Surgical navigation system for in-bore MRI-guided breast interventions

项目描述（由申请人提供）：该项目的长期目标是开发一种外科导航系统，该系统可以在任何类型的扫描仪上实现内腔、磁共振成像引导干预。这个新系统将有助于使用核磁共振成像来指导诊断和治疗干预。与其他成像方式相比，MRI具有独特的优势-它具有异常高的软组织对比度，它使用非电离辐射，可以在体内任何位置和方向进行成像，不会因空气，骨骼或其他身体结构而产生阴影或阻塞。将这些独特的成像特征与实时MRI引导下方便的指导干预手段相结合，以微创干预替代各种外科手术，对癌症患者的管理具有重要作用。该项目的具体目标是调整目前的EndoScout跟踪系统，以指导封闭孔MRI扫描仪内的乳房活检；评估系统的准确性，测试其人机界面；开展多中心临床研究，评估新系统的安全性和有效性；并获得FDA的上市许可。为了实现这些目标，罗宾医疗将与三家临床机构合作。Robin Medical将调整EndoScout跟踪系统用于闭孔扫描仪，将进行技术研究以验证系统的准确性，将在临床试验点制造和安装手术导航系统，将监督多中心临床研究，并将努力使产品获得FDA的批准。诺顿医院（Louisville， KY）的iMRI中心，EndoScout系统在其开发过程中通过了严格的测试，将为新系统的技术测试提供环境。布里格姆妇女医院（波士顿，马萨诸塞州）将在第二年与诺顿医院合作，两家医院将在他们的开放式磁共振扫描仪上进行初步的人体研究，在那里可以立即选择手动活检。在证明该系统的可靠性和安全性之后，将在这两个地点和华盛顿特区的乔治华盛顿大学医学中心进行一项多中心临床研究。由于缺乏方便的方法来引导mri扫描仪内的活检，mri检测到的病变的活检是用不太可靠的立体定向设备或开放手术活检。开发一种简单、低成本的系统，以方便在任何闭孔扫描仪上进行核磁共振引导的乳房活检，将减少许多患者手术活检的使用，并可能为医疗保健系统节省大量成本。

DESCRIPTION (provided by applicant): The project long-term objective is to develop a surgical navigational system that will enable in-bore, MR imaging guided interventions on any type of scanner. This new system will facilitate the use of MRI to guide diagnostic and therapeutic interventions. MRI has unique advantages compared with other imaging modalities - it has exceptional high soft-tissue contrast, it uses non-ionizing radiation, imaging can be done in any position and orientation inside the body, there is no shadowing or blocking due to air, bones, or other body structure. Coupling these unique imaging characteristics with a convenient mean to guide intervention under real-time MRI guidance can have significant effect on the management of cancer patients by replacing various surgical procedures with minimally invasive interventions. The specific aims of the project are to adapt the current EndoScout tracking system to guide breast biopsy inside closed-bore MRI scanners; to evaluate the accuracy of the system and to test its human-machine interface; to conduct a multi-center clinical study to evaluate the safety and efficacy of the new system; and to achieve FDA clearance for marketing. To accomplish these aims, Robin Medical will collaborate with three clinical institutions. Robin Medical will adapt the EndoScout tracking system for use on closed bore scanners, will conduct technical studies to verify the accuracy of the system, will manufacture and install the surgical navigation systems in the clinical testing sites, will supervise the multi-center clinical study, and will work to achieve FDA clearance of the product. The iMRI Center at the Norton Hospital (Louisville, KY), where the EndoScout system passed rigorous testing during its development, will provide the setting for the technical testing of the new system. The Brigham and Women's Hospital (Boston, MA) will join Norton Hospital during the second year and both sites will conduct the initial human study on their open MR scanners, where an immediate backup option for manual biopsy is available. Following the demonstration of the reliability and the safety of the system, a multicenter clinical study will be conducted at these two sites and at The George Washington University Medical Center in Washington, DC. Due to lack of convenient way to guide biopsy inside the bore of MR scanners, biopsies of MRI-detected lesions are done with less reliable stereotactic apparatus or by open surgical biopsy. The development of a simple, low-cost system to facilitate MR-guided breast biopsy on any closed bore scanner will reduce the use of surgical biopsy in many patients and may lead to a substantial cost saving to the healthcare system.