Recognizing a need for wider access to the technology, researchers at Vanderbilt University developed a benchtop pre-clinical focused ultrasound (FUS) system and have made the “Do It Yourself” instructions available for free.
With 18 different mechanisms of action, FUS is evolving into a multifaceted platform tool that can be used to deliver drugs, disrupt the blood-brain barrier, enhance immunotherapy, and more. Despite seeing increased research interest in the field, Charles Caskey, PhD, and Will Grissom, PhD, at Vanderbilt University’s Institute of Imaging Science observed that access to FUS equipment was limited because of its technically difficult configuration and the relatively low number of commercial machines installed worldwide.
To address this problem and help other researchers and clinicians who are interested in studying the technology, these scientists worked with their colleagues in Biomedical Engineering and Computational and Physical Biology to design and publish “Do It Yourself (DIY)” hardware blueprints and open-source software. Now, other researchers can build their own systems to conduct pre-clinical MR-guided FUS studies.
“The lack of well-described, accessible, pre-clinical focused ultrasound systems limits progress and decreases repeatability of new developments,” said Dr. Caskey. “Our open-source system can deliver repeatable, precise, and quantifiable thermal and mechanical focused ultrasound over an extended period in small animals.”
When built and in operation, Vanderbilt’s DIY system—with its hardware instructions and downloadable software—allows fine control over FUS-induced temperature rise in a small animal model. It includes MR temperature feedback and closed-loop control of each sonication. The Solidworks hardware drawings and software can be used on any small animal MRI system and are available on GitHub and on the VUIIS website.
Heavily based in engineering, the Vanderbilt FUS group designs hardware, writes software, creates cross-disciplinary research projects, and explores multiple indications. With projects to study neuromodulation, whole brain temperature mapping, breast cancer immunomodulation, pancreatic cancer, and uterine fibroids, this world-class research facility is quickly becoming one of the prominent fixtures in the field.
Former Virginia Tech President Elected to Foundation Board
Charles Steger, PhD, who served as the President of Virginia Tech from 2000 to 2014 and as a member of our Council for the past year, has now been elected to the Foundation’s Board of Directors.
“At this stage in my life and career, I want to dedicate my time to making a difference in improving the human condition,” said Dr. Steger. “I can think of no better use of my life energy than to be involved with the Foundation advancing development of focused ultrasound.”
“We are honored to have such a visionary leader and innovator join our Board,” said Chairman Neal F. Kassell, MD. “We look forward to Charles’ contributions as we fuel research and work to educate and empower the next generation to shape the future of medicine.”
UVA leaders gathered at the FUS Center with William Howell, Virginia Speaker of The House, and Delegates Steve Landes and David Toscano to thank them for their support.
State Invests $4 Million in UVA FUS Center
The Commonwealth of Virginia has dedicated $4 million in the state budget over the next two years to support the University of Virginia (UVA) Focused Ultrasound Center. This investment will have an incredible impact, accelerating progress toward new cures, attracting additional funding, and stimulating the economy. The additional resources will enable UVA to remain on the cutting edge of focused ultrasound progress, continuing research in movement disorders and expanding into areas like enhancing immunotherapy for breast cancer and treatment for epilepsy, back pain, osteoarthritis, thyroid nodules, prostate cancer and more.
UVA is at the forefront of progress, having been the first site in the world to use the technology to treat a patient with essential tremor and the first in the US for Parkinson’s disease.
Vibhor Krishna, MD, SM, Assistant Professor at the Center for Neuromodulation in the Departments of Neurosurgery and Neuroscience at Ohio State University
Webinar Describes New Brain Targeting Method
For focused ultrasound procedures to treat essential tremor, neurosurgeons currently use conventional MR imaging to identify specific anatomic landmarks and then validate the actual target—the ventral intermediate (VIM) nucleus—during the treatment process.
In his May 11 webinar, Vibhor Krishna, described a new tractography-based method (“T-VIM”) for imaging the actual neural pathways in the VIM, allowing him to more precisely target this area of the brain. Could these new imaging sequences lead to better outcomes? Could this method also be applied to other brain targets for the treatment of Parkinson’s disease or epilepsy?
"We are very pleased with the quantity and quality of the abstracts. The diversity in research continues to increase as the field expands." – Foundation Chairman Neal F. Kassell, MD
Record Number of Symposium Abstracts Received, Preliminary Program Now Available
This year’s 5th International Symposium will continue to be the world’s leading forum for focused ultrasound, with around 200 abstracts submitted from 18 countries. Neurological research tops the list, followed by liver/pancreas and the breast. Novel research areas are represented, including immunotherapy, neuromodulation, and cardiovascular applications. The conference will also dedicate a half day to issues affecting commercial success.
Abstract review and selection is now underway, and acceptance notifications will be sent in late June.
The meeting kicks off with a Welcome Reception on Sunday, August 28. The following morning, plenary sessions and panels begin. Be sure to catch the Evening Poster Session and Young Investigator Spotlight on Tuesday. We have also built in ample time for ad hoc meetings and collaboration, a central goal of the Symposium.
Many patients credit focused ultrasound with giving them new hope for the future. To help bring their experiences to life, the Foundation recently launched a video series of patient stories. Hear directly from the individuals who have undergone focused ultrasound as they describe their symptoms, why they chose the treatment, and how they are doing today.
Foundation Welcomes Development Officer Susan Noll
The Foundation has recruited Susan Noll as Development Officer, who joins the team to promote the Foundation’s unique philanthropy model. “Given the experience of my family members as health professionals and patients, I have a real passion for advancing medicine,” said Susan. “I am excited to apply my expertise and passion to helping the Foundation reach out to donors and other stakeholders to help make this technology more accessible to patients.”
"Susan has the communication and networking skills to connect our organization with those whose interests match ours." – Foundation Chairman Neal F. Kassell, MD
"Urologists are looking at the data and listening to the differing opinions. They are interested in studies comparing the side effects profiles of HIFU to cryotherapy, laser ablation, and radiation." – Foundation Chief Medical Officer Tim Meakem, MD
After four expert presentations on the FDA path to approval, the Canadian experience, the European experience, and an overview of instrumentation and techniques, the session concluded with a panel discussion on patient selection for focal treatment, hemi-ablation, and whole gland ablation.
What are the metrics that measure the rate of uptake of new and disruptive medical technologies? Jonathan Pomeraniec and colleagues at the University of Virginia outlined these parameters, including theories behind adoption and diffusion, in a review published this month in BMJ Innovations. “Focused Ultrasound and Metrics of Diffusion of Disruptive Medical Innovation” uses Gamma Knife radiosurgery and the da Vinci systems as proxies for developing metrics for the adoption of FUS.
How do changes in focused ultrasound frequency affect anatomic specificity and efficacy in neurostimulation? Researchers in the US and China both studied this question in mice. A group in France has performed an in vivo, beating heart feasibility study for using focused ultrasound to perform cardiac ablation. Chinese researchers found improved short-term survival in patients treated with focused ultrasound plus chemotherapy when compared to chemotherapy alone for patients with unresectable pancreatic cancer.
JTU Article of the Month – Lumbar Spine Facet Evaluation
To improve the safety and feasibility profile for using focused ultrasound to treat arthritis and other degenerative conditions in the lumbar spine, researchers at UCSF tested various MRI protocols (pulse sequences) for assessing lumbar facet joint lesions after treatment. Are the MRI images adequate for this sensitive procedure?
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"Thanks to this favorable decision, Canadian essential tremor patients suffering significant disability now have access to a new incision-less treatment option that offers immediate results." – Richard Schallhorn, Insightec’s VP of Neurosurgery
Insightec’s FUS System Approved in Canada for Tremor
Health Canada has approved Insightec’s Exablate Neuro for the treatment of essential tremor (ET). The system is currently under expedited FDA review in the United States. In addition to Canada, this focused ultrasound system is approved in Europe to treat ET, Parkinsonian tremor, and neuropathic pain; and in Korea for ET, depression, neuropathic pain, OCD, and Parkinsonian tremor.
Insightec’s Canadian regulatory application is based on a pivotal trial funded through a partnership between Insightec, the BIRD (US-Israel Binational Industry R&D) Foundation, and the Focused Ultrasound Foundation.
Panel (L to R): Antonio Chiocca, Maurice Ferré, David Lee, Amy Pollack, Ralph Weissleder
Antonio Chiocca, Neurosurgeon-in-Chief at Brigham and Women’s Hospital, expressed that non-invasively opening the BBB would be a game-changing opportunity for cancers in the brain and other diseases.
Health Leaders at World Medical Innovation Forum Excited About FUS
Insightec CEO Maurice Ferré, MD, spoke on focused ultrasound as a breakthrough device to treat cancer to more than 1,000 senior healthcare leaders at the 2016 World Medical Innovation Forum in Boston. Experts from around the globe were excited about its potential to revolutionize treatment.
“We were able to generate a lot of interest in how focused ultrasound can interact with and facilitate delivery of drugs,” said Dr. Ferré. “Given the momentum behind immunotherapy, there was particular enthusiasm about how focused ultrasound can open the blood-brain barrier (BBB) to help deliver large antibodies into the brain.” The audience was very engaged, asking how soon the technology would be available and encouraging device makers to collaborate with pharma, not just for cancer, but also movement disorders and other serious conditions.
With the intention to globally expand their focused ultrasound market, Insightec has signed a non-binding Letter of Intent with Siemens to develop compatibility between Insightec’s MRI-guided Exablate system and Siemens’ MRI scanners. Exablate is currently compatible with GE’s MRI platform, so the new partnership would increase the number of hospitals that could connect focused ultrasound with existing imaging equipment.
SonaCare Medical Announces Strategic Partnerships
SonaCare Medical and MIM have signed a licensing agreement to incorporate MIM’s “Symphony” fusion technology onto the Sonablate prostate tissue ablation platform. The technology allows the Symphony-annotated MRI data to be fused with Sonablate’s intraoperative ultrasound images to improve targeting.
Additionally, SonaCare has partnered with Philips' Invivo to combine Invivo's UroNav fusion biopsy system with the Sonablate 500 to help physicians locate and track targets for prostate HIFU ablation.
NIH and FDA Release Clinical Trial Protocol Template
A new tool will be available for researchers or companies who are looking to file an investigational device exemption (IDE). The National Institutes of Health (NIH) and US Food and Drug Administration (FDA) Joint Leadership Council have released the first draft of a protocol template for NIH-funded Phase II and III clinical trials done in support of an investigational new drug application (IND) or IDE. The 61-page template is designed to help clinical investigators make clinical trials more efficient and potentially save development time and money. It is available from NIH with instructions and examples included, and as a blank template.