women's Hospital (BWH), proposes to develop a double-action Smart Template to aid transperineal targeted prostate biopsies and subsequent focal therapy procedures performed under magnetic resonance imaging (MRI)- guidance. Despite the high sensitivity in identifying prostate cancer with MRI imaging, inaccurate 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 treatment. The 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 tissue. Its clinical efficacy has already been demonstrated in multiple patients. This technology however requires further improvement, advanced engineering, and clinical evaluation to support commercialization. In this Fast-Track program we propose to further advance the technology by eliminating the passive grid, enabling countless entry points, and automated positioning and angulation of the needle. The angled insertion will enable avoidance of the perineal structures such as scar tissue and other areas that cause deflection of biopsy needle. Patient movement during the biopsy procedures will also be monitored, and the biopsy needle trajectory will be corrected using a custom algorithm for the accurate biopsy needle displacement to the target cancer lesion. The double-action Smart Template will be first evaluated and optimized in perineal animal models, and then its efficacy will be tested in vivo in human patients utilizing a 3T MRI scanner at BWH.
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 technology. The proposed device will increase prostate cancer detection rate and help reduce unnecessary repeated biopsies that cause tissue morbidity, infection and substantially increase procedural costs.
