The objective of this research is to demonstrate the feasibility of, and point the way toward, MRI-guided breast cancer diagnosis and therapy. This effort will address several pressing needs in MRI-based breast cancer interventions by integrating real-time magnetic resonance imaging and precision placement/monitoring of diagnostic/therapeutic probes. Breast MRI, while extremely effective in detecting cancers, has yet to produce an efficient method for either biopsies or localized therapies. By developing a fully MRI-compatible robotic probe placement system that can be monitored by MRI in real-time, the accuracy and precision of many procedures can be considerably improved. In addition, performing the procedure while the patient is inside the scanner can provide a drastic reduction in procedure time, providing increasing patient comfort and decreased cost to patients and healthcare providers.
The aim of this Phase I proposal is to engineer a comprehensive device and procedure coupling non-invasive MR diagnostics with minimally-invasive MR-guided needle biopsy. This is a new venture of Blake Larson and Dr. J. Thomas Vaughan of Bioengineering, Inc., a small business dedicated to MRI-related diagnostics and therapeutics. We will develop robotics for remote control of the device, custom MR receiver coils, and appropriate control software. By using five positional degrees of freedom (DOF), the robotic placement device will have unprecedented flexibility in placing a biopsy needle or other probes. Using the custom MR receiver coil, the proposed minimally-invasive, interventional system will make use of 3D information provided by MRI to allow unprecedented flexibility in accessing the breast tissue in vivo. A successful outcome of this Phase I project will be a full functional prototype system consisting of a robotic placement device, a dedicated MR coil, and software to control the system. Feasibility will be demonstrated by performing multiple accurate, precise, and safe image-guided needle biopsies on breast phantoms in a 4 tesla (T) MRI scanner at the University of Minnesota's Center for Magnetic Resonance Research. Future Phase II plans will include multi-site human studies of image-guided biopsies, marker placement, and therapies such as cryoablation, radiofrequency (RF) ablation, and percutaneous lesion removal systems. This research will produce a viable platform for MRI-guided diagnostics and therapeutics that will allow more accurate and useful diagnosis and therapy of breast tumors that are not visible using x-ray mammography or ultrasound. By using real-time probe positioning, procedure time will be significantly reduced as compared to the current procedures that iterate with procedure planning, probe placement, placement verification, and often necessary readjustments. In addition to increasing patient comfort, this reduced procedure time presents significant cost savings that will make breast MRI more available to young women and those with family histories that currently have difficulty with insurance reimbursements. ? ? ?
