SBIR Phase I: Combined endorectal prostatic Magnetic Resonance Imaging and Biopsy Device to Enable Single Combined Procedures

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve the care of men with suspected prostate cancer, by providing the benefits of tumor localization within the prostate by state of the art endorectal multiparametric MRI combined with the benefits of precision biopsy using MRI-targeted needle sampling as a single patient-convenient procedure. The current standard approach to prostate cancer, transrectal ultrasound guided systematic biopsy, requires 12 needle samples from standard locations in the prostate with the hope of hitting any cancer that might be present. This option is essentially playing a game of battleships with the prostate, and is, unsurprisingly, inaccurate with high rates of underdiagnosis and overdiagnosis. Many patients require repeated biopsy because of these inaccuracies. By way of contrast, it is inconceivable that breast cancer would be diagnosed by placing twelve needles at standard locations in the breast, yet this has been the longstanding 'state-of-the-art' for prostate cancer. With approximately one million prostate biopsies are performed annually in the U.S., the market and clinical need is large and of major socioeconomic importance.The proposed project will preliminarily determine the technical and commercial feasibility of combining an endorectal MRI coil with a transrectal multichannel array of biopsy needle guides into a single device that would provide the ability to perform MRI for diagnosis and targeted needle placement as a single integrated procedure. Such a device could transform the current paradigm for prostate cancer diagnosis, providing greater precision, personalization, and patient convenience. To determine technical feasibility, the project plan is to fabricate and 3D print a proof-of-concept device for initial simulation experiments and selection of the final coil configuration, evaluate imaging performance of the device coil by measuring signal to noise ratio on standard MR images in a human male pelvic phantom and evaluate the fidelity of needle deployment by measurement of linear deviation between actual and intended needle positioning in a phantom in transverse and longitudinal directions. At all stages, continuous design and engineering modifications will be made to ensure satisfactory technical performance.