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

Abstract

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 6-degree-of-freedom, pneumatically actuated robot for transperineal prostate percutaneous access, built exclusively of electrically nonconductive and nonmagnetic materials. Its extensive pre-clinical 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 FDA has approved the MrBot for the biopsy trial, which was successfully performed in 5 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.

The Current State of MR Imaging–targeted Biopsy Techniques for Detection of Prostate Cancer

“…Only a single targeting device for robotic-assisted MR imaging is approved by the U.S. Food and Drug Administration (56). These devices are mainly used in research settings, and therefore are only briefly discussed here.…”

Robot-Assisted Fluoroscopy Versus Ultrasound-Guided Renal Access for Nephrolithotomy: A Phantom Model Benchtop Study

“…21 In addition, there is a development of other robot devices that are integrated with the magnetic resonance imaging (MRI) system for transperineal prostate percutaneous access, which is called MrBot robot. 22 The clinical application of MrBot has already been approved by the Food and Drug Administration because of its accuracy and safety for patients. Although these CT-and MRI-integrated navigation systems promote safe and accurate procedures, the renal access during PCNL is mainly performed under either fluoroscopic or US guidance rather than under CT or MRI guidance.…”

CT and MRI compatibility of flexible 3D‐printed materials for soft actuators and robots used in image‐guided interventions

“…As these techniques mature and allow an ever more detailed morphological and functional assessment of tissues and organs, researchers and clinicians are increasingly eager to employ CT and MR imaging not only for diagnostics but also during treatment in image‐guided interventions . Examples for these procedures under intraoperative CT or MRI visualization include image‐guided prostate therapy and biopsies, dynamic CT angiography, vascular interventions, neurosurgery, and rehabilitation monitoring …”

“…Furthermore, these imaging techniques can show organ functions, for example, brain activity using functional MRI (fMRI), 1-3 organ perfusion using arterial spin labeling MRI, 4 or metabolic activity using positron emission tomography (PET)-CT. 5,6 As these techniques mature and allow an ever more detailed morphological and functional assessment of tissues and organs, researchers and clinicians are increasingly eager to employ CT and MR imaging not only for diagnostics but also during treatment in image-guided interventions. 7 Examples for these procedures under intraoperative CT or MRI visualization include image-guided prostate therapy 8 and biopsies, 9,10 dynamic CT angiography, 11 vascular interventions, 12 neurosurgery, 13 and rehabilitation monitoring. 14,15 Performing image-guided interventions is a challenging task.…”