MRI-guided percutaneous needle biopsy with 1.2T open MRI: Study protocol for a prospective feasibility study (SCIRO-1701)

There has been growing interest in magnetic resonance imaging (MRI)-guided interventional procedures such as percutaneous needle biopsy. Although open MRI is preferable for MRI-guided procedures in terms of patient accessibility, its inferior imaging capability due to lower field strength is a substantial limitation. In this situation, the high-field (1.2T) open MRI has recently become available. This novel MRI system is expected to provide excellent image quality as well as good patient accessibility, potentially contributing to safe and accurate device manipulation. This trial is designed to investigate the feasibility of MRI-guided percutaneous needle biopsy with this system. Patients with lesions needing percutaneous needle biopsy for pathological diagnosis are included. The enrollment of ten patients is intended. The primary endpoint of this study is the feasibility of biopsy needle insertion under real-time MR-fluoroscopy guidance based on the presence of the notch of the biopsy needle within the target lesion. The secondary endpoints are adverse events, device failures, and success of specimen acquisition. Once the feasibility of MRI-guided biopsy with 1.2T open MRI is validated by this study, it may potentially encourage widespread use of MRI-guidance for biopsy procedures. Furthermore, it may lead to development of the other MRI-guided interventional procedures using this MRI system.