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This month’s research report highlights the impact of focused ultrasound across multiple medical specialties. As biomarkers have become critical tools for early detection and treatment of malignant and benign tumors, focused ultrasound could help researchers discover them sooner. A Stanford University team published their findings on a study co-funded by the Foundation. Neuromodulation is a promising non-narcotic solution for treating various types of pain. A University of Washington group conducted a pilot study using focused ultrasound neuromodulation to identify which nerves could be the source of pain in patients with unilateral limb amputations. And finally, it might be possible to use focused ultrasound plus microbubbles to open the blood-brain barrier (BBB) outside of an MRI suite. Biomedical engineers at Columbia University worked to provide effective alternative imaging techniques.
At Tokyo Women’s Medical University in Japan, Takaomi Taira, MD, PhD, has begun a focused ultrasound trial that is pioneering an approach for treating the symptoms of Parkinson’s disease. He is targeting the pallidothalamic tracts in the brain, an approach that he believes is superior to other targets due in part to their location.
A new Parkinson’s disease clinical trial is currently underway in Madrid, Spain.
Led by José Obeso, MD, the double-blind trial will investigate the safety and efficacy of using Insightec’s Exablate Neuro focused ultrasound device to treat the cardinal features of Parkinson’s disease. Unlike previous studies that treated the levodopa-induced dyskinesia in Parkinson’s disease by targeting the globus pallidus region of the brain, this trial aims to treat the part of the brain called the subthalamic nucleus.
The Foundation has recently funded four research studies. Three of the projects – at Ohio State University, Weill Cornell Medical Center, and Stanford University – aim to improve the way focused ultrasound is used to treat brain disorders. The fourth – at the University of Virginia – will investigate whether focused ultrasound can improve the effectiveness of chemotherapy in breast cancer patients. The Foundation has recently funded four research studies. Three of the projects – at Ohio State University, Weill Cornell Medical Center, and Stanford University – aim to improve the way focused ultrasound is used to treat brain disorders. The fourth – at the University of Virginia – will investigate whether focused ultrasound can improve the effectiveness of chemotherapy in breast cancer patients.
“Revolutionizing Ultrasound Applications for Treating Disease” was the title of a scientific session held during the annual meeting of the American Association for the Advancement of Science (AAAS) February 15–19, 2018, in Austin, TX. The workshop proved to be an auspicious opportunity to raise awareness of therapeutic ultrasound with a large and diverse audience of international scientists. The 90-minute session offered attendees a review of new therapeutic applications for ultrasound that are “revolutionizing the treatment of disease: surgery without cutting, drug delivery without systemic exposure, and permeation without tearing.” It also touted the technology’s ability to improve patient outcomes and lower the cost of care. For the technically oriented crowd, the session described the science behind acoustic wave manipulation and the latest research in key applications.
How are the first essential tremor patients treated with focused ultrasound doing now, two years later? Can the right carrier improve drug delivery to the brain? The January Research Roundup answers these questions and includes a technical paper that describes an acoustic lens that might improve focused ultrasound treatments in the brain.
The Biomedical Engineering Society (BMES) held their annual meetingOctober 11-14, 2017 in Phoenix, AZ. Nine focused ultrasound presentations were selected for the agenda, and they covered topics such as the use of pulsed focused ultrasound to modulate an immune response in breast and melanoma tumor models; the use of focused ultrasound and microbubbles for cancer therapy; a new idea for prostate cancer treatment; and the development of novel tools for studying focused ultrasound for brain neuromodulation. Two teams developed simulation tools for transcranial research. The Foundation funded the Brigham and Women’s/Harvard Medical School neuromodulation study.
Karun Sharma, MD, PhD, Director of Interventional Radiology, and colleagues at Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System in Washington, DC, have completed their clinical trial to treat benign but painful bone tumors (osteoid osteoma) in children. They have published the results, which demonstrated safety and efficacy for focused ultrasound, and then compared the results to a historical control group of children treated with radiofrequency ablation (RFA) in The Journal of Pediatrics. Children’s National was the first children’s hospital in the US to conduct a clinical trial using focused ultrasound to treat pediatric osteoid osteoma with the Philips V2 Sonalleve system.
Murat Karabiyikoglu, MD, MBA – a former life-science investment professional with the credentials of a former clinically active neurosurgeon – has joined the Foundation as a research fellow on a J-1 Research Visa, where he will participate as a member of the Foundation’s Brain Technical Research Team as well as conduct independent research projects to help make the case for commercial adoption of the technology.
Researchers at Sunnybrook Health Sciences Centre in Toronto have begun a new clinical trial to evaluate the feasibility and safety of focused ultrasound to alleviate symptoms in patients with refractory obsessive-compulsive disorder (OCD). To date, three of six patients have been treated.
The University of California, San Francisco (UCSF) and Stanford University are currently enrolling participants in a comparative trial of osteoid osteoma in pediatric patients. This study will compare CT-guided radiofrequency ablation (CTgRFA) with high-intensity focused ultrasound, comparing pain reduction between the two treatments along with procedural experience and quality of life during recovery.
The talented group of interns participating in the sixth year of the Foundation’s summer internship program included four college students who worked on projects ranging from focused ultrasound patient registries to the use of 3D-printed lenses for transcranial FUS. They were recently able to showcase their projects during a lunch time presentation to Leigh Middleditch (pictured right, with three of the four interns), who is on the Board of the Claude Moore Charitable Foundation, the generous funder of this summer program.
The Foundation recently spoke with Rick Schallhorn, Vice President of Neurosurgery, and Xen Mendelsohn Aderka, Vice President of Marketing, for Israel-based Insightec, the company behind focused ultrasound technology for essential tremor (ET). They share their efforts to increase awareness for the focused ultrasound treatment for ET.
The 17th quadrennial meeting of the World Society for Stereotactic and Functional Neurosurgery (WSSFN) was held June 26-29 in Berlin. Data from two key Foundation-funded studies were presented at the meeting, including the blood-brain barrier opening for Alzheimer’s disease, and the Parkinson’s dyskinesia study co-funded by the Michael J. Fox Foundation for Parkinson’s Research. “The international neurosurgical community is paying attention to focused ultrasound,” said Focused Ultrasound Foundation Chairman Neal F. Kassell, MD.
The Foundation strives to cultivate the next generation of scientists working in the field of focused ultrasound. We are proud to announce that three such young researchers, Guillaume Maimbourg, Sarah Brüningk, and Amirah Aly, have earned awards for their work. Meanwhile, a former Foundation intern, Changzhu Jin, has earned his PhD.
Two proposals have been selected to receive Foundation funding in the 2nd quarter of 2017.
James Keenan, CEO of Artenga, Inc., a Canadian life sciences company, will partner with Sunnybrook Research Institute and the University of Helsinki to investigate “MRgFUS Blood-Brain Barrier Drug Delivery with AAV2 Gene Therapy Microbubble Drug Conjugates.” The team proposes to develop a novel microbubble-drug conjugate with an adeno-associated virus and then use focused ultrasound to deliver the gene therapy to the regions of the brain affected by Parkinson's disease.
Frank Wolfram, PhD
In Germany, Frank Wolfram, PhD, and his team at SRH Waldklinikum Gera have been funded to determine “Accessibility and Benefit of Focused Ultrasound Treatment for Inoperable Lung Cancer Patients, A Retrospective Analysis.” Now that their preliminary data have shown the feasibility for focused ultrasound to treat lung cancer on large animal models via intentional One Lung Flooding (OLF). This study will analyze the charts of inoperable patients (70% of all lung cancer patients) to map tumor location and volume, classify and analyze the pulmonary function to estimate their accessibility to OLF, and therefore determine the future clinical potential of FUS for treatment of primary lung cancer.
On April 24, John Snell, PhD, Technical Director of the FUSF Brain Program, and Pejman Ghanouni, MD, PhD, from Stanford University, led a continuing education course on MR-guided Focused Ultrasound in the Brain. Designed for physicists and engineers, the session aimed to introduce new or emerging MR methods and applications and discuss their clinical potential.
Charlottesville, VA - May 2, 2017 - Researchers at Sunnybrook Health Sciences Centre in Toronto have begun the world’s first clinical trial evaluating the feasibility and safety of opening the blood-brain barrier (BBB) in patients with Alzheimer’s disease (AD) utilizing focused ultrasound.
Researchers at Nicklaus Children’s Hospitalin Miami, Florida have performed the first procedure in a pediatric and young adult brain tumor study. The trial aims to demonstrate feasibility and safety of using focused ultrasound to ablate a variety of benign tumors located in the central part of the brain in ten patients, ages 8 to 22. Left untreated, these tumors often cause seizures, cognitive delays, or other complications as they grow.
Parkinson’s disease damages dopamine neurons in the part of the brain called the substantia nigra (SN). Scientists hypothesize that these damaged cells can be repaired, and previous studies found that DNA segments that were introduced through the intranasal route of administration could produce a dopamine cell survival factor called glial cell derived neurotrophic factor (GDNF) that protected these cells in the SN. Researchers at Northeastern University, Brigham and Women’s Hospital, and Copernicus Therapeutics conducted a study to use focused ultrasound and microbubbles to improve on this concept.
The Society of Interventional Radiology (SIR) held its 2017 Annual Meeting in Washington, DC, March 4-9. Three focused ultrasound abstracts were selected for SIR 2017: two oral presentations and one poster. Topics covered include vascular malformations, pediatric osteoid osteoma, and introducing junior radiologists to the field of focused ultrasound. An NIH poster on prostate imaging prior to treatment also mentioned focused ultrasound.
Patients with benign breast tumors may be eligible for a new focused ultrasound–based investigational treatment as part of a pivotal, multi-center clinical study. The trial began last month at the University of Virginia (UVA) Medical Center.
The Focused Ultrasound Foundation is pleased to designate a new Center of Excellenceat the French National Institute for Health and Medical Research (INSERM) in Lyon, France. INSERM Unit 1032, the Laboratory of Therapeutic Applications of Ultrasound (LabTAU), is located within a large medical and research community and conducts significant translational and clinical research with a multi-disciplinary, highly qualified, and complementary team of physicians and scientists.
Two competitions are underway to recognize leaders in research innovation and entrepreneurship. We encourage those in the focused ultrasound community to apply.
This month, exciting research was published involving focused ultrasound to open the blood-brain barrier to deliver drugs to metastatic brain tumors, treat a rare type of spinal bone cancer, and reduce eye pressure in glaucoma patients.
In a pre-clinical study, a Taiwanese group used focused ultrasound to increase the amount of a chemotherapy drug delivered across the blood-brain barrier to brain metastases. See Pulsed-wave low-dose ultrasound hyperthermia selectively enhances nanodrug delivery and improves antitumor efficacy for brain metastasis of breast cancer in Ultrasonics Sonochemistry.Collaborators in Oxford, UK, present the outcomes from four cases and announce the start of a clinical trial in using focused ultrasound to treat sacral chordoma, a rare type of spinal bone cancer. See High-intensity focused ultrasonic ablation of sacral chordoma is feasible: a series of four cases and details of a national clinical trial in the British Journal of Neurosurgery.Two glaucoma centers in Italy successfully treated 30 patients with focused ultrasound to reduce intraocular pressure using Eye Tech Care’s EyeOP1 device. See High-intensity focused ultrasound treatment in patients with refractory glaucoma in Graefe's Archive for Clinical and Experimental Ophthalmology.
Abstracts from the Foundation’s 2016 Symposium have now been published in a special supplement to the Journal of Therapeutic Ultrasound. The presentations covered neurological, liver/pancreas, breast, immunotherapy, cardiovascular, and emerging applications, representing the great progress made in the past decade and the promising future for the field.
Read the abstracts >
More than 40 experts from around the world gathered for the Focused Ultrasound and Immunotherapy Summit, held in partnership with the Cancer Research Institute on October 14. The group met to critically evaluate the current body of evidence, assess the value of ongoing work, and create a roadmap of projects to address any remaining gaps or questions.
The Symposium’s scientific presentations demonstrated that significant progress is being made in advancing FUS as a solution in many fields of medicine, utilizing a variety of biomechanisms. Here are some of the highlights:
This year, two returning students were met by a couple of new faces to round out our talented group of summer interns.
In recognition of their leadership in advancing focused ultrasound research for the brain, the Foundation is pleased to designate the University of Maryland as a Center of Excellence.
The prestigious New England Journal of Medicine published the pivotal study that led to the approval of Insightec’s Exablate Neuro focused ultrasound system to treat essential tremor (ET).
Sharon Samuels shares her struggle with essential tremor and gets her quality of life back after focused ultrasound treatment.
The ET patients treated in this study achieved significantly reduced unilateral hand tremor that proved durable at 12 months. The procedure also reduced disability and improved quality of life one year after treatment. The study was conducted at eight centers and led by University of Virginia neurosurgeon Jeff Elias, MD.
“This study represents a major advance for neurosurgery, treatment of brain disease and specifically the treatment of essential tremor,” Dr. Elias said. “For the first time in a randomized controlled trial, we have shown that ultrasound can be precisely delivered through the intact human skull to treat a difficult neurological disease.”
“This publication further affirms to the medical community that focused ultrasound is a safe and effective alternative to treat the brain without incisions or radiation,” says Foundation Chairman Neal Kassell, MD. “Now that Insightec’s system is approved by the FDA, the important next step is to secure the appropriate levels of reimbursement so that leading medical centers will invest in this technology and make it widely available to patients seeking non-invasive options for their tremors.”
Given the challenges of accessing the brain and the high cost, complications, and limitations of some current approaches, we believe that focused ultrasound has the potential to revolutionize the treatment of many brain disorders and ultimately to open up opportunities to rapidly advance applications throughout the body.
The idea of using focused ultrasound to treat tremors was conceptualized at the Foundation's first brain workshop in March 2009. The Foundation then helped organize and fund a pilot study with Insightec and the University of Virginia that served as the predicate for this larger pivotal study.
The pivotal study was funded by a partnership between the Focused Ultrasound Foundation, Insightec and the BIRD (Israel-US Binational Industrial R&D) Foundation.
Read the University of Virginia's press release >The pivotal trial took place at the following sites:
Cyril Lafon, PhD, joins the Foundation as the 2016-2017 Richard Merkin Visiting Fellow. Dr. Lafon is the Director of LabTAU, a research laboratory of INSERM – the French National Institutes of Health – located in Lyon. He was selected based on his innovative ideas and proven track record in developing focused ultrasound devices for patient use. We sat down with Cyril to discuss how he became interested in focused ultrasound and his work.
Patient selection for high intensity focused ultrasound (HIFU) prostate treatment was featured as one of the opening plenary sessions for the 2016 Annual Meeting of the American Urological Association, held earlier this month in San Diego.
Charles Caskey, PhD, and Will Grissom, PhD, at Vanderbilt University’s Institute of Imaging Science address questions about their site and its important focused ultrasound work. In May 2016, the team at Vanderbilt debuted DIY hardware blueprints and open-source software so that other researchers can build their own systems to conduct pre-clinical MR-guided FUS studies.
Scientists from the Foundation’s Brain Technical Program have joined with the University of Utah on a project to expand the range of neurological disorders that can be treated with focused ultrasound.
This month’s roundup includes studies in brain disorders, immunology, and women’s health. Is it feasible to use focused ultrasound to treat temporal lobe epilepsy? Can scientists deliver GDNF plasmids across the BBB to potentially treat Parkinson’s disease? How does focused ultrasound compare to DBS in treating ET?
Gene Therapy and Immunology
The Focused Ultrasound Foundation is committed to advancing the use of FUS to open the BBB and treat a range of neurological conditions. In addition to supporting research through our funding awards, we have organized several workshops exploring this topic, including a September 2013 BBB Workshop, a February 2015 Immunotherapy Workshop, and a September 2015 Alzheimer’s Workshop.
Understanding the way that Alzheimer's disease cripples the brain and then designing an affordable treatment is what drives the work of Jürgen Götz, PhD.
Dr. Wladyslaw "Wady" Gedroyc, MBBS, MRCP, FRCR is a Consultant Radiologist at St. Mary's Hospital, Imperial College NHS trust and has been a champion of focused ultrasound for 16 years. He has treated more than 600 patients, mostly women with uterine fibroids, at St. Mary’s. The center now treats about one uterine fibroid patient per week, and they are continuing to explore other uses of the technology.
Wladyslaw Gedroyc Leading Innovation
St. Mary’s Hospital in London will soon have the first focused ultrasound brain system in the UK. Leading radiologist Wladyslaw (Wady) Gedroyc recently secured funding from the Imperial College Hospital Charity for the Insightec ExAblate Neuro system.
More than 180 international focused ultrasound experts gathered in London at the Royal Geographic Society for the 3rd European Symposium on Focused Ultrasound Therapy, held October 15-16.
Advances in focused ultrasound brain treatment are ongoing. Efforts to expand the treatment envelope in the brain are addressed in this month’s research roundup.
Two projects have been selected for funding for the 3rd quarter of 2015. The first is Dr. James Drake’s work at the Hospital for Sick Children in Toronto. His group will establish an international database for pediatric focused ultrasound treatment. In urology, Dr. George Schade at the University of Washington will be assessing the use of histotripsy for treating renal tumors.
Seung-Schik Yoo, PhD, MBA, is making breakthroughs in using focused ultrasound to induce functional neuromodulation of the brain and peripheral nervous system. With his global collaborative partners, he is experimenting with various FUS parameters to move the field closer to achieving this important milestone in humans.
Nathan McDannold, PhD, has put tremendous effort into the brain applications of focused ultrasound and worked with Kullervo Hynynen to become one of the first to open the blood-brain barrier. His work in drug delivery and neurodegenerative diseases is sure to change the way that medicine is practiced. A medical physicist, he has been a participant in the care of every focused ultrasound patient treated at BWH since 1996.
Radiologist Clare Tempany, MD, has been a Vice Chair for Research since 2007. She manages the National Center for Image Guided Therapy, a Focused Ultrasound Foundation Center of Excellence. The National Center is divided into several different research areas, including the Surgical Planning Laboratory directed by Seung-Schik Yoo, PhD, and the Focused Ultrasound Laboratory directed by Nathan McDannold, PhD. All combined, the teams total 40 to 50 total staff, including faculty, students, post-docs, and visiting students and faculty.
The Foundation hosted a workshop in Bethesda September 17-18 to discuss the state of the field, current challenges, and future research directions for using focused ultrasound to treat Alzheimer’s disease.
This pioneer seeks to ultimately see the translation of this discovery to the medical clinic, providing life-changing non-invasive treatment for diseases such as blood clots, liver tumors, brain cancer, and congenital heart disease. We interviewed her in July 2015 for a closer look at her research:
Dr. Zhen Xu, PhD, and her group at the University of Michigan recently completed a Foundation-funded study that evaluated the use of histotripsy for thrombolysis—dissolving unwanted blood clots.
Recently published focused ultrasound (FUS) research includes a comprehensive review of its use in treating the brain, including central neuropathic pain, essential tremor, Parkinsonian tremor, brain tumors, and temporary disruption of the blood-brain barrier for targeted drug delivery. Physicians and scientists in Europe also published collaborative reviews on using FUS for breast cancer treatment and uterine fibroids. Additionally, ultrasound contrast agents may enhance the FUS treatment of uterine fibroids.
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