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

描述（由申请人提供）：该项目的长期目标是开发一种手术导航系统，该系统将能够在任何类型的扫描仪上进行孔内MR成像引导干预。这一新系统将促进MRI的使用，以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-它具有非常高的软组织对比度，它使用非电离辐射，可以在体内的任何位置和方向进行成像，没有由于空气，骨骼或其他身体结构造成的阴影或阻挡。将这些独特的成像特征与在实时MRI引导下引导干预的方便手段相结合，可以通过用微创干预取代各种外科手术来对癌症患者的管理产生显著影响。该项目的具体目标是调整当前的EndoScout跟踪系统，以引导闭孔MRI扫描仪内的乳腺活检;评估系统的准确性并测试其人机界面;进行多中心临床研究，以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，Robin Medical将与三家临床机构合作。Robin Medical将调整EndoScout跟踪系统以用于闭孔扫描仪，将进行技术研究以验证系统的准确性，将在临床试验机构制造和安装手术导航系统，将监督多中心临床研究，并将努力实现产品的FDA批准。诺顿医院（肯塔基州路易斯维尔）的iMRI中心将为新系统的技术测试提供设置，EndoScout系统在开发期间通过了严格的测试。布里格姆妇女医院（马萨诸塞州波士顿）将在第二年加入诺顿医院，两家研究中心将在其开放式MR扫描仪上进行初步人体研究，其中可提供手动活检的即时备份选项。在证明系统的可靠性和安全性后，将在这两家临床试验机构和位于华盛顿的乔治华盛顿大学医学中心进行多中心临床研究。由于缺乏在MR扫描仪的孔内引导活检的方便方法，MRI检测到的病变的活检使用不太可靠的立体定向设备或通过开放手术活检来完成。开发一种简单、低成本的系统，以便于在任何闭孔扫描仪上进行MR引导乳腺活检，这将减少许多患者使用手术活检，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.