Physical Sciences Inc. (PSI) and the Surgical Navigation and Robotics Laboratory (SNR) at Brigham and Women's Hospital (BWH) propose to develop and test a Smart Template to guide transperineal targeted prostate biopsies and subsequent therapy under magnetic resonance imaging (MRI). The project aims to solve the problem of poor diagnostic yield in prostate biopsies. As many as half of cancers in the prostate are missed in an initial diagnostic biopsy, resulting in repeated biopsy, oversampling, and delayed treatment. The proposed device provides precise control of needle entry location based on diagnostic and intra-operative (MRI), leading to precise targeting of suspicious tissue. SNR has been developing and testing prototypes of the device for several years. In this STTR program, the technology will be transferred to PSI for advanced engineering development and commercialization. Because SNR has tested prototypes of the device, we have identified the issues to be addressed in moving the device forward and quantified the requirements for verifying feasibility. Robots for performing targeted prostate biopsies have been tested by the SNR team and other researchers. In contrast to other devices, when using the Smart Template the needle is inserted by the clinician. Regulatory safety concerns about robots are thus minimized, cost of the device is much reduced, and clinicians will feel more comfortable using it because they retain a greater degree of control and tactile feedback. In the Phase I program, PSI engineers will work with scientists at SNR to make design upgrades necessary to meet the feasibility goals. These design upgrades will be based on SNR's experience of testing a prototype smart template in 43 patients. The upgrades will be tested on an existing prototype of the Smart Template. Phase I will conclude with a demonstration of targeting accuracy on a tissue phantom in an MRI scanner.
Early detection of prostate cancer is a key for survival. Doctors can often identify potentially-cancerous prostate tissue on an MRI even after a negative ultrasound-guided biopsy but getting a biopsy needle to the precise location for confirmation is difficult. The proposed device will assist precise needle placement based on the MRI scans and should result in fewer repeat biopsies and fewer missed cancers.