SURGICAL NAVIGATION SYSTEM FOR IN-BORE MRI-GUIDED BREAST INTERVENTIONS - 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.
