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

用于腔内 MRI 引导乳腺干预的手术导航系统

• 批准号: 7155579
• 负责人: Erez Nevo
• 金额: $ 59.6万
• 依托单位: ROBIN MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-29 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7155579
• 关键词: biopsy; clinical research; mammary gland

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.

描述（由申请人提供）：项目的长期目标是开发一种手术导航系统，该系统将对任何类型的扫描仪进行孔内，MR成像的指导干预措施。该新系统将促进MRI指导诊断和治疗性干预措施。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，可以在体内的任何位置和方向上进行成像，由于空气，骨骼或其他身体结构，没有阴影或阻塞。将这些独特的成像特性与方便的平均值结合起来，以实时MRI指导下指导干预，可以通过用微创干预措施替换各种手术程序来对癌症患者的治疗产生重大影响。该项目的具体目的是调整当前的内科武器跟踪系统，以指导闭孔MRI扫描仪内部的乳房活检；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功效；并实现FDA的营销许可。为了实现这些目标，罗宾医学将与三个临床机构合作。 Robin Medical将适应用于封闭孔扫描仪的Endoscout跟踪系统，将进行技术研究以验证系统的准确性，将在临床测试站点中制造和安装外科导航系统，将监督多中心临床研究，并将努力实现产品的FDA清除。诺顿医院（肯塔基州路易斯维尔）的IMRI中心在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设置。杨百翰和妇女医院（马萨诸塞州波士顿）将在第二年加入诺顿医院，两个地点将对开放的MR Scanners进行最初的人类研究，其中可以立即提供手动活检的备份选项。在证明了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多中心临床研究。由于缺乏方便的方法来指导MR扫描仪内部的活检，因此，MRI检测病变的活检是使用不可靠的立体定向设备或开放手术活检完成的。开发一个简单的低成本系统，以促进任何封闭的孔扫描仪上的MR引导乳房活检，将减少许多患者的手术活检，并可能导致医疗保健系统节省大量成本。