Changhan Jun

MR Safe Robot, FDA Clearance, Safety and Feasibility of Prostate Biopsy Clinical Trial

Compatibility of mechatronic devices with the MR environment has been a very challenging engineering task. After over a decade of developments, we report the successful translation to clinical trials of our MR safe robot technology. MrBot is a six degree of freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive preclinical tests have been previously reported. Here, we present the latest technology developments, an overview of the regulatory protocols, and technically related results of the clinical trial. The Food and Drug Administration (FDA) has approved the MrBot for the biopsy trial, which was successfully performed in five patients. With no trajectory corrections and no unsuccessful attempts to target a site, the robot achieved an MRI-based needle targeting accuracy of 2.55 mm. To the best of our knowledge, this is the first robot approved by the FDA for the MR environment. The results confirm that it is possible to perform safe and accurate robotic manipulation in the MRI scanner, and the development of MR safe robots is no longer a daunting technical challenge.

Multi-Imager Compatible, MR Safe, Remote Center of Motion Needle-Guide Robot

We report the development of a new robotic system for direct image-guided interventions (DIGI; images acquired at the time of the intervention). The manipulator uses our previously reported pneumatic step motors and is entirely made of electrically nonconductive, nonmetallic, and nonmagnetic materials. It orients a needle-guide with two degrees of freedom (DoF) about a fulcrum point located below the guide using an innovative remote center of motion parallelogram type mechanism. The depth of manual needle insertion is preset with a third DoF, located remotely of the manipulator. Special consideration was given to the kinematic accuracy and the structural stiffness. The manipulator includes registration markers for image-to-robot registration. Based on the images, it may guide needles, drills, or other slender instruments to a target (OD < 10 mm). Comprehensive preclinical tests were performed. The manipulator is MR safe (ASTM F2503-13). Electromagnetic compatibility (EMC) testing (IEC 60601-1-2) of the system shows that it does not conduct or radiate EM emissions. The change in the signal to noise ratio of the MRI due to the presence and motion of the robot in the scanner is below 1%. The structural stiffness at the needle-guide is 33 N/mm. The angular accuracy and precision of the manipulator itself are 0.177° and 0.077°. MRI-guided targeting accuracy and precision in vitro were 1.71 mm and 0.51 mm, at an average target depth of ∼38 mm, with no adjustments. The system may be suitable for DIGI where

Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device

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MR Safe Robot Assisted Needle Access of the Brain: Preclinical Study

[mm] accuracy lateral to the needle (2D) or

Robotically Assisted Long Bone Biopsy Under MRI Imaging: Workflow and Preclinical Study

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Geometric systematic prostate biopsy.

[mm] in 3D is acceptable. The system is also multi-imager compatible and could be used with other imaging modalities.

Using optical tracking for kinematic testing of medical robots

OBJECTIVE To evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI)-guided prostate biopsy using a novel robotic device. METHODS MrBot is an MRI-safe robotic device constructed entirely with nonconductive, nonmetallic, and nonmagnetic materials and developed by our group. A safety and feasibility clinical trial was designed to assess the safety and feasibility of a direct MRI-guided biopsy with MrBot and to determine its targeting accuracy. Men with elevated prostate-specific antigen levels, prior negative prostate biopsies, and cancer-suspicious regions (CSRs) on MRI were enrolled in the study. Biopsies targeting CSRs, in addition to sextant locations, were performed. RESULTS Five men underwent biopsy with MrBot. Two men required Foley catheter insertion after the procedure, with no other complications or adverse events. Even though this was not a study designed to detect prostate cancer, biopsies confirmed the presence of a clinically significant cancer in 2 patients. On a total of 30 biopsy sites, the robot achieved an MRI-based targeting accuracy of 2.55 mm and a precision of 1.59 mm normal to the needle, with no trajectory corrections and no unsuccessful attempts to target a site. CONCLUSION Robot-assisted MRI-guided prostate biopsy appears safe and feasible. This study confirms that a clinically significant prostate cancer (≥5-mm radius, 0.5 cm3) depicted in MRI may be accurately targeted. Direct confirmation of needle placement in the CSR may present an advantage over fusion-based technology and gives more confidence in a negative biopsy result. Additional study is warranted to evaluate the efficacy of this approach.

MP52-14 TRUS ROBOT-ASSISTED PROSTATE BIOPSY: A FEASIBILITY STUDY

We report the results of preclinical experiments for direct MRI-guided needle interventions in the brain. An MR Safe robot was incorporated into an intraoperative MRI system. Deep regions of the brain simulated in a cranial mockup were targeted with a needle under robotic assistance. The 3D accuracy of in-scanner targeting at an average depth of 95mm was 1.55mm, with no manual corrections.

MP52-15 COMPARATIVE ASSESSMENT OF CORE BIOPSY NEEDLES

RATIONALE AND OBJECTIVES Our research team has developed a magnetic resonance imaging (MRI)-compatible robot for long bone biopsy. The robot is intended to enable a new workflow for bone biopsy in pediatrics under MRI imaging. Our long-term objectives are to minimize trauma and eliminate radiation exposure when diagnosing children with bone cancers and bone infections. This article presents our robotic systems, phantom accuracy studies, and workflow analysis. MATERIALS AND METHODS This section describes several aspects of our work including the envisioned clinical workflow, the MRI-compatible robot, and the experimental setup. The workflow consists of five steps and is intended to enable the entire procedure to be completed in the MRI suite. The MRI-compatible robot is MR Safe, has 3 degrees of freedom, and a remote center of motion mechanism for orienting a needle guide. The accuracy study was done in a Siemens Aera 1.5T scanner with a long bone phantom. Four targeting holes were drilled in the phantom. RESULTS Each target was approached twice at slightly oblique angles using the robot needle guide for a total of eight attempts. A workflow analysis showed the average time for each targeting attempt was 32 minutes, including robot setup time. The average 3D targeting error was 1.39 mm with a standard deviation of 0.40 mm. All of the targets were successfully reached. CONCLUSION The results showed the ability of the robotic system in assisting the radiologist to precisely target a bone phantom in the MRI environment. The robot system has several potential advantages for clinical application, including the ability to work at the MRI isocenter and serve as a steady and precise guide.

A surface tension magnetophoretic device for rare cell isolation and characterization

Abstract Objective: The common sextant prostate biopsy schema lacks a three-dimensional (3D) geometric definition. The study objective was to determine the influence of the geometric distribution of the cores on the detection probability of prostate cancer (PCa). Methods: The detection probability of significant (>0.5 cm3) and insignificant (<0.2 cm3) tumors was quantified based on a novel 3D capsule model of the biopsy sample. The geometric distribution of the cores was optimized to maximize the probability of detecting significant cancer for various prostate sizes (20–100cm3), number of biopsy cores (6–40 cores) and biopsy core lengths (14–40 mm) for transrectal and transperineal biopsies. Results: The detection of significant cancer can be improved by geometric optimization. With the current sextant biopsy, up to 20% of tumors may be missed at biopsy in a 20 cm3 prostate due to the schema. Higher number and longer biopsy cores are required to sample with an equal detection probability in larger prostates. Higher number of cores increases both significant and insignificant tumor detection probability, but predominantly increases the detection of insignificant tumors. Conclusion: The study demonstrates mathematically that the geometric biopsy schema plays an important clinical role, and that increasing the number of biopsy cores is not necessarily helpful.