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

这个小企业创新研究（SBIR）一期项目的更广泛的影响/商业潜力是改善疑似前列腺癌患者的护理，通过最先进的直肠内多参数MRI提供前列腺内肿瘤定位的好处，结合使用MRI靶向针样作为单一患者方便的程序的精确活检的好处。目前前列腺癌的标准方法是经直肠超声引导的系统活检，需要从前列腺的标准位置取12个针样，希望能发现任何可能存在的癌症。这个选择本质上是在和前列腺玩一场战舰的游戏，毫无疑问，由于诊断不足和过度诊断的高比率，它是不准确的。由于这些不准确，许多患者需要重复活检。相比之下，通过在乳房的标准位置放置12根针来诊断乳腺癌是不可思议的，然而这一直是前列腺癌长期以来的“最先进”技术。在美国，每年约有100万例前列腺活检，市场和临床需求很大，具有重要的社会经济意义。拟议的项目将初步确定将直肠内MRI线圈与经直肠多通道活检针引导阵列结合为一个设备的技术和商业可行性，该设备将提供MRI诊断和靶向针头放置的能力，作为一个单一的集成程序。这种设备可以改变目前前列腺癌诊断的模式，提供更高的精度、个性化和患者便利性。为了确定技术可行性，项目计划是制造和3D打印一个概念验证设备，用于初始模拟实验和最终线圈配置的选择。通过测量男性骨盆幻像的标准MR图像的信噪比来评估设备线圈的成像性能，并通过测量幻像中实际和预期针头定位在横向和纵向上的线性偏差来评估针头部署的保真度。在所有阶段，将进行持续的设计和工程修改，以确保令人满意的技术性能。

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.