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.
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Parkinson’s Disease (PD) is a neurodegenerative brain disease that is progressively debilitating and leads to motor dysfunction and cognitive decline. PD affects more than 10 million people worldwide and nearly 1 million in the US. Healthcare costs in the US alone related to PD are estimated at $52 billion per year.
The first patient has been treated in a new phase I/II clinical trialfor patients with recurrent glioblastoma (GBM). Researchers at Northwestern University in Chicago will recruit up to 39 patients to have CarThera’s SonoCloud-9 implanted after surgical removal of the tumor, as it will be used to temporarily open the blood-brain barrier (BBB) prior to the administration of chemotherapy.
The Foundation receives many inquiries about the various applications of focused ultrasound. We want to share some of the most commonly asked questions to help our community quickly locate the information they need.
Does the Foundation conduct patient consultations or treat patients?Our main function is to identify and fund research projects in order to make focused ultrasound therapies more readily available to treat patients. We do not conduct patient consultations, nor do we treat patients. We are sometimes able to help connect people with physicians who can either consult with them and their families or provide focused ultrasound treatments.
Is the Foundation operated by the government or owned by manufacturers?No, the Foundation is an independent, tax-exempt organization that is entirely supported by donations with the goal of helping advance focused ultrasound to be available to treat patients in the shortest time possible. We are a small organization, and we do our best to steward our resources to advance the field of focused ultrasound. Read more about the Foundation.
The opioid epidemic is a national crisis. Every day, an estimated 130 people die in the United States from an opiate related overdose. Many of these deaths can be attributed to an initial or current misuse of prescription opioids, often prescribed to treat acute and chronic pain. The US Centers for Disease Control and Prevention (CDC) estimates that the annual economic burden of prescription opioid misuse in the United States alone is $78.5 billion, which includes the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. About 80 percent of people who use heroin have misused a prescription opiate first. These types of staggering statistics go on, but the point is that the opioid epidemic is a real problem requiring realistic, effective, and timely solutions.
A Multi-faceted ApproachMany different areas need improvement when considering potential solutions to the opioid crisis, and it will likely be advancement in all of them that results in a real progress. Those who already suffer from an opioid misuse disorder need improved access to evidence-based treatment. It is imperative to advance research in overdose therapy, medication-assisted therapy, and opiate abuse risk reduction. Most relevant to the field of focused ultrasound is the establishment and promotion of alternatives to opiate-based medications for the treatment of pain. Another area that has the potential to use focused ultrasound is in the identification and development of new therapies to aid in abstinence from opiates.
A recent Centers for Medicare and Medicaid Services (CMS) announcement declared a positive local coverage decision (LCD) for patients undergoing unilateral focused ultrasound thalamotomy for tremor-dominant Parkinson’s disease. Palmetto GBA, a Medicare Administrative Contractor (MAC) covering many states in the Southeast, will now cover the procedure for patients treated on or after February 10.
Bob Dienst has always been a man of many talents. That is until essential tremor sidelined him from the activities he enjoyed.
After leaving the Army as a helicopter pilot, Bob began a career in law enforcement in 1972 in New Jersey. He first noticed symptoms of essential tremor a year later when his marksmanship scores declined.
A new clinical trial using focused ultrasound to address Alzheimer’s disease has begun at Columbia University in New York. Researchers are investigating the safety and feasibility of using a novel focused ultrasound device in combination with microbubbles to temporarily open the blood-brain barrier (BBB) in patients with Alzheimer’s disease.
This 20-patient clinical trial is using Insightec’s Exablate Neuro device to temporarily and reversibly open the blood-brain barrier (BBB) in glioblastoma (GBM) patients undergoing standard chemotherapy treatment.
After more than 50 years as a NASA safety engineer, Victor Murray has learned to trust science. “My career requires me to find the answers to problems. I was part of the Apollo 13 fix. When something is wrong, there has to be a fix for it.”
Neuropathic pain is a fairly common condition, affecting an estimated 7-10% of the population.
Meet Tammy. Air travel is not high on most people’s list of favorite activities, but for Tammy, it meant more than just a fear of flying. Debilitating neuropathic pain in her hip made it impossible to sit still for any length of time.
“I couldn’t sit through a flight without constantly fidgeting due to the pain radiating throughout my lower back and legs,” she explains. “I absolutely dreaded flying. I couldn’t even watch an entire movie without pain. It truly affected my whole life.”
Parkinson’s disease is an increasingly common nervous system disorder, with a growing list of high profile patients who are helping to lead the fight for better treatment options and creating hope for a cure.Focused ultrasound is an early-stage, noninvasive therapy that is now in clinical trials to treat the motor symptoms of Parkinson’s. The Focused Ultrasound Foundation has funded and been involved with many clinical trials over the past 12 years, including a successful effort to find a treatment for essential tremor (ET), which is a movement disorder with symptoms similar to Parkinson’s disease. Our experience with ET has provided a base of knowledge that may be helpful as patients consider participating in a new clinical trial for Parkinson’s disease.
For most people, gaining 25 pounds over the course of a year is not cause to celebrate. But Ron Nickelson sees the change as tangible evidence of how far he has come.
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 Cancer Research Institute kicked off their 2017 Immunotherapy Patient Summit Series with the first event in San Francisco on July 8.
The field of focused ultrasound achieved a critical milestone in July 2016 with the approval of the first ever brain indication for the technology in the US. The Food and Drug Administration (FDA) approved Insightec’s Exablate Neuro focused ultrasound system for the non-invasive treatment of essential tremor (ET), the most common movement disorder.
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.
Beginning at age 25, Steve noticed he was losing control of his grip. “I was working a mobile repair service that installed new airbags and interior components in vehicles that had been in a wreck,” he explains. “I started to lose my ability to hold tools, turn screwdrivers, and use wrenches effectively.” After visiting several local neurologists, Steve was referred to Dr. Shannon at Rush University in Chicago and was diagnosed with young onset Parkinson’s disease.
For most of her life, Michigan resident Kristin “Sunny” Berry was able to manage her tremors enough to continue her beloved artistic hobbies.
As focused ultrasound becomes more widespread, many more patients’ lives are being transformed – especially those with movement disorders like essential tremor and Parkinson’s.Watch three patients share their stories about how the treatment changed their outlook through the news media.
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.
Just a week after undergoing FUS for his tremor at the University of Maryland, Peter Muller visited the Symposium to meet some of the leading researchers in the field and the innovators at Insightec that developed the technology.
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.
Al Jazeera's program "The Cure" follows Sunny, an essential tremor patient at Ohio State University as she undergoes focused ultrasound to ease her tremors.
The following is a press release from InSightec announcing essential tremor approval in Canada. View the release on Insightec's website >
Reed Yadon was living a busy life in Kentucky as a television meteorologist and helicopter pilot when he says his world suddenly changed. After a routine annual physical revealed his prostate-specific antigen (PSA) level had increased, a urologist confirmed one of his worst fears: he had prostate cancer.
In the wake of FDA approval, HIFU Prostate Services (HPS) has been created to facilitate rapid adoption of focused ultrasound treatment for the prostate. We interviewed John Linn, Chief Executive Officer of HPS, to better understand the company’s plans for successful commercialization of FUS technology in the US, patient support and recruitment, and physician support and training. HPS is the first company to establish centers in the US offering SonaCare’s Sonablate HIFU technology.
Prostate ablation is the leading application of focused ultrasound, having been used to treat benign prostatic hyperplasia (BPH), partial gland cancer, localized whole-gland cancer, and recurrent cancer. While HIFU may be helpful, active surveillance may be the most appropriate approach for early disease. In cases where the physician recommends treatment or the patient prefers treatment, focused ultrasound may be a good alternative.
For Kimberly Spletter, bike rides had always been a source of relaxation, until she was diagnosed with Parkinson’s disease. She could no longer safely balance on her bike and had to turn to riding a stationary bike instead, as the uncontrollable movements associated with the illness even compromised her ability to walk.
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.
Last May, members of the US House of Representatives announced the 21st Century Cures initiative to keep America at the forefront of medical innovation.
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.
In a recent Fox News interview, Carol Alt, host of A Healthy You, sat down with Lisa Davis, host of It’s Your Health Network, to talk about 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.
Patients from Across the Country Participating in Essential Tremor Trial
The University of Maryland’s pioneering Neuroscience Center in Baltimore is poised to become a leading hub for focused ultrasound research. They recently began treating patients in the pivotal trial to treat essential tremor using InSightec’s Exablate Neuro system.
The following release was issued by The Hospital for Sick Children (SickKids) on August 6, 2014. View the release in their press room.
TORONTO – A patient at The Hospital for Sick Children (SickKids) is the first child in North America to have undergone a specialized procedure that uses ultrasound and magnetic resonance imaging (MRI) to destroy a tumour in his leg without piercing the skin. Doctors used an MRI to guide high-intensity ultrasound waves to destroy a benign bone tumour called osteoid osteoma. The lesion had caused 16-year-old Jack Campanile excruciating pain for a year prior to the July 17 procedure. By the time he went to bed that night, the athletic teen experienced complete pain relief.
A new InSightec study to determine feasibility and safety of using the ExAblate System to treat localized, low-risk prostate cancer has begun in California. Jeffrey Wong, MD, Professor and Chair of the Department of Radiation Oncology and Associate Director of the Prostate Cancer program at City of Hope in Duarte, California is the principle investigator at City of Hope. The study will begin enrolling at the Mayo Clinic in Rochester, Minnesota, and other locations. City of Hope is the first U.S. site to treat a patient enrolled in this study.
Patients who are interested in this study, should contact Maria Brooks at City of Hope (626) 256-4673 ext 64402,
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.
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.
The British Broadcasting Corporation (BBC) visited the University of Virginia earlier this year to document a patient being treated as part of the ongoing Parkinsonian Tremor clinical trial, led by UVA Neurosurgeon W. Jeffrey Elias, MD and funded by the Focused Ultrasound Foundation.
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).
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 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.
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.
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.
One of Billy R. Williams’ most cherished possessions is a photo album chronicling the day he made medical history by becoming the first person in the world to undergo focused ultrasound treatment for essential tremor. “I always wanted to be Number 1 at something, and this was it,” he says of his participation in the Focused Ultrasound Foundation-funded pilot essential tremor study at the University of Virginia. His treatment experience, which has been reported in print and video interviews, has inspired thousands and offered new hope to others in the essential tremor community.
The 15 patients who enrolled in the Focused Ultrasound Foundation-funded essential tremor (ET) study at the University of Virginia are true medical pioneers. Prior to their focused ultrasound treatment, most had lived with ET for decades. All had become severely disabled by it. Each believed they had run out of viable treatment options until learning about the promise and possibilities of focused ultrasound. Bravely stepping forward to join the study, each identified three outcomes they wanted to experience.
European Radiology has e-published ahead of print the results of a Foundation-funded pilot clinical trial in which Evan M. Weeks, MD and his colleagues at St. Mary’s Hospital in London used focused ultrasound to successfully treat 18 patients with low back pain caused by facet joint osteoarthritis.
During a June 2 golf tournament, 91-year-old Doris McArdle stepped up to the tee and took a full swing, typical of her approach to life. Nineteen months ago, McArdle was struggling with acute pain and discomfort caused by a large benign pancreatic tumor. Thanks to a series of fortuitous events and a vast amount of personal courage, she travelled to St. Mary’s Hospital in London where she received focused ultrasound treatment on a compassionate care basis. READ STORY
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
Billy R. Williams is proud to be the first patient in the world to receive focused ultrasound treatment for essential tremor. A year after his procedure, which marked the beginning of the ground-breaking pilot clinical trial at the University of Virginia, he reports being "very, very happy" with treatment results. In a video interview, Williams and UVA neurological physical therapist Diane Huss, PhD, say that some tremor has returned but is being managed by a small and well-tolerated drug dose.
Known as a luminary in medical imaging, Dennis L. Parker, PhD is currently devoting much of his time to focused ultrasound. Parker, a professor of Radiology at the University of Utah and Director of the Utah Center for Advanced Imaging Research (UCAIR), is co-leading the development of a high intensity focused ultrasound (HIFU) system for breast tumors.
The project’s origins trace back to 2003 when Utah purchased its first MRI scanner from Siemens. “Because the Siemens MRI scanner was very open as far as its software architecture, our students were able to very, very quickly establish a closed feedback loop feeding images out of the scanner into the ultrasound controlling computer that we had at the time,” Parker recalls. This led to the development of a closed-loop MRI guided focused ultrasound system.
“When Siemens came to visit in 2004, they actually decided to pick up that project and provided some funding,” he notes. At the time, Image Guided Therapy (IGT), a French medical device maker, had just designed a phased-array focused ultrasound transducer.
“Siemens purchased that device and placed it in Utah as IGT’s first large animal focused ultrasound system,” Parker adds. “Ever since that time, we’ve been working with them.”
By 2006, Parker and his collaborators decided that the best candidate site for their system would be the breast, and they applied for funding from the National Institutes of Health to develop a prototype. “It was an academic/industrial partnership,” he says. “We were very lucky. We were funded on the first submittal, which is very rare, but we were delighted.”
His collaborators on the project represent numerous disciplines and several departments at the University of Utah. In addition to Parker, the team includes Robert B. Roemer, PhD from Mechanical Engineering; Douglas Christensen, PhD from Bioengineering; Allison Payne, PhD, Rock Hadley, PhD, Emilee Minalga, PhD, Robb Merrill, PhD and Nick Todd, PhD from UCAIR; Leigh Neumayer, MD from Surgery/Oncology; and many students.
New breast system has unique features
Utah’s system, says Parker, “has a lot of capabilities not found in other breast HIFU systems.” Unique features include the placement of the focused ultrasound transducer. Mounted on flexible bellows made of PlastiDip (an idustrial grade fabrication material), the transducer can be moved into and out of the treatment cylinder as needed. Also unique is that the transducer shoots laterally. The system has a small water box in which the breast is suspended. That box has an array of radio frequency coils around it. According to Parker, this provides “image quality from the MR side [that] is actually very, very good.”
The system’s other major components are an MR-compatible ultrasound generator made by IGT and a Siemens MRI scanner.
Now in prototype form, the system has been tested on phantoms and samples. “From the standpoint of something that could ultimately be used to treat breast cancer, I think this is an excellent potential device,” Parker says. “The advantage of HIFU for breast cancer is that it’s totally noninvasive. It has the opportunity eventually to totally eradicate the disease without any surgical intervention at all.”
A patent application has been filed for the system and further improvements are planned. “There are many problems that still need to be solved,” he notes. “Measuring temperature in fat, which is a major component of breast tissue, has not been solved yet by others. We’ve got a good technique that is starting to work and we’re optimistic that with all these little pieces it’ll be a good system.”
The team, says Parker, will seek funding to develop modifications that improve image quality and enable the system to treat more aspects of breast disease. “Our new design should be able to treat much more of the disease, including many metastatic lesions,” he notes.
Written by Ellen C., McKenna
While many cases of ET are mild, according to Neal Kassell, MD, chairman of the Focused Ultrasound Surgery Foundation, some patients suffer severely ... http://www.agingwellmag.com/news/ex_040312.shtml
In a recent email, Matthias Matzko, MD, head of Interventional and Diagnostic Radiology at Amper Kliniken AG in Dachau, Germany wrote, “We are proud to announce that we passed the 500th treatment in total for uterine fibroid ablation with MRgFUS last week. With the new ExAblate ONE System, we already have the experience of more than 230 treatments with a significant higher rate of success with this new technology in comparison to the old system ExAblate 2000.”
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