This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Grant Number: 1R01CA111288-01A1 PI Name: Clare M. Tempany, MD PI Email: PI Title: Director of Clinical MRI, BWH Project Title Enabling Technologies for MRI-Guided Prostate Interventions Project Start 01-JUL-2006 Project End 31-MAY-2011 Abstract: MRI is an ideal imaging tool for guiding and monitoring prostate cancer biopsy and local therapy. The high sensitivity and specificity to focal prostate lesions and abnormalities, combined with real-time monitoring of the delivery process and subsequent physiological changes hold great potentials. Unfortunately, closed high-field MRI scanners, the most superior imaging systems, have been unavailable for interventions. The strong magnetic field and confined physical space present formidable challenges, and 'conventional' difficulties such as needle deflection, tissue deformation, and target motion add to the problem. Our teams have established the clinical and technical feasibility for MRI-guided prostate biopsy and therapy. We are proposing to translate this technology outside the confines of our specialized research hospitals. In particular, we will develop a technology platform for precise trans-perineal needle placement into the prostate for both diagnostic and therapeutic purposes; inside conventional (high-field closed) MRI scanners, under real-time image guidance and monitoring. This system will be uniformly applicable to'a wide range of MRI scanners, supporting long bore, short bore, and open magnets of high and low fields alike. The initial applications will be prostate biopsy and low-dose-rate Brachytherapy. This system will be robust, simple, and operable by a multi-disciplinary team of physicians. Toward this goal, we propose a BRP between the Brigham and Women's Hospital, Johns Hopkins University, and CMS Image Guidance Division (formerly Burdette Medical). Our teams have complimentary strengths in MR guided interventions, robotics, and prostate cancer treatment with intraoperative dosimetry. A research triangle has been in de-facto existence for several years and produced shared technology, publications, and inventions; supported by government grants. The Brigham group established the clinical feasibility of MR guided transperineal prostate biopsy and brachytherapy, funded by RO1-5R01AG019513-03 (PI Tempany). The Hopkins team created an in-MRI prostate robot currently in human trials for biopsy and seed placement, co-funded by R01-EB002963-01 (PI: Fichtinger). The Burdette group developed a commercial prostate cancer brachytherapy suite with over 60 installations worldwide, co-funded by NIH grants 5R44CA088139-04 and 1R43CA099374-01 (PI: Burdette). Strong results, multidisciplinary expertise, and existing partnerships support our proposal. STATED MILESTONES BY GRANT YEARYEAR 1Design, Development Plan, Systems Requirements Specs for InterplantMR complete. YEAR 2Interface design between robot, MRI scanner, and InterplantMR complete. Software coding standards and systems design descriptions complete. Basic robotic assistant device tested. Basic framework and components tested. YEAR 3Integrated system with basic biopsy capabilities tested. Biopsy clinical trial starts. Integrated system with brachytherapy capabilities tested. Brachytherapy clinical trial starts. YEAR 4First biopsy cases reported. Advanced robotic assistant device tested. First brachytherapy cases reported. Integrated system with more advanced biopsy capabilities enters trial. Integrated system with more advanced brachytherapy capabilities trial. Regulatory approval sought for basic device and system. YEAR 5System with full functionality (deluxe version) tested. Fully functional biopsy and brachytherapy systems enters clinic. First brachytherapy outcome data reported. Clinical trials proceed. FDA 510K commercialization approval for basic device and system.
SPECIFIC AIM TASKS BY GRANT YEAR (taken from grant text):
Aim 1 - Robotic Assistant: Develop a remotely actuated mechanical device to deliver needles into the prostate, across the skin and perineum, inside MRI scanner, independently of the magnet configuration and field strength. Also develop control and image guidance to maneuver the device.Task 1.1: Basic Needle Placement Robot [Y1Y4] Task 1.2: Advanced Needle Driving [Y2Y5] Task 1.3: Robot Control and Image Guidance [Y1Y4]Aim 2 - Modeling and Planning: Develop intra-operative image analysis, anatomical modeling, and planning techniques to allow for optimized treatment and biopsy plans.Task 2.1: Predictive Compensation of Target Motion [Y2Y5] Task 2.2: Seed Recognition [Y2Y4] Task 2.3: Inverse Dosimetric Planning [Y2Y3]Aim 3 - System Integration: Integrate the robotic assistant (Aim-1), image processing, modeling and planning capabilities (Aim-2) in an interactive system suitable for human trials.Task 3.1: Workflow Design [Y1Y4] Task 3.2: System Architecture [Y1] Task 3.3: Software Implementation [Y1Y3]Aim 4 - Clinical Evaluation: Evaluate the novel features and the integrated system clinically in two MRI-guided interventions, namely prostate biopsy and low-dose-rate permanent seed brachytherapy. These will be evaluated in closed and open bore-MRI systems. We will demonstrate the safety and efficacy of MRI-guidance in prostate biopsy relative to conventional biopsy techniques, such as Transrectal Ultrasound (TRUS) guided biopsy. In the case of prostate cancer treatment, clinical outcomes, including safety, efficacy, acute GI/GU toxicity profiles, early PSA monitoring, post-implant dosimetric assessment, and quality of life will be evaluated.Task 4.1: Clinical Trial in Core Needle Biopsy [Y3Y5] Task 4.2: Clinical Trial in Low-Dose-Rate Permanent Seed Brachytherapy [Y3Y5] TASKS LISTSTasks for Year 1:1. Create overall system development plan and workflow;2. Develop requirements specifications;3. Define architectural requirements;4. Define data structures and formats;5. Development GUI mockups;6. Create design documentation including coding standards,7. Develop software code for system modules (image data acquisition (MR & US), data handling, image fusion, treatment planning);Tasks for Year 2:8. Initiate module testing for system functionality;9. Begin software module integration;10. Continue software development/implementation;11. Complete initial system integration (image acquisition software, data handling software, planning software, robot control);12. Initiate integrated system testing. Publications/Conference Workshops Acknowledging both the BRP and the U41 Grants:Journal Publications:1. S. P. DiMaio, S. Pieper, K. Chinzei, N. Hata, S. J. Haker, G. Fichtinger, C. M. Tempany and R. Kikinis. Robot-assisted Needle Placement in Open-MRI: System Architecture, Integration and Validation. Journal of Computer Aided Surgery, 2007. (In press) 2. S. J. Haker, R. V. Mulkern, J. R. Roebuck, A. Szot Barnes, S. P. DiMaio, N. Hata, C. M. C. Tempany. MR Guided Prostate Interventions Topics in Magnetic Resonance Imaging. October 2005; Volume 16(5):355-68. 3. Xiong L, Viswanathan A, Stewart AJ, Haker S, Tempany CM, Chin LM, Cormack RA. Deformable structure registration of bladder through surface mapping. Med Phys 2006; 33 (6) 1848-56 4. Mulkern RV, Szot-Barnes A, Haker SJ, Hung YP, Rybicki FJ, Maier SE, Tempany CMC. Biexponetial characterization of prostate tissue water decay curves over an extended b-factor range. Mag Res Imaging 2006 (24) 563-568 5. Zhang J, Loughlin KR, Zou KH, Haker S, Tempany CMC. The Role of Endorectal Coil MRI in the Management of Patients with Prostate Cancer and in Determining Radical Prostatectomy Surgical Margin Status: A Report of a Single Surgeons Practice. Urology (in press).Conference Publications:6. S. P. DiMaio, G. S. Fischer, S. J. Haker, N. Hata, I. Iordachita, C. M. Tempany, R. Kikinis, G. Fichtinger: A system for MRI-guided Prostate Interventions. Proceedings of IEEE / RAS-EMBS International Conference on Biomedical Robotics and Biomechatronics, February 20-22, 2006 Page(s):68  73. 7. G. S. Fischer, I. Iordachita, S. P. Dimaio, G. Fichtinger: Design of a Robot for Transperineal Prostate Needle Placement in MRI Scanner. IEEE International Conference on Mechatronics, July 2006: Page(s):592  597. 8. Jochen Von Spiczak, Eigil Samset, Simon DiMaio, Gerhard Reitmayr, Dieter Schmalstieg, Catherina Burghart, Ron Kikinis: Device Connectivity for Image-Guided Medical Applications. Proceedings of Medicine Meets Virtual Reality 15  in vivo, in vitro, in silico: Designing the Next in Medicine, February 2007; Volume 125: Pages 482-484. 9. J. von Spiczak, E. Samset, S. DiMaio, G. Reitmayr, D. Schmalstieg, C. Burghart, R. Kikinis: Multi-Modal Event Streams for Virtual Reality. Proceedings of the Conference on Multimedia Computing and Networking, February 2007. Conference/Workshop Abstracts:10. Gregory S. Fischer, Simon P. DiMaio, Iulian Iordachita, and Gabor Fichtinger: Robotic Assistant for MR-Guided Prostate Biopsy. 7th Interventional MRI Symposium, Leipzig, Germany, 2006. 11. J. von Spiczak, E. Samset, D. F. Kacher, F. A. Jolesz, S. P. DiMaio: A voice command interface for real-time interventional MR imaging. Annual Meeting of the International Society for Magnetic Resonance in Medicine, 2006. 12. N. Hata, P. Blumenfeld, S. P. DiMaio, K. Zou, C. M. C. Tempany: Needle placement accuracy in MRI-guided biopsy of the prostate. Annual Meeting of the International Society for Magnetic Resonance in Medicine, 2006.

National Institute of Health (NIH)
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Biotechnology Resource Cooperative Agreements (U41)
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