System Integration and Preliminary Clinical Evaluation of a Robotic System for MRI-Guided Transperineal Prostate Biopsy

This paper presents the development, preclinical evaluation, and preliminary clinical study of a robotic system for targeted transperineal prostate biopsy under direct interventional magnetic resonance imaging (MRI) guidance. The clinically integrated robotic system is developed based on a modular design approach, comprised of surgical navigation application, robot control software, MRI robot controller hardware, and robotic needle placement manipulator. The system provides enabling technologies for MRI-guided procedures. It can be easily transported and setup for supporting the clinical workflow of interventional procedures, and the system is readily extensible and reconfigurable to other clinical applications. Preclinical evaluation of the system is performed with phantom studies in a 3 Tesla MRI scanner, rehearsing the proposed clinical workflow, and demonstrating an in-plane targeting error of 1.5[Formula: see text]mm. The robotic system has been approved by the institutional review board (IRB) for clinical trials. A preliminary clinical study is conducted with the patient consent, demonstrating the targeting errors at two biopsy target sites to be 4.0[Formula: see text]mm and 3.7[Formula: see text]mm, which is sufficient to target a clinically significant tumor foci. First-in-human trials to evaluate the system’s effectiveness and accuracy for MR image-guided prostate biopsy are underway.

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An Integrated Robotic System for MRI-Guided Neuroablation: Preclinical Evaluation

IEEE Transactions on Biomedical Engineering ◽

10.1109/tbme.2020.2974583 ◽

2020 ◽

Vol 67 (10) ◽

pp. 2990-2999

Author(s):

Niravkumar A. Patel ◽

Christopher J. Nycz ◽

Paulo A. Carvalho ◽

Katie Y. Gandomi ◽

Radian Gondokaryono ◽

...

Keyword(s):

Robotic System ◽

Preclinical Evaluation ◽

Mri Guided

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Inverse Kinematic and Control Architecture of a Slave Manipulator for MR-Guided Brain Biopsy

Volume 2: Biomedical and Biotechnology Engineering ◽

10.1115/imece2008-68302 ◽

2008 ◽

Author(s):

C. Raoufi ◽

A. A. Goldenberg ◽

W. Kucharczyk ◽

H. Hadian

Keyword(s):

Modular Design ◽

Brain Biopsy ◽

Inverse Kinematic ◽

Robotic System ◽

Control Architecture ◽

Neurosurgical Procedures ◽

Biopsy Needle ◽

Mri Guided ◽

Position And Orientation ◽

And Control

In this paper, the inverse kinematic and control paradigm of a novel tele-robotic system for MRI-guided interventions for closed-bore MRI-guided brain biopsy is presented. Other candidate neurosurgical procedures enabled by this system would include thermal ablation, radiofrequency ablation, deep brain stimulators, and targeted drug delivery. The control architecture is also reported. The design paradigm is fundamentally based on a modular design configuration of the slave manipulator that is performing tasks inside MR scanner. The tele-robotic system is a master-slave system. The master manipulator consists of three units including: (i) the navigation module; (ii) the biopsy module; and (iii) the surgical arm. Navigation and biopsy modules were designed to undertake the alignment and advancement of the surgical needle respectively. The biopsy needle is held and advanced by the biopsy module. The biopsy module is attached to the navigation module. All three units are held by a surgical arm. The main challenge in the control of the biopsy needle using the proposed navigation module is to adjust a surgical tool from its initial position and orientation to a final position and orientation. In a typical brain biopsy operation, the desired task is to align the biopsy needle with a target knowing the positions of both the target in the patient’s skull and the entry point on the surface of the skull. In this paper, the mechanical design, control paradigms, and inverse kinematics model of the robot are reported.

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Robotic Transperineal Prostate Biopsy: Pilot Clinical Study

Urology ◽

10.1016/j.urology.2011.07.1389 ◽

2011 ◽

Vol 78 (5) ◽

pp. 1203-1208 ◽

Cited By ~ 24

Author(s):

H. Ho ◽

J.S.P. Yuen ◽

P. Mohan ◽

E.W. Lim ◽

C.W.S. Cheng

Keyword(s):

Clinical Study ◽

Prostate Biopsy ◽

Transperineal Prostate Biopsy ◽

Pilot Clinical Study

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MRI-Guided Transperineal Prostate Biopsy Using Commercially Available Prostate Biopsy Planning Systems

Brachytherapy ◽

10.1016/j.brachy.2017.04.115 ◽

2017 ◽

Vol 16 (3) ◽

pp. S67

Author(s):

R. Alex Hsi ◽

Keith Schulze ◽

Scott Bildsten ◽

Carleen T. Bensen ◽

Aaron Sabolch ◽

...

Keyword(s):

Prostate Biopsy ◽

Planning Systems ◽

Transperineal Prostate Biopsy ◽

Mri Guided

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Enhanced MRI-guided radiotherapy with gadolinium-based nanoparticles: preclinical evaluation with an MRI-linac

Cancer Nanotechnology ◽

10.1186/s12645-020-00065-5 ◽

2020 ◽

Vol 11 (1) ◽

Author(s):

H. L. Byrne ◽

G. Le Duc ◽

F. Lux ◽

O. Tillement ◽

N. M. Holmes ◽

...

Keyword(s):

Mr Imaging ◽

Radiation Treatment ◽

Cine Mri ◽

Clinical Workflow ◽

Nanoparticle Uptake ◽

Image Guided Radiotherapy ◽

Preclinical Evaluation ◽

Cine Mr ◽

Mri Guided ◽

Radiotherapy Treatment

Abstract Background The AGuIX® (NH TherAguix) nanoparticle has been developed to enhance radiotherapy treatment and provide strong MR contrast. These two properties have previously been investigated separately and progressed to clinical trial following a clinical workflow of separate MR imaging followed some time later by radiotherapy treatment. The recent development of MRI-linacs (combined Magnetic Resonance Imaging–linear accelerator systems enabling MRI-guided radiotherapy) opens up a new workflow where MR confirmation of nanoparticle uptake can be carried out at the time of treatment. A preclinical study was carried out to assess the suitability of a gadolinium-containing nanoparticle AGuIX® (NH TherAguix) for nano-enhanced image-guided radiotherapy on an MRI-linac. Methods Treatments were carried out on F344 Fischer rats bearing a 9L glioma brain tumour. Animals received either: (A) no treatment; (B) injection of nanoparticles followed by MRI; (C) radiotherapy with MRI; or (D) injection of nanoparticles followed by radiotherapy with MRI. Pre-clinical irradiations were carried out on the 1.0 T, 6 MV in-line Australian MRI-linac. Imaging used a custom head coil specially designed to minimise interference from the radiotherapy beam. Anaesthetised rats were not restrained during treatment but were monitored with a cine-MRI sequence. Inductively Coupled Plasma Mass Spectrometry (ICP-MS) analysis was used to quantify residual gadolinium in the brain in normal and tumour tissue. Results A preclinical evaluation of nano-enhanced radiation treatment has been carried out on a 1.0 T MRI-linac, establishing a workflow on these novel systems. Extension of life when combining radiotherapy with nanoparticles was not statistically different from that for rats receiving radiotherapy only. However, there was no detrimental effect for animals receiving nanoparticles and radiation treatment in the magnetic field compared with control branches. Cine-MR imaging was sufficient to carry out monitoring of anaesthetised animals during treatment. AGuIX nanoparticles demonstrated good positive contrast on the MRI-linac system allowing confirmation of tumour extent and nanoparticle uptake at the time of treatment. Conclusions Novel nano-enhanced radiotherapy with gadolinium-containing nanoparticles is ideally suited for implementation on an MRI-linac, allowing a workflow with time-of-treatment imaging. Live irradiations using this treatment workflow, carried out for the first time at the Australian MRI-linac, confirm the safety and feasibility of performing MRI-guided radiotherapy with AGuIX® nanoparticles. Follow-up studies are needed to demonstrate on an MRI-linac the radiation enhancement effects previously shown with conventional radiotherapy.

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MRI-Guided, Transperineal Prostate Biopsy Using Fixed Coordinate Needle Guide: Initial Feasibility Study

2019 Design of Medical Devices Conference ◽

10.1115/dmd2019-3281 ◽

2019 ◽

Author(s):

Pankaj Kulkarni ◽

Sumit Laha ◽

Sakura Sikander ◽

Pradipta Biswas ◽

Heather Cornnell ◽

...

Keyword(s):

Image Registration ◽

Prostate Biopsy ◽

Clinical Applications ◽

Proof Of Concept ◽

Procedure Time ◽

3T Mri ◽

Transperineal Prostate Biopsy ◽

Guide System ◽

Mri Guided ◽

Initial Results

Most of the existing MRI guided robotic needle guide systems have been limited to research purposes and have not progressed towards clinical applications due to complex and bulky structures. The ‘device-to-image’ registration step further complicates the operation and significantly increases the overall procedure time. To address limitations, we developed an MRI guided transperineal prostate biopsy guide system that uses the concept of a ‘fixed coordinate device’ to simplify the overall biopsy procedure and eliminate the registration step, making the procedure more clinically friendly. We performed proof-of-concept targeting experiments using an agar phantom under 3T MRI. The targeting results were analyzed, and initial results prove that the simplified intervention concept would well be feasible. We plan to extend the study further to identify error components.

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Radiologic and Pathologic Correlation Using a Commercially Available MRI-Guided Transperineal Prostate Biopsy Planning System

International Journal of Radiation Oncology*Biology*Physics ◽

10.1016/j.ijrobp.2018.07.321 ◽

2018 ◽

Vol 102 (3) ◽

pp. e119

Author(s):

R.A. Hsi ◽

K. Schulze ◽

S. Bildsten ◽

C. Bensen ◽

A. Sabolch ◽

...

Keyword(s):

Prostate Biopsy ◽

Planning System ◽

Pathologic Correlation ◽

Transperineal Prostate Biopsy ◽

Mri Guided

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An Innovative Parallel Robotic System for Transperineal Prostate Biopsy

New Trends in Mechanism and Machine Science - Mechanisms and Machine Science ◽

10.1007/978-3-319-44156-6_43 ◽

2016 ◽

pp. 421-429 ◽

Cited By ~ 2

Author(s):

Bogdan Gherman ◽

Nicolae Plitea ◽

Doina Pisla

Keyword(s):

Prostate Biopsy ◽

Robotic System ◽

Transperineal Prostate Biopsy

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Development of a Device-to-Image Registration Free Needle Guide for Magnetic Resonance Imaging-Guided Targeted Prostate Biopsy

Journal of Medical Devices ◽

10.1115/1.4047874 ◽

2020 ◽

Vol 14 (4) ◽

Author(s):

Pankaj Kulkarni ◽

Sakura Sikander ◽

Pradipta Biswas ◽

Sumit Laha ◽

Heather Cornnell ◽

...

Keyword(s):

Magnetic Resonance Imaging ◽

Magnetic Resonance ◽

Image Registration ◽

Prostate Biopsy ◽

Signal To Noise Ratio ◽

Clinical Environment ◽

Resonance Imaging ◽

Transperineal Prostate Biopsy ◽

Mri Guided ◽

Magnetic Resonance Imaging Mri

Abstract Significant research has been done in the past decade for the development of magnetic resonance imaging (MRI) guided needle guide (NG) systems for prostate intervention. Most of these systems have been restricted to application in the lab environment with lack of progress toward clinical application. Bulky and complex designs can be attributed to this practice. These systems also demand complex technical setup and usage procedures, which require extra technical personnel during the intervention in addition to specialized training for physicians. Moreover, “device-to-image” registration, essential for accurate and precise targeting, further complicates the overall process while increasing total time for intervention. In order to address these limitations, a simplified, MRI-guided, transperineal prostate biopsy NG system was designed and developed for rapid adoption into the clinical environment. The system consists of a NG device and a software toolkit. It does not require any special intraprocedural technical expertise or dedicated training. Also, to simplify and shorten total procedure time, the device uses the unique concept of “fixed coordinate device” eliminating the need for any device-to-image registration making it clinically friendly. To verify the NG design along with the registration free feature, image quality tests and agar phantom-based targeting experiments were performed under the guidance of 3T MRI scanner. The imaging tests resulted in a distortion of less than 1% in presence of the device and an average change of 1.3% in signal-to-noise ratio. For targeting experiments, maximum in-plane error distance of 3.8 mm with a mean of 2.2 mm and standard deviation of 0.8 mm was observed. The results show that an MRI-compatible simplified intervention device without the need of device-to-image registration is technically feasible.

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