Safety Clearance and Artifact Testing of a Nitinol Breast Biopsy Clip in an Ultra-High Resolution (7 Tesla) Magnetic Resonance Imaging Environment

Abstract

Abstract Background The lack of safety clearance of several metallic breast biopsy clips in 7 Tesla (T) poses a significant hurdle to using advanced magnetic resonance imaging (MRI) techniques in clinical management or cancer research. Aims This article assesses the Ultracor Twirl clip for safety and imaging artifacts in a 7T MRI scanner. Setting and Design This study can be categorized as a phantom study. Materials and Methods Tests for magnetic susceptibility (translational attraction and torque), MRI-related heating, and artifacts were conducted based on the American Society for Testing and Materials standards. The magnetic susceptibility tests evaluated the scanner's magnetic force that can cause clip movement and rotation. The heating test was conducted with customized MRI parameters of short TR and maximum echo-train length, designed to induce temperature change. The artifact test, using T1-weighted spin and gradient echo imaging sequences, evaluated potential image misrepresentations (localized signal loss) caused by the clip's metallic properties. Statistical Tests None. Results and Conclusion The magnetic susceptibility tests indicated no noticeable translational or rotational force exerted by the MRI scanner. The heating test indicated no significant temperature change (<0.3°C) in the testing gel when the clip was absent/present, both within the safety threshold (<1°C). The artifact test's clip images all contained an artifact (largest radius = 10.7 mm). These cumulative results indicate that this clip is safe in 7T scanners. Scanning at least 10.7 mm away from the clip avoids potential signal loss in the region of interest.