Charlottesville, Va., October 13, 2021 – In a first-in-world clinical trial, researchers at Sunnybrook Health Sciences Centre in Toronto, Canada, have demonstrated that magnetic resonance (MR)-guided focused ultrasound can be used to safely deliver antibody therapy to breast cancer that has metastasized to the brain.
Continue reading >
The IEEE International Ultrasonics Symposium (IUS) 2021 was held as a virtual meeting September 11-16, 2021.
The Cardiovascular and Interventional Radiology Society of Europe (CIRSE) 2021 Summit was held virtually September 25-28, 2021.
The Foundation thanks Joan Vidal-Jové, MD, PhD, of the Interventional and Surgical Oncology department at the Comprehensive Tumor Center Barcelonain Barcelona, Spain, for providing this case report.
In November 2013, a 67-year-old male with stage 4 colon cancer underwent surgical resection of a part of his colon containing cancer. During the operation, he was noted to have hepatic metastases. After recovery from his colon surgery, the patient was started on chemotherapy. In 2014 and 2015, he underwent two separate open surgeries to remove liver masses, and chemotherapy was continued. From 2015 to 2018, his cancer was in remission, and he was maintained on adjuvant chemotherapy. In May 2018, during routine follow-up, the patient showed marked progression of his liver tumors in addition to new lung masses. Due to these findings, he was started on a different chemotherapy regimen plus an immunotherapy drug. In July 2018, three of the patient’s liver masses were treated with thermal ablation by ultrasound-guided, high-intensity focused ultrasound (HIFU). He had a partial response to this treatment, but, unfortunately, his disease continued to progress, and he was maintained on the chemotherapy plus immunotherapy regimen. In April 2019, an MRI of the patient’s abdomen revealed countless liver masses that had increased in number and size since his last evaluation (Figure 1). The patient received an evaluation by the Tumor Board at Comprehensive Tumor Center Barcelona, and his inclusion in a clinical trial – the THERESA study – was approved. The THERESA studyis a first-in-human clinical trial sponsored by HistoSonics, Inc. to establish the safety and efficacy of their histotripsy device to treat liver tumors. The patient was not considered a candidate for other surgical or locoregional therapies.On May 13, 2019, the patient underwent histotripsy-mediated ablation of a 1.2 cm x 1 cm lesion in his liver. No adverse events occurred during or after the procedure, including no pain. In the weeks following the procedure, lab tests revealed a significant decrease in the value of the tumor marker CEA (Figure 2), and the patient continued to feel well with no pain. Follow up MRI scans at one, four, and eight weeks showed a decrease in size of the targeted, treated lesion as well as a decrease in size of numerous other, non-treated lesions throughout the liver (Figure 3). Immune assessment (CD3, CD4, CD8, IL6, Complement) was equivocal. Following the advice of the patient’s oncologist, a new chemotherapy regime was initiated five weeks after the ablation procedure. After this, both tumor marker levels and the size of the liver lesions continued to decrease. In December 2019, there was progression of the liver metastases and appearance of a new tumor in the colon. New treatment options and clinical trials are still being explored. At present, one year after his treatment with histotripsy and evidence of an abscopal effect, the patient has slow progression of his disease.
Surgical resection is the established first-line treatment for primary and metastatic liver cancer. However, surgical removal with curative intent is only feasible for a minority of patients with liver metastases (10-25 percent) since only a small proportion of patients have tumors that are entirely resectable at presentation.1 Despite the survival advantage of hepatic resection on colorectal cancer liver metastases, relapse is common following curative resection.2 In addition, surgery is an invasive procedure associated with high rates of morbidity and mortality.3Ablation techniques are promising alternatives for those patients who are not eligible for surgical resection or who have failed other therapies. Current ablation methods include non-thermal ablation methods (e.g., percutaneous ethanol injection [PEI] and irreversible electroporation [IRE]) and thermal modalities (e.g., radiofrequency ablation [RFA, microwave ablation [MWA], and HIFU.)4Despite the efficacy of some of these local thermal ablation modalities, significant limitations exist due to their mode of action (thermal tissue destruction). Thermal ablation is inconsistent in tissue with non-uniform heat dissipation patterns, which is common in liver tumors.5 It often results in incomplete tumor necrosis in tissue that is located near major vessels.6, 7 Consequently, the shape and the size of the ablation zone may be unpredictable, and the efficacy of thermal ablation may be restricted.8 In addition, thermal ablation methods are often unsuitable for treating tumors larger than three centimeters due to excessive treatment time and practical ultrasound probe sizes.9-11 Most complications associated with RFA and MWA are consequences related to thermal injury.12 Another limitation of these methods is the lack of imaging feedback during treatment. Thus, CT or MRI evaluates the effect of ablation treatment after the application of thermal treatment while no real-time imaging provides monitoring during treatment.13HIFU is a noninvasive, image-guided, thermal ablation method. Unlike percutaneous thermal modalities, HIFU is completely extracorporeal and lacks the risks of bleeding and tumor seeding with the direct puncture of tumors. HIFU can improve upon other thermal ablation modalities due to its noninvasiveness, real-time feedback, and the ability to scan the focal zone over a large volume.13 As with the other thermal-based methods, HIFU is limited by the heat-sink effect, resulting in reduced efficacy in ablating tissue near major vessels and by extended treatment time for larger liver volumes.13 Another major challenge in the noninvasive treatment of liver tumors using HIFU is rib obstruction, which may result in secondary hot spots near the treatment main focal zone, inducing loss of therapeutic precision and collateral damage.14 Moreover, because of the high ultrasound absorption coefficient at the bone-tissue interface, overheating of ribs and surrounding tissue often results in unwanted tissue damage. Skin burns and subcostal edema have been reported with HIFU ablation cases.15, 16Therefore, developing new strategies in which a liver tumor can be ablated noninvasively and avoiding thermal-related collateral damage and inefficacy would be a major clinical advancement. To address this unmet clinical need, cavitation-based, ultrasound-guided treatment (histotripsy) is a promising option to destroy liver tumors and overcome the limitations of currently available ablation modalities.Histotripsy is a treatment technology that mechanically destroys targeted tissue through the precise targeting of acoustic cavitation.17-19 The ablation system is an image-guided device designed to deliver noninvasive, non-thermal histotripsy for local treatment that has the potential to overcome many limitations of other focal liver tumor treatment options.The Histotripsy Group in the Biomedical Engineering Department at University of Michigan invented and pioneered the development of focused ultrasound histotripsy more than 12 years ago. Starting with their earliest work with the use of microbubbles to cause tissue damage, this group developed histotripsy into a highly controlled and predictable tool to remove unwanted tissue with microscopic precision. In 2010, HistoSonics, Inc. entered into a worldwide exclusive license with the University of Michigan for exclusive rights to the entire portfolio of histotripsy patents and patent applications.Favorable characteristics of histotripsy treatment method include:
An additional potential benefit of histotripsy may be as immunogenic ablation20 if it can be used to stimulate tumor-specific immune responses capable of magnifying the impact of checkpoint inhibition immunotherapy. The characteristics of this cavitation-based ablation likely allow cytokines and metabolites – not destroyed in the tumor micro-environment – to become highly immunogenic and contribute to the abscopal effect, where shrinkage of untargeted tumors occurs secondary to an immune response. The abscopal – or “off target” – effect was first described in patients who were receiving radiation therapy that were noted to have regression of tumors that were in a non-irradiated zone. It describes the ability of localized radiation to initiate an antitumor response that kills cancer cells distant to the primary target. Similar to radiation, focused ultrasound has been shown to produce an abscopal effect in both preclinical and human cancers. When combined with immunotherapy, the abscopal effect could produce a durable treatment response to control or eradicate metastatic cancer.
This case report shows clear evidence of an immunologic relationship between histotripsy ablation and the abscopal effect. A patient with progressive and extensive metastatic disease with a short overall survival prognosis had noticeable shrinkage of non-targeted metastases and is still alive and considering new clinical trial options one year after the histotripsy procedure.In addition, this report highlights the differences between two focused ultrasound modalities. Thermal US guided HIFU was performed previously and obtained a substantial volume ablation but no immune effects. Less volume ablation with histotripsy generated a noticeable abscopal effect, and this data will influence future research assumptions.Histotripsy is a disruptive technology. The non-thermal and noninvasive characteristics of histotripsy offer patients the potential for a tumor treatment with fewer clinical complications and adverse events than currently available ablation methods and surgical procedures. The safety of histotripsy has been demonstrated through rigorous testing including benchtop and both acute and chronic disease preclinical studies. Future clinical trials with the objectives to evaluate technical performance, including acute technical success, while collecting safety-related data are forthcoming. In addition, further clinical trials should continue to explore histotripsy-mediated immune effects in detail. The THERESA Study used an investigative histotripsy device that is not yet commercially available. The THERESA Study is currently ongoing; therefore, data is not considered final.
The Foundation has launched a multicenter, international registry to evaluate focused ultrasound as a treatment option for patients with pancreatic cancer.
Safety and Feasibility of Multiple Blood-brain Barrier Disruptions for the Treatment of Glioblastoma in Patients Undergoing Standard Adjuvant Chemotherapy
Focused ultrasound researchers at Columbia University recently published a paper that is garnering attention in the scientific community and beyond. Available in the Journal of Controlled Release, the group led by Elisa Konofagou, PhD, described their groundbreaking preclinical work using focused ultrasound to deliver targeted gene therapy across the blood-brain barrier (BBB) to restore important nerve pathways that are damaged in Parkinson’s disease.
In May 2018, Foundation scientists released Kranion®, a highly visual and interactive, open-source transcranial focused ultrasound modeling system for conducting research. Kranion® allows scientists to “see” how the paths of focused ultrasound’s invisible sound waves behave as they pass through the skull while aiming for a particular target in the brain.
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.
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.
Two competitions are underway to recognize leaders in research innovation and entrepreneurship. We encourage those in the focused ultrasound community to apply.
Most known for advancing focused ultrasound applications in the brain, Insightec announced that it has earned the CE Mark to treat the prostate. The Exablate Prostate system is now cleared in Europe to treat patients with locally confined prostate cancer. Read Insightec's release below.
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.
The Ontario Health Technology Advisory Committee (OHTAC) has recommended focused ultrasound (FUS) as a possible “cost-effective strategy” and a “safe and effective, noninvasive, uterine-preserving” option for women seeking treatment for uterine fibroids.
After battling breast cancer for 12 years, Cynthia received devasting news; the cancer had spread to her brain. That's when Cynthia and her family turned to a clinical trial investigating the use of focused ultrasound.
InSightec has completed enrollment in the pivotal study of their ExAblate Neuro system for the treatment of essential tremor. Physicians at eight sites worldwide have now treated 76 patients in the trial. The first randomized, controlled trial of unilateral MR-guided focused ultrasound thalamotomy with InSightec’s system began in August 2013 and completed enrollment in September 2014. Results will be submitted to the US Food and Drug Administration (FDA) for regulatory approval of the device. The pivotal study was designed based on the clinical outcome of the initial 15-patient pilot study that was conducted from 2011 to 2012 and published in an August 2013 issue of the New England Journal of Medicine.
The Foundation conducted a survey of 150 members of the focused ultrasound community on the state of the field prior to the October 2014 Symposium. Respondents were asked to identify which clinical indications were most likely to improve patients’ quality of life. Neurological and oncological indications are tied for the most votes, with brain tumors, essential tremor, and pancreatic cancer being rated as the top three individual indications. Similarly, respondents were asked to rank the top three bioeffects that are most likely to have long-term therapeutic value. Thermal ablation is ranked first, followed by drug delivery and neuromodulation.
Lian Zhang, MD, gastroenterologist with the Clinical Center for Tumor Therapy, Second Affiliated Hospital of Chongqing University of Medical Sciences, met with Alan Matsumoto, MD, Co-Director of the UVA Focused Ultrasound Center.Dr. Zhang is a leading clinician in the field, having been involved with focused ultrasound for more than 10 years. Chongqing Haifu’s focused ultrasound system is currently approved in China and Europe to treat uterine fibroids, breast cancer, liver cancer, kidney cancer, soft tissue tumors, and pain control for pancreatic cancer and bone metastases. The technology is quite established for uterine fibroids, with more than 100 Chongqing Haifu systems in OB/GYN offices around China.
Speakers at the European Congress of Radiology (ECR) Annual Meeting in Vienna, Austria, lauded the potential for Focused Ultrasound to be one of the most important treatment options on the horizon. MedicalPhysicsWeb.com reported on the conference, speaking with leaders in the focused ultrasound field about the key applications discussed.
Uterine fibroids remains the most widely approved application of focused ultrasound, with the potential to help countless women. Discussion centered on ideas to overcome the slow adoption rates to date.
The Focused Ultrasound Foundation has published its January 2014 Focused Ultrasound Global Perspective report, a comprehensive overview of the state of the technology, including facts and figures on approved indications, manufacturers, research centers, and treatment sites. This report will serve as a trusted resource for academia, government, industry, and investors, enabling them to monitor progress in the field and guide decision making.The report is now available on our website. An update will be produced every six months, identifying significant research and commercialization trends for the technology.
A major milestone in the evolution of the field of focused ultrasound has been achieved. The first treatment in a 20-patient pilot study assessing the feasibility, safety, and preliminary efficacy of MR-guided focused ultrasound for dyskinesia in Parkinson's disease was successfully performed in Korea. This groundbreaking study is being funded in partnership with the Michael J. Fox Foundation.
Focused ultrasound physics pioneer Professor Gail ter Haar, head of the Foundation’s Center of Excellence at the Institute of Cancer Research (ICR) in London, traveled with Foundation staff to Washington to deliver a presentation to the U.S. Food and Drug Administration (FDA) on her team’s work in quality assurance and standardization of high intensity focused ultrasound.
As reported in the current issue of Nature Neuroscience, scientists on Dr. William J. Tyler’s research team at Virginia Tech were interested in using focused ultrasound to noninvasively modify human brain function. They targeted sensory areas of the brain and were surprised by their findings: low-intensity focused ultrasound significantly improved function by decreasing impulses to the median nerve in the arm thereby enhancing the patients’ ability to discriminate between different kinds of stimulation. Secondly, they were impressed that the focused ultrasound could target smaller, more specific areas in the brain as compared to other neuromodulation technologies.
Focused ultrasound pioneer Dr. Wladyslaw Gedroyc has been named Clinical Editor-in-Chief of the Journal of Therapeutic Ultrasound(JTU), replacing start-up editor Dr. Arik Hananel.
A consultant radiologist, Dr. Gedroyc is recognized worldwide as a pioneer in the development of noninvasive patient treatments using MR-guided focused ultrasound. Much of Dr. Gedroyc's ground-breaking work involved the treatment of uterine fibroids, pancreatic tumors, and liver tumors. He is currently investigating a focused ultrasound application to alleviate the severe back pain associated with facet joint disease.
In October, Dr. Jeff Elias of the University of Virginia awed the TEDx Charlottesville audience of nearly 1,000 as he spoke about the transformational effects of focused ultrasound, including "before and after" video of his patients eating, writing, and reaching while living with essential tremor. See the talk that brought the crowd to its feet.
Focused ultrasound treatment for Parkinson's disease was featured as the cover story in the December issue of Practical Neurology.
The article consisted of a Q&A with Dr. Binit B. Shah, MD, Assistant Professor, Neurology, Parkinson's Disease and Movement Disorders Division at University of Virginia.
Additional research is being conducted around the world on breast cancer and breast fibroadenoma. For example, collaboration between Philips and Utrecht University Medical Center in the Netherlands is using an innovative system that has been designed specifically to treat breast tissue.
Focused ultrasound research presentations made an impressive showing at this year’s RSNA annual meeting. A remarkable 27 sessions featured research on focused ultrasound ablation and/or drug delivery to treat many different diseases, including breast cancer, bone metastases, pancreatic cancer, prostate cancer, melanoma, uterine fibroids, and osteoid osteoma.
Results of a study presented today at the annual meeting of the Radiological Society of North America (RSNA) suggest MR-guided focused ultrasound (MRgFUS) may offer a safe, noninvasive treatment option for breast cancer.
Radiology Today magazine featured a balanced article detailing the uses of focused ultrasound to treat a wide variety of disorders such as uterine fibroids, bone mets pain, essential tremor, Parkinson's disease, and more.
Experts who gathered at the June Brain Workshop were successful in identifying major opportunities and challenges for expanding the area in the brain that can be treated with focused ultrasound. Event details, including issues discussed and long-term projects, were reported in ourJuly newsletter.
The Annual Meeting of the American Society for Radiation Oncology (ASTRO) was held in Atlanta on September 22-25, 2013. This meeting is the largest assembly of radiation oncology physicians and researchers in the world. Focused ultrasound has a growing and important role in clinical research in radiation oncology, and highlights included:
1. J. E. Meyer from the Fox Chase Cancer Center presented their work on the pain palliation of bone metastases using focused ultrasound. Their retrospective analysis showed breast cancer metastases as having the best response rate (87%), which may impact future patient selection and treatment decisions.
The Foundation’s patient advocacy program, Fibroid Relief, has been garnering nationwide media coverage of a newly published survey that found that uterine fibroids cause significant fear and morbidity and can compromise workplace performance. It also found that women prefer treatment options that are not invasive and protect fertility (like focused ultrasound).
More than 200 clinicians and scientists from Europe and across the globe gathered in Rome this month for the Focused Ultrasound Therapy - 2nd European Symposium, which was supported by the Foundation.
“The symposium more than met our goals of sharing knowledge and stimulating new ideas,” said symposium co-chair Alessandro Napoli, MD, PhD, of Sapienza University of Rome. “The meeting helped to establish and consolidate relations, foster discussion of research approaches, and fuel advances in the field.”
The first essential tremor patient in the pivotal trial for the ExAblate Neuro Focused Ultrasound System has been treated at Stanford, and the study is starting at the University of Virginia, Swedish Neuroscience Institute in Seattle, and Yonsei University Medical Center in Seoul, Korea.
The trial is a multicenter, double-blinded, randomized study to evaluate the efficacy and safety of treatment using the ExAblate Neuro in medication-refractory essential tremor patients. The study builds upon promising pilot studies funded by the Focused Ultrasound Foundation that demonstrated the preliminary safety and effectiveness of FUS in treating target areas deep inside the brain. These studies were published in the New England Journal of Medicineand The Lancet Neurology.
The Foundation is now seeking applicants for the Richard Merkin Visiting Fellowship in Focused Ultrasound, created by Richard Merkin, MD, to foster collaboration between the Foundation and other institutions .
The Fellowship in Focused Ultrasound is open to any mid-career or senior scientist or clinician from industry or academia around the world to work with the technical and scientific team at the Focused Ultrasound Foundation in Charlottesville, Virginia for about 12 months. The position will foster collaboration between the Foundation, the Fellow's home institution, and other institutions and will be paid through an annualized stipend of $150,000.
The Focused Ultrasound Foundation and the Kinetics Foundation organized a workshop in September to discuss the state of the technology, current challenges, and future research directions for using focused ultrasound to reversibly open the blood-brain barrier to allow the delivery of drugs directly to the brain for treatment of cancer, Parkinson’s disease, Alzheimer’s disease, and other central nervous system disorders.
Feng Wu, MD, PhD, has been selected as Honorary President of the 4th International Symposium on Current and Future Applications of Focused Ultrasound to be held October 12-16, 2014 in Bethesda, Maryland.
Wu has been a steadfast champion of focused ultrasound for more than 25 years. To date, his teams in China have treated more than 50,000 tumor patients, the largest population of focused ultrasound-treated patients in the world. Now living in England, Wu is a Focused Ultrasound Consultant and Senior Clinical Scientist at Oxford University. He is a leading researcher in the field, having published more than 200 papers. In 2013, he was awarded the International Society for Therapeutic Ultrasound’s William and Francis Fry Award for his outstanding contributions to the field.
The first essential tremor patient in the pivotal trial for the ExAblate Neuro Focused Ultrasound System has been treated at Stanford, and the study is starting at the University of Virginia, Swedish Neuroscience Institute in Seattle, and Yonsei University Medical Center in Seoul, Korea.
The New England Journal of Medicine published the promising results of a pilot trial on the use of transcranial MR-guided focused ultrasound to treat patients with essential tremor (ET).
The results indicate that focused ultrasound can safely and effectively treat targeted areas deep in the brain. The study included 15 patients with essential tremor that could not be managed by medication who underwent a completely noninvasive unilateral thalamotomy using an investigational focused ultrasound device. The study was led by W. Jeffrey Elias, MD, (shown above with the ET patients) neurosurgeon at the University of Virginia, and funded by the Focused Ultrasound Foundation.
The Focused Ultrasound Foundation was recently awarded a $600,000 grant by The Michael J Fox Foundation for Parkinson’s Research to help fund a pilot study of focused ultrasound for the treatment of dyskinesia in Parkinson’s disease. The study will investigate the feasibility, safety and preliminary effectiveness of focused ultrasound as a non-invasive method to destroy a small volume of targeted tissue in the brain to improve motor symptoms and reduce the involuntary movements (dyskinesia) faced by Parkinson’s patients.
A high-dose of ultrasound targeted to painful bone metastases appears to quickly bring patients relief, and with largely tolerable side effects, according to new research presented by Fox Chase Cancer Center scientists at the 49th Annual Meeting of the American Society of Clinical Oncology on Monday, June 3.
Ultrasound Symposium Agenda - Tuesday, August 6
Session 1: Clinical Delivery and Advanced Novel Technologies/Strategies
Moderators: Chang Ming Charlie Ma, Fox Chase Cancer Center and Cyril Lafon, INSERM, University of Lyon
8:00 AM Clinical Delivery and Advanced Novel Technologies/Strategies
Presenters: N. Sanghvi, A. Hananel, M. Hurwitz, C. Moonen
Researchers from the Bonn University Hospital in Germany have filed a patent application for a focused ultrasound method that reduces impairment of cardiac function after an acute heart attack. In the method, microbubbles are injected into the bloodstream following a heart attack. When the bubbles reach the heart, stimulation with focused ultrasound causes them to oscillate and ameliorate the muscle damage that normally occurs after cardiac arrest.
From the level of traffic at its booth to the “Best Poster” honors bestowed on two abstracts featuring its HIFU treatment for prostate cancer, focused ultrasound device maker EDAP TMS reported a “heightened level of interest and enthusiasm” among physicians and others attending the 2013 meeting of the American Urological Association (AUA) in May. Now in use in 29 countries, EDAP’s prostate cancer treatment device – the Ablatherm – is awaiting regulatory approval in the U.S.
Patients with localized prostate cancer are receiving treatment in a new clinical study assessing the safety of a transurethral ultrasound ablation system developed by Toronto-based Profound Medical Inc. The system, which uses a specially designed wand to deliver thermal ablative therapy, operates under MR guidance. It works on a variety of MRI platforms, can be moved from scanner to scanner and treats the whole prostate gland in one session.
First patient trial at Swedish Medical Center will be for essential tremor
One of the most prestigious neuroscience centers in the world is gearing up to become a major clinical force in MR-guided focused ultrasound brain research. Swedish Neuroscience Institute (SNI) at the Cherry Hill campus of Swedish Medical Center in Seattle, Washington, USA will soon treat patients with essential tremor as part of an upcoming Phase III multicenter randomized trial and is considering studies for epilepsy, Parkinsonian tremor, metastatic tumors and intracerebral hemorrhage.
The Gray Sheet, a cornerstone medical device publication for the healthcare industry, touts promising data on FUS for essential tremor and recognizes the Foundation's unique model in supporting research.
The encouraging results of the Focused Ultrasound Foundation-funded essential tremor Phase I pilot clinical trial at the University of Virginia have led to planning for the next data-gathering step required for regulatory approval: a global, multi-site pivotal Phase III study to evaluate the safety and efficacy of transcranial MR-guided focused ultrasound in treating essential tremor. Device maker InSightec, Ltd., which is sponsoring the study, has obtained U.S. Food and Drug Administration approval for a double-arm protocol and expects as many as eight sites and 72 patients to participate.
AANS PRESS RELEASE Embargoed until April 29, 2013, 2:30 p.m. CDTContact:John A. IwanskiDirector of Member and Public Outreach(847) 378-0517 |
Subjects of Phase I Study of Transcranial MR-guided Focused Ultrasound Thalamotomy See Reduced Tremor,Improved Quality of Life
NEW ORLEANS (April 29, 2013) — Research findings offered today during the 81st American Association ofNeurological Surgeons (AANS) Annual Scientific Meeting show that the use of transcranial MR-guided focused ultrasoundfor producing a thalamotomy can have significant positive effects on subjects suffering from essential tremor.
Many of the 15 patients who participated in the Focused Ultrasound Foundation-funded pilot essential tremor study at the University of Virginia have stepped forward to share their story with the news media. By doing so, they have added a new dimension to the role patient participants play in advancing a promising new medical technology. Their courage and their stories have touched people around the world and spurred interest in using noninvasive sound waves instead of scalpels to treat movement disorders.
When James Drake, MD submitted his proposal for the “Chase an Idea” grant, pediatric focused ultrasound was the idea he wanted to chase. Drake, the chief of neurosurgery at the Hospital for Sick Children (SickKids) in Toronto, Canada, understood the potential of focused ultrasound and was eager to explore its use in children. Receipt of that grant, from the Centre for Brain and Behavior at SickKids, provided the means to establish the Center for Image Guided Innovation and Therapeutic Intervention (CIGITI) with Drake at the helm.
The growing field of therapeutic ultrasound welcomes its first open access journal
Open access publisher BioMed Central is proud to announce the launch of Journal of Therapeutic Ultrasound in partnership with the Focused Ultrasound Foundation and the International Society for Therapeutic Ultrasound.
Therapeutic ultrasound is a fast growing field and all parties involved believe that having a dedicated open access journal in this area can only speed up the development and eventual adoption of this important clinical tool by the wider medical community.
Focused ultrasound has the potential to be an alternative or complement for radiation therapy, the means to dissolve blood clots, and a way to deliver drugs in extremely high concentrations to a precise point in the body. It has the potential to treat a variety of serious medical disorders, including cancer, uterine fibroids, essential tremor, Parkinson’s disease, epilepsy, and neuropathic pain.
“Focused ultrasound technology has enormous potential to improve the quality of lives for millions around the world,” noted Neal F. Kassell, M.D., Chairman and Founder of the Focused Ultrasound Foundation. “The research reported in the Journal of Therapeutic Ultrasound will be central to advancing the field and will help accelerate the progress of focused ultrasound towards clinical adoption.”
Journal of Therapeutic Ultrasound encompasses all aspects of therapeutic ultrasound, namely, the stimulus, inhibition, or modification of tissue function or structure via insonification. Led by Editors-in-Chief Arik Hananel, Focused Ultrasound Foundation, USA and Robert Muratore, Quantum Now LLC, USA, with an international editorial board consisting of the best in the field of focused ultrasound, this open access, peer-reviewed, online journal focuses mainly on translational and clinical research.
Deborah Kahn, BioMed Central’s Publishing Director said, "We’re very pleased to welcome the Focused Ultrasound Foundation and the International Society for Therapeutic Ultrasound as new publishing partners to BioMed Central, and we share their excitement in launching the Journal of Therapeutic Ultrasound within our growing list of society journals."
The launch edition includes two research articles. One looks at the impact of vaporized nanoemulsions on ultrasound-mediated ablation. If these results can be replicated in the clinic, microbubbles could improve the efficiency of high intensity ultrasound treatment of solid tumors. An editorial on ‘The Journal of Therapeutic Ultrasound - broadening knowledge in a rapidly growing field’ by Editors-in-Chief Arik Hananel and Robert Muratore, is also featured.
All Article-Processing Charges (APC) for the journal are currently covered by the Focused Ultrasound Foundation.
Media ContactRebecca FairbairnPublic Relations Manager, BioMed CentralTel: +44 (0) 20 3192 2433Mob: +44 (0) 7825 257423Email:
Patient recruitment is underway at St. Peter’s Hospital in Melbourne, Victoria for a clinical trial assessing the safety of a focused ultrasound system in treating patients with drug-resistant hypertension. Manufactured by privately-held, US-based Kona Medical, the system is designed to noninvasively ablate renal nerves, which play a significant role in determining blood pressure. Entitled, “A Feasibility Study: A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension,” the study is expected to treat as many as 20 patients between now and September 2013 and follow them for 24 weeks. Principal Investigator is Robert Whitbourn, MD. Further information can be obtained by emailing Catherine Peeler at
EDAP TMS SA reports that patients with prostate cancer are being successfully treated at the St-Augustin Urology Clinic in Bordeaux, France utilizing the company’s Ablatherm High Intensity Focused Ultrasound system. Dr. Thierry Piechaud, partner and urology surgeon at the clinic, noted, "We are very enthusiastic about adding the Ablatherm-HIFU device to our therapeutic arsenal. We believe HIFU has developed a clear lead among other current technologies as a new approach and a modern concept of non-invasive treatment for early stage prostate cancer which preserves patient quality of life." EDAP reports that there are 278 Ablatherm installations worldwide.
Recent comments by executives of EDAP TMS and US HIFU indicate that interest in focused ultrasound treatment for prostate cancer is increasing among members of the American Urological Association. Marc Oczachowski, Chief Executive Officer of EDAP TMS, said that the company “experienced record attendance and exceptional enthusiasm from U.S. urologists” at its exhibit booth at the AUA meeting, which was held May 19–23, 2012 in Atlanta. He noted that “awareness levels are building” as the company prepares for to submit its Ablatherm-HIFU filing to the US FDA later this year.
Mike Klein, US HIFU Chief Executive Officer said, "We have an unprecedented number of meetings scheduled at AUA.” He added that the company, which is conducting US clinical trials of its Sonoblate system, was “actively seeking insight from urologists to guide the development of HIFU technologies to further enhance the safety and efficacy and identify areas of interest to focus studies and clinical trials for a wide range of applications." READ PRESS RELEASE
Watching patients suffer from metastatic prostate cancer motivatedSarfraz Ahmad, MBBS, PhD, MRCSI, MRCSEd to pursue a career in urological surgery. His belief in focused ultrasound’s ability to help those patients propelled him to apply for a two-year Foundation fellowship, which he received in August 2011.
In his fellowship application, Ahmad wrote: “I truly believe that treatment based on the principles of ultrasound energy has a great future. This is not only a minimally invasive intervention but also can be repeated without any significant side effects. This is in contrast to current treatment options such as radiotherapy and use of opoids as pain killers. I am committed to academic urology with a focus on MRgHIFU treatment in localised and metastatic prostate cancer treatment.”
Since installing an ExAblate 2100 system in May 2010, Sapienza University of Rome has emerged as a driving force for the European focused ultrasound community. Within six months of opening, its clinical team had treated 15 patients with uterine fibroids and was involved in clinical trials for prostate, breast and pancreatic cancer. In fact, the center was the first in the world to use MR-guided focused ultrasound to provide pain palliation for patients with primary pancreatic cancer.
The special symposium will provide day-long programs dedicated to education, therapy and diagnoses. Scheduled for August 2, the session on therapy is being organized by Christian Diederich, PhD, Director of the Thermal Therapy Research Group at the University of California San Francisco. His collaborator is Stanley Benedict, PhD, Associate Professor and Director of Radiological Physics at the University of Virginia.
Clinician interview: Matthias Matzko, MD, Amper Kliniken AG, Dachau, Germany
Matthias Matzko, MD has emerged as a leading European advocate for MR-guided focused ultrasound. In his native Germany, he has also played a key role in eliminating one of the most challenging barriers to widespread adoption of the promising medical technology: reimbursement.
Head of Interventional and Diagnostic Radiology at the 450-bed Amper Kliniken AG in Dachau, Matzko learned about focused ultrasound in 2008 from a colleague. He admits to becoming “kind of infected” with enthusiasm for the technology after visiting Wladyslaw Gedroyc, MD at St. Mary’s Hospital in London.
Matzko immediately recognized the potential of focused ultrasound and wanted to offer it at his hospital’s Myomzentrum, a center for the treatment of uterine myoma (fibroids), which had opened in June 2008. The center was already performing uterine artery embolization, myomectomy and hysterectomy.
“When I came back from London, I was very excited about the technology, and I was thinking about how to implement this in our environment,” he recalls. “Talking with the hospital administration, they were unsure about investing in the risk of a new method.”
De-risking equipment acquisition
So strong was his conviction, the business-savvy Matzko offered to rent a focused ultrasound system through an imaging company he heads and have it set up in the hospital. “I took the risk off the hospital administration,” he says. Arrangements were made through GE Financial to lease an ExAblate System from InSightec, Ltd.
At first, Matzko and his team performed focused ultrasound procedures only on Wednesdays and Saturdays, during time slots when the Myomzentrum’s MRI was made available to them. They performed five to ten treatments a month. As more patients learned about the availability and benefits of focused ultrasound, the center’s monthly treatment volume increased to 10-12 patients. “Our machine was fully booked in advance for about a four-month period of time,” Matzko explains.
Careful patient selection aids reimbursement
From the start, Matzko and his colleagues were convinced that careful patient selection was essential to achieving good results with focused ultrasound. Only a third of their uterine fibroid patients met the treatment criteria. “When you want to have reimbursement for such a new method, you have to produce good results, and that’s why you have to select patients very carefully,” he says.
With good results and patient satisfaction documented, Matzko and colleagues applied for reimbursement from Techniker Krankenkasse (TK), one of the largest insurance companies in Germany. Company representatives visited Amper Kliniken and focused ultrasound treatment sites in Berlin and Bochum.
Matzko says two factors were of greatest interest to the insurance company: 1) that only patients suited for focused ultrasound were treated with it; and 2) the Myomzentrum’s interdisciplinary team, which includes a gynecologist who provides both treatment and information to patients.
Although pleased with both the clinic’s results and services, the insurance company raised a red flag. The capacity to treat only three patients a week seemed too limited to qualify for reimbursement from a nationwide insurer.
Rather than a barrier, this objection became the basis of collaboration between the clinic, the insurance company and – ultimately – Amper Kliniken’s administration. Together, they planned the expansion of the existing focused ultrasound center. By this point, Matzko explains, “The hospital administration was convinced about the method of focused ultrasound and convinced about the business model.”
The expanded center opened in March 2010 with a fully dedicated MRI and ExAblate 2000. By then, the two largest German medical insurers were covering MR-guided focused ultrasound treatments. With all the pieces in place, the center’s monthly treatment volume quickly doubled.
The Dachau clinic continues to be on the leading edge of focused ultrasound technology. In November 2010, it became one of the first sites in the world to install the ExAblate One, the second generation system developed by GE Healthcare and InSightec. In the future, Matzko plans to expand treatment offerings to include new applications of the technology.
Marketing is another key to success
Matzko acknowledges that marketing was initially a challenge for the focused ultrasound center. “We started in a typical radiological manner,” he says. “We did marketing to referring physicians, and we informed all of our gynecologist colleagues in the south of Germany, in Switzerland, in Austria about our new center. The result was very poor.”
Recognizing that a strategy switch was in order, the center began marketing directly to patients via a new website and the use of Google ads. Increased patient requests for information led to the creation of a 24-hour hotline staffed by two patient managers knowledgeable about uterine fibroid treatment options. “Our aim is to figure out the ideal method to treat the personal situation of the patient,” Matzko explains.
In addition to Germany, Austria and Switzerland, the Dachau clinic is attracting patients throughout Eastern Europe and elsewhere. “They come from Poland, from Russia, from Bulgaria and even we had one patient coming in from Dubai,” Matzko notes. “We now have, in a small hospital like ours, an international customership.”
The Focused Ultrasound Surgery Foundation has awarded a $232,808 research award to Wladyslaw M. Gedroyc, M.D. of St. Mary’s Hospital in London for a two-year randomized clinical trial comparing MR-guided focused ultrasound with radiofrequency ablation in the treatment of back pain caused by facet joint disease.
The clinical trial marks the next step in Gedroyc’s pioneering efforts to develop a noninvasive treatment for facet joint disease that provides more complete and longer lasting pain relief than current therapies. He and his team at St. Mary’s Hospital have already conducted a non-randomized pilot clinical trial in which MR-guided focused ultrasound was used to treat 17 patients suffering from extreme back pain caused by facet joint osteoarthritis. Post-treatment assessments show the technology is safe and effective. Click hereto read full story and watch video interview.
Clinical trials using MR-guided focused ultrasound to treat uterine fibroids and pain from cancer that has metastasized to bones are enrolling patients at the University of Virginia Health System. Details of those studies are reported in the latest issue of the UVA edition of Physician’s Practice Magazine.Click below to view the full report.
UVA Physicians Practice Magazine Article
Page 1 of 2