Disbursements from the Focused Ultrasound Foundation's Research Awards Program passed the $3 million mark this month with the selection of two new funding recipients. (See chart for details.)
Since its launch in September 2007, the Research Awards program has become a major and increasingly competitive source of financial support for pioneering focused ultrasound studies. To date, the program has provided nearly $3.2 million in funding to 31 projects exploring applications ranging from uterine fibroids, pelvic disease and knee osteoarthritis to cancers of the brain, breast, head, liver, neck and prostate.
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Craig H. Meyer, PhD has received a $100,000 Research Award from the Focused Ultrasound Foundation to develop a new real-time method for performing three-dimensional MR temperature mapping, a technique that could have a major impact on the safety, efficacy and procedural efficiency of focused ultrasound treatments.
Foundation-funded pilot studies in U.S. and Canada laid groundwork for new trial
The trial will be a double-blinded, and patients will randomly be assigned to either a treatment or control (sham treatment) group. The study’s follow-up period will be one year.InSightec Ltd. announced on February 19, 2013 that the U.S. food and Drug Administration has approved the protocol for its pivotal Phase III clinical trial for treatment of essential tremor using the company’s ExAblate Neuro system. Intended to provide the safety and efficacy data needed for FDA pre-marketing approval, the multi-center study is expected to begin in mid-2013 and will be led by University of Virginia neurosurgeon W. Jeffrey Elias, MD.
InSightec’s ExAblate Neuro receives the go-ahead from FDA to begin its pivotal Phase III trial for Essential Tremor
February 19, 2013 (Tirat Carmel, Israel). InSightec Ltd announced that it has received FDA approval to begin its pivotal Phase III clinical trial for treatment of essential tremor using ExAblate® Neuro. This trial is intended to provide the safety and effectiveness data about the use of ExAblate® Neuro in order to support FDA pre-marketing approval.
“Tremors and their treatment” was the topic of a Grand Rounds talk given on January 9, 2013 at the National Institutes of Health Clinical Center by University of Virginia neurosurgeon, W. Jeffrey Elias, MD. During the hour-long presentation, Elias described the differences between Parkinson's tremor and essential tremor and provided an overview of surgical treatments for those conditions. He brought along two patients, one of whom has Parkinsonian tremor and was treated with Deep Brain Stimulation (DBS).
The study, which is expected to enroll 224 women between 18 and 50 years old, represents the next leg of Philips’ journey toward FDA approval of its Sonalleve MR-HIFU system as a treatment for uterine fibroids, benign tumors that affect 20-50 percent of pre-menopausal women over 30 years old.Three sites are now recruiting uterine fibroid patients for a Phase II/III study assessing the safety and efficacy of the Sonalleve MR-guided focused ultrasound system manufactured by Philips Healthcare. The study – Philips Pivotal Clinical Trial for MRI-HIFU of Uterine Fibroids– is now recruiting patients at St. Luke’s Episcopal Hospital in Houston, Texas, USA, Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada and Samsung Medical Center in Seoul, Korea. Patient recruitment is pending at two other U.S. study sites, Johns Hopkins Hospital in Baltimore, Maryland and the University of Chicago in Chicago, Illinois.
The pipeline for clinical studies using focused ultrasound to treat brain conditions is more robust than ever. Neal Kassell, MD, chairman of the Focused Ultrasound Foundation says this is key to his positive 2013 outlook for the field of focused ultrasound.
Asserting that the brain is the most complex and most difficult organ to treat, he says, “Developing safe and effective treatments for brain conditions is the best way to validate focused ultrasound technology and to accelerate its application throughout the body. It doesn’t take an enormous leap of faith to understand that if you can treat something deep in the brain with extreme precision and accuracy—safely and effectively—in a patient who’s wide awake, with no anesthesia, that you can use focused ultrasound in other areas of the body.”
The Therapeutic Ultrasound Winter School is scheduled for March 17-22, 2013 in Des Houches, France
Topics will range from an introduction to the physics and biophysics necessary to understand therapeutic ultrasound techniques to their clinical application. The school will provide a current overview of the field as a contextual background for the work of participants and encourage discussion and shared consideration of different approaches to understanding ultrasound therapy.
Session organizers are:
Gail ter Haar, The Institute of Cancer Research, London, UK
Vera Khokhlova, Moscow State University, Moscow, Russia
Mathieu Pernot, Institut Langevin, Paris, France
Jean-François Aubry, ESPCI, Paris, France
The abstract submission deadline for the Society of Thermal Medicine 30th Annual Meeting (STM 2013– Focusing on Heat) is December 5.
The meeting will be held April 17-21 in Aruba.
STM 2013 will cover all areas of thermal medicine and place added emphasis on focused ultrasound- based thermal therapies. Keynote speakers include Kullervo Hynynen, PhD (University of Toronto), Bradford Wood, MD (NIH) and Amato Giaccia, MD (Stanford University).
On October 30, the AANS Neurosurgeon reported, "The Focused Ultrasound Foundation has announced a new clinical trial investigating the use of focused ultrasound technology to treat patients with tremor-dominant Parkinson’s disease. Funded in part by the Foundation, the study has treated its first two patients at the University of Virginia to evaluate the noninvasive technology’s safety and effectiveness in alleviating medication-resistant Parkinsonian tremors."
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Virginia Senator Mark Warner gave the keynote address for the Diane and David Heller Lecture at the 2012 Focused Ultrasound Symposium on October 16th in Bethesda, MD.
Focused ultrasound researchers are encouraged to submit abstracts to the 11th International Stereotactic Radiosurgery Society Congress which is scheduled for June 16-20, 2013 in Toronto, Canada. Abstract guidelines and submission 11th International Stereotactic Radiosurgery Society Congress
A report published on Oct 17, 2012 on medicalphysics.com spotlighted four presentations given at the 3rd International Symposium on Focused Ultrasound that was hosted from October 14-17, 2012 by the Focused Ultrasound Foundation.
Elisa Konofagou, PhD envisions a day when effective treatments and cures are available for neurodegenerative diseases such as Alzheimer's, Parkinson's, multiple sclerosis and amythrophic lateral sclerosis (ALS). Toward that end, she has been researching noninvasive ways to temporarily open the protective blood-brain barrier that now limits the delivery of most systemically-administered treatments for those diseases.
The Focused Ultrasound Foundation is supporting her work via a $100,000 research award that will enable Konofagou, an associate professor of Biomedical Engineering and Radiology at Columbia University in New York, to conduct a study that will explore the use of focused ultrasound in opening the blood-brain barrier opening to facilitate drug delivery in neurological and neurodegenerative diseases.
“The underlying hypothesis of this study is that delivery of therapeutic molecules is safe and effective through the blood-brain barrier using focused ultrasound,” Konofagou explains. “Our preliminary results have shown that the FUS technique can induce blood-brain barrier opening entirely noninvasively, selectively and be monitored with MRI at sub-millimeter resolution in vivo.” During the study, Konofagou will test and demonstrate delivery of neurotrophic factors to the hippocampus and putamen regions of the brain and assess the safety of the focused ultrasound method.
October 8, 2012
A record-setting 170 papers have been accepted for presentation at the 3rd International Symposium on Focused Ultrasound, and the final program is now available online.
Billed as “three days to change the world,” the September 7-9 Celebration of Science event in Washington, DC brought together more than 1,000 of the world’s most brilliant and influential individuals. In panels and talks, they gathered to share ideas and deliver the message that America should recommit itself to bioscience.
Focused ultrasound researchers are encouraged to submit abstracts to the 11th Biennial International Stereotactic Radiosurgery Society Congress which is scheduled for June 16-20, 2013 in Toronto, Canada.
The meeting will bring together professionals from around the world who are dedicated to the field of Radiosurgery, Stereotactic Body Radiotherapy and Novel Ablative Therapies for Brain tumours, such as focussed ultrasound.
November 4: 2013 is the ISRS Congress abstract submission deadline.
Abstract guidelines and submission
Seung-Schik Yoo, PhD, of Harvard Medical School and Ulsan National Institute of Science and Technology in Korea, and his colleagues have been pioneering the use of focused ultrasound in the neuromodulation of brain function, a pulse-mode approach they believe holds great therapeutic potential.
In a preclinical study published in the Journal of Controlled Release, Harvard Medical School researchers investigated the kinetics of blood-brain barrier permeability and drug delivery following single and double focused ultrasound sonications. They found that delivery of the chemotherapy agent, doxorubicin, was significantly greater when one focused ultrasound sonication was used and 1.5-fold higher when a second sonication was administered ten minutes later. Study data suggests that MRI contrast agent Gd-DTPA may be useful as a surrogate tracer in estimating drug delivery to the brain following focused ultrasound-induced blood-brain barrier disruption.
FasterCures has announced the availability of its new The Research Acceleration and Innovation Network (TRAIN) Inventory. The inventory, which lists the Focused Ultrasound Foundation, catalogues the operational and partnering practices of nonprofit disease research foundations, particularly those with a venture philanthropy focus. FasterCures says the inventory is designed to help potential collaborators better understand the landscape of disease research foundations and engage in meaningful partnerships with them.
View TRAIN inventory
French focused ultrasound device maker, EDAP TMS SA, reports that the two-year follow-up phase has concluded for its multi-center U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Data analysis is now underway, and the company is preparing a comprehensive Premarket Approval (PMA) submission, which is the next step in the FDA approval process.
Read press release
Don't miss out on early bird discounts that can save up to $100 on registration fees for the 3rd International Symposium on Focused Ultrasoud.
Sponsored by the Focused Ultrasound Foundation, the syposium is the only global forum dedicated to image-guided focused ultrasound and will be held October 14-17, 2012 in Bethesda, Maryland.
Discounts end at midnight EDT on August 31, 2012.
On July 23 and 24, the Focused Ultrasound Foundation's Brain Program hosted its first invitational mini-workshop to tackle important imaging problems with the help of a world-class team of MR experts from academia and industry. This highly successful workshop was a collaborative problem-solving session that generated solutions for improving the efficiency and safety of transcranial focused ultrasound treatments.
"Some of the solutions identified during the workshop will be applied in the very next brain patient procedure," says John Snell, PhD, Brain Program technical director. "The solutions are expected to reduce treatment time by improving the quality of the MRI scans."
On July 23 and 24, the Focused Ultrasound Foundation’s Brain Program hosted its first invitational mini-workshop to tackle important imaging problems with the help of a world-class team of MR experts from academia and industry. This workshop was a highly successful collaborative problem-solving session that generated solutions for improving the efficiency and safety of transcranial focused ultrasound treatments.
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
The Breast Cancer Society of Canada has donated $1 million to speed the development of a new microbubbles and ultrasound treatment for advanced localized breast cancer, an aggressive form of the disease that typically affects women 35-45 years old and has an extremely high mortality rate. The society provided the funding to the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto where pre-clinical studies are determining if combining microbubbles and ultrasound make breast tumors more responsive to chemotherapy and radiation. READ PRESS RELEASE
Through a visiting associate professorship funded by the Focused Ultrasound Foundation, one of the world’s leading ultrasonic therapy experts will spend the next eleven months collaborating with focused ultrasound researchers at the University of Virginia and with the Foundation’s Brain Program team. Jean-Francois (Jeff) Aubry, PhD, will be taking a leave of absence from Institut Langevin in Paris, France to engage in research that could improve focused ultrasound treatments for the brain. He will be an Associate Professor in UVA’s Department of Radiation Oncology from August 2012 through July 2013.
US biotech Celsion, Inc. will design and conduct a clinical trial in partnership with Oxford University (UK) to evaluate the use of its heat-activated drug, Thermodox, and ultrasound-guided high intensity focused ultrasound in treating patients with metastatic liver cancer. Patient treatments are expected to begin later this year. The study is supported by the National Institute for Health Research Oxford Biomedical Research Centre. It will be conducted as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering and the Oxford University Hospitals NHS Trust.
In an in-depth interview, Todd Mainprize, MD discussed MR-guided focused ultrasound and his efforts to use this exciting technology in treating brain tumors. Mainprize is a neurosurgeon at Sunnybrook
Hospital in Toronto and is a Surgeon Scientist affiliated with The Arthur and Sonia Labatt Brain Tumour Research Centre. READ STORY
During a June 9 workshop hosted by the Foundation’s Liver and Pancreas Program, 20 experts in the usage and research of focused ultrasound for liver ablation met to solidify views and formulate treatment recommendations.
Attendees, who included clinicians, scientists and industry representatives, developed a definition of “the clinical unmet need in the management of liver tumors." They also mapped out recommended structures for pilot and pivotal clinical trials and technical specifications for a liver treatment device. This information is expected to be published as either a white paper or a peer-reviewed article.
Matt Eames, PhD, senior project engineer for the Focused Ultrasound Foundation's Brain Program, filed this report from Heidelberg, Germany where he is attending the annual conference of the International Society for Therapeutic Ultrasound (ISTU):
A special highlight of the 2012 International Society of Therapeutic Ultrasound meeting was yesterday’s (June 12, 2012) presentation of the Fred Lizzi Early Career Award and the William and Frank Fry Award for outstanding contributions to therapeutic ultrasound. This year’s Lizzi Award was shared by two researchers, Constantin Coussios, PhD (University of Oxford, UK) and Nathan McDannold, PhD (Harvard University, USA). The Fry Award recipient was Gail ter Haar, PhD (Institute of Cancer Research, UK).
Following ISTU tradition, last year's award recipients delivered the Lizzi Award Lecture and Fry Award Lecture. Jean-Francois Aubry, PhD (Institut Langevin, France) delivered the Lizzi Lecture. His talk was entitled, "The Matrix," and described the optimal refocusing of an ultrasound wavefront through aberrating layers, with both transcranial and transcostal examples. In the Fry Award Lecture, Kullervo Hynynen, PhD (University of Toronto, Canada) delivered a lecture on the historical perspective on FUS, and closed with the conclusion that FUS needs clinical champions to achieve success as a fully reimbursed and accepted treatment modality.
Sonothrombolysis was a featured topic at the Sunday, June 10 session. Clot lysis research funded by the Focused Ultrasound Foundation was presented by Stephen Monteith, MD of the University of Virginia. Monteith, who uses the InSightec ExAblate system, described his success lysing blood clots in an in-vitro experimental setup and how this led to a pre-clinical trial involving the treatment of intracerebral hemorrhage (ICH) in pigs. Dr. Monteith went on to present preliminary results from the lysis of ICH blood clots in a human cadaveric model.
Also of note was a persuasive argument from Dr. Bill Culp of the University of Arkansas for Medical Sciences to move towards clinical trials for ischemic stroke. There was also a presentation from Cerevast on their upcoming Phase III clinical trial for a battery-powered, unfocused ultrasonic head transducer to enhance tPA delivery and/or provide more expedient, ambulance-based treatment to stroke patients. More information on this study may be found on ClinicalTrials.gov.
Celsion Corporation and Philips Healthcare have resubmitted an Investigational New Drug/ Investigational Device Exemption application with the U.S. Food and Drug Administration for a Phase II patient study. The trial will evaluate a combined therapy using Celsion's liposome encapsulated drug, ThermoDox, and the Philips Sonalleve MR-guided high intensity focused ultrasound system for the treatment of prostate cancer metastasizes to the bone. The study is set to launch following FDA acceptance of the proposed program. Read press release.
A neurosurgery team at Sunnybrook Health Sciences Centre in Toronto has successfully treated the first patient enrolled in a clinical trial assessing focused ultrasound as a therapy for essential tremor. Funded by the Foundation, the study is open to residents of Canada and is expected to treat six patients. For more information, contact research coordinator Karen Ng at 416-790-0809.
A team led by Sanjiv Sam Gambhir, MD, PhD at Stanford University has received a $100,000 research award from the Focused Ultrasound Foundation to develop an innovative early detection technique for tumor masses. The approach will use focused ultrasound to facilitate the release and detection of blood biomarkers.
LAWRENCEVILLE, NJ and CHARLOTTSVILLE, VA – May 1, 2012 – Celsion Corporation (NASDAQ: CLSN) and the Focused Ultrasound Foundation announced today their support for preclinical studies designed to explore the use of ThermoDox®, Celsion’s Phase III, proprietary, heat-activated liposomal encapsulation of doxorubicin, in combination with MR-guided high intensity focused ultrasound (HIFU) for the treatment of pancreatic cancer. The studies are being conducted at the University of Washington School of Medicine by Joo Ha Hwang, M.D., Ph.D., Director, Endoscopic Research, Associate Professor of Medicine and Adjunct Associate Professor of Bioengineering and Radiology.
As Dennis Parker, PhD and his colleagues at the University of Utah continue to refine and advance their new HIFU system for breast tumors, they have also joined forces with Swiss and French researchers to solve the technical problems of measuring temperature changes during focused ultrasound treatments.
In designing their system, the Utah team has come up against significant technical challenges. For example, they had to determine how to measure temperature changes in fatty tissues, adjust for motion-related errors and cover larger volumes at acceptable spatial and temporal resolution. Their quest for solutions led to a collaboration with University of Geneva researchers who are addressing similar problems in developing a HIFU system for liver tumors. The Foundation supported this collaboration through a $100,000 Research Award for a project entitled, “Robust MR thermometry for MRgHIFU in breast and liver.” (Click here to read a previous newsletter report about that project.)
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
A study published in this month's Lancet has received a lot of media attention, getting recogniztion in such outlets as the Time, UK Telegraph, Businessweek, Marketwatch, and more.
The study, Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study, details the results of 42 patients treated with the Sonoblate HIFU system in their phase 2 clinical trial.
Research activities at the Foundation’s first Center of Excellence, located at the University of Virginia, have once again made national news. The Center’s Research DirectorRichard J. Price, PhD and his collaborator at Johns Hopkins University,Justin Hanes, PhD, have received a $3.3 million, five-year grant from the National Cancer Institute at the National Institutes of Health. The grant will enable the researchers to continue developing new, focused ultrasound-mediated treatments that deliver drugs across the blood-brain barrier (BBB), the membrane that prevents foreign substances – such as chemotherapies – from entering the brain.
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.”
Epilepsy Research UK reports that Ultrasound 'researched as epilepsy treatment.'
John Grisham, a novelist known worldwide for more than 20 best-selling legal thrillers, will be the keynote speaker at the 3rd International Symposium on the Current and Future Applications of Focused Ultrasound on October 14-17, 2012 at the Bethesda North Marriott Hotel and Conference Center in Bethesda, Maryland, USA. Grisham serves on the Board of Directors of the Focused Ultrasound Foundation, which is hosting the symposium to highlight advances for the global research and clinical community.
In an effort that is being led by Dr. Larry Crum, a member of the Foundation's Research Advisory Committee, a new technique is being developed to use focused ultrasound to position kidney stones into better placement so that the body can pass them.
FUS Foundation Research Awardrecipient Lili Chen, PhD has published a second paper related to her preclinical studies of focused ultrasound’s ability to enhance the delivery of chemotherapy to advanced prostate tumors. Entitled, “MR-guided pulsed high intensity focused ultrasound enhancement of docetaxel combined with radiotherapy for prostate cancer treatment,” the paper appears in the January 21, 2012, issue (Vol. 57, No. 2) of Physics in Medicine and Biology. Chen, who is an associate professor and medical physicist in the Radiation Oncology Department of Fox Chase Cancer Center in Philadelphia, published her first paper in the November 2010 issue of that same journal.
This month’s featured focused ultrasound researcher, Urvi Vyas, PhD, has made important contributions in the area of ultrasound beam propagation. Realizing that many newsletter readers may not be familiar with this process, we asked, Matthew Eames, PhD, a biomedical engineer and Senior Project Engineer for the FUS Foundation Brain Program, to provide an explanation. Here’s what he wrote:
Researcher interview: Urvi Vyas, PhD, Stanford University
A highlight of the FUS Foundation’s 2010 International Symposium on MR-guided Focused Ultrasound was the presence of our Young Investigators, ten early-career scientists selected to present their work during oral or poster sessions. The spirit and enthusiasm of these individuals provided a special spark that energized the entire symposium.
During a recent interview, one of those Young Investigators – Urvi Vyas, PhD – provided an update on her focused ultrasound activities. The excitement and positive expectancy with which she spoke were truly inspirational.
Vyas, who is now a post-doctoral fellow at Stanford University, earned her PhD in bioengineering at the University of Utah. Professionally, her main interests are ultrasound beam propagation and MR-guided focused ultrasound surgery. Like many of the unsung heroes in the field of focused ultrasound, she is working behind the scenes to address technical issues and challenges that will make new patient treatments possible.
What is ultrasound beam propagation? Click here to find out.
After completing her undergraduate degree in bioengineering at Shree Govindram Institute of Technology and Science in India, Vyas joined Utah’s bioengineering program where she helped develop an NIH-funded focused ultrasound system for breast cancer. That project enabled her to learn from three individuals she describes as mentors: ultrasound expert Douglas Christensen, PhD,MR leader Dennis Parker, PhD, and biothermal specialist Robert Roemer, PhD.
“I think this is an exciting field because you need so many people to come together to make a system work. You need temperature measurements. You need the ultrasound to work. You need to control the ultrasound. Not only that, you need to control the heating and so you need somebody that knows the bioheat transfer equation,” Vyas observes.
Focused ultrasound system for the breast
In creating a focused ultrasound system for the breast, the Utah team had to break new ground in a number of areas: measuring temperature in the breast, planning patient treatments and designing a transducer. “Where I came in was the ultrasound part of all of this,” says Vyas.
She worked on developing fast simulations for ultrasound beam propagation. “We went from a time scale of a couple of hours to simulate one beam propagation pattern to a few seconds. This was on a grad student laptop, so this was really exciting. Once we had that working, we could then design patient-specific treatment plans. We’d take an MR image of the patient and then design a treatment plan that would fit this particular patient,” she explains.
After helping to reduce treatment planning time, Vyas got involved in designing an ultrasound transducer for the breast. “We designed various configurations and figured out that the side-shooting transducer would work best for the breast,” she says.
Her next task was using fast beam propagation simulation to solve an inverse problem. “In the forward problem, I can simulate where the beam is going to be. I can also do the inverse problem. I can see the temperature and figure out what the tissue properties for this particular person are because it’s very hard to measure acoustic properties of a human being without cutting the human being open,” she says.
Solving the inverse problem lead to a first-time in vivo study in which the Utah team demonstrated that the acoustic properties of muscle could be measured noninvasively with focused ultrasound. This work qualified Vyas for the FUS Foundation’s Young Investigator Award and for an award from the Society for Thermal Medicine.
At Stanford, Vyas is working with Kim Butts Pauly, PhD, a leader in MR thermometry. Her energies are now being directed to correcting trans-cranial phase aberration. “When you put the ultrasound beam through the skull, there are a lot of aberrations because of the skull having different thicknesses,” Vyas explains. “The plan is to use the acoustic radiation force imaging and figure out how to better correct these aberrations in the brain.”
Although the clinical applications of this approach have not yet been determined, Vyas hopes it will be widely useful. “I think what we want to do is give the field a very efficient, fast way of doing phase aberration correction and just share it with everybody,” she says.
Vyas is inspired by the thought of patients benefitting from her work. “When you’re in a lab typing code on a computer, you don’t realize what it may lead to,” she says. Attending the FUS Foundation’s recent Brain Workshop gave her a glimpse of the impact her work could have on patients. There, she heard doctors talking about treatment envelopes based on simulations she helped develop. “These treatments are going to be in clinics really soon, and it’s very exciting,” she exclaims.
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.”
The last of 15 patients was treated in mid-December in the world’s first clinical trial using MR-guided focused ultrasound as a therapy for essential tremor. The single-site pilot study, which has been funded by the FUS Foundation, began in February 2011 at the University of Virginia with neurosurgeon W. Jeffrey Elias, MD serving as principal investigator.
All study participants are being followed for three-months, and final clinical trial data is expected to be available in March 2012. Elias will present that data at the 2012 American Association of Neurosurgeons meeting, scheduled for April 14-19.
Preliminary study data, which was presented by Elias at the 2011 Congress of Neurological Surgeons meeting in October, was highly promising. The study’s first 10 patients experienced a 78 percent improvement in contralateral tremor scores in their dominant hand, as assessed with the Clinical Rating Scale for Tremor (CRST). Patients’ functional activities scores improved by 92 percent, as measured in the ‘Disability’ subsection of the CRST. Elias said that outcomes and complications were comparable to other procedures for tremor, including stereotactic thalamotomy and deep brain stimulation.
Audio/slide presentations by W. Jeffrey Elias, MD and his clinical team at the University of Virginia are now available for viewing on the FUS Foundation website. These talks provide a wealth of background information and were given at a special event organized in September 2011 by the Essential Tremor Support Group in Charlottesville, Virginia. Presentations are listed in the order in which they were given at the event.
The visibility of focused ultrasound is skyrocketing. TIME Magazine has named it one of the 50 most inspired ideas, innovations and revolutions of 2011. In its coverage, TIME heralds MR-imaging and focused ultrasound "remarkable in their own right"and observes that "something life-changing" emerges when the two are combined.
Researcher interview: Seung-Schik Yoo, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
Focused ultrasound researcher, Seung-Schik Yoo, PhD, is driven by a desire to help people with brain disorders. As leader of the Neuromodulation Working Group formed by the FUS Foundation’s Brain Program, he is collaborating with a multinational, multi-disciplinary team consisting of 27 specialists in neuroscience, physics, biomedical engineering and imaging. Their goal is to determine how pulsed, low intensity focused ultrasound can be used to assess region-specific brain functions and to modify and control aberrant brain activities.
Nearly 80 leading scientists, researchers, public health officials and industry executives from 12 countries and 30 different institutions participated in the FUS Foundation’s third invitational Brain Workshop from October 23 to 26.
With 46 presentations on the agenda, this year’s workshop provided an in-depth progress report on the status of the Brain Program and the work ahead. As FUS Foundation Chairman Neal Kassell, MD told attendees, “Our primary interest is to rapidly advance the development and adoption of reimbursable applications that either fulfill an unmet clinical need or are significantly better than existing therapies in terms of outcomes, cost and convenience.”
UPDATE:Videos from the presentation at TEDMED 2011 have now been released!
InSightec notified the Foundation with the following information this afternoon:
"This morning, California time, Dr. Yoav Medan, Chief Systems Architect of InSightec,delivered an invited talk on MRgFUS at TEDMED 2011 in San Diego.
Well-known focused ultrasound researcher Nathan McDannold, PhD, of Harvard Medical School, is scheduled to discuss the use of MR-guided focused ultrasound in delivering cancer drugs across the blood-brain barrier at the Society of Neuro-Oncology Annual Meeting, scheduled for November 17-20 in Orange County, California. This year's meeting is being held in conjunction with the AANS/CNS Section on Tumors.McDannold's talk, entitled, "MRgFUS induced blood brain barrier disruption and novel drug delivery for brain tumors," is scheduled for presentation during the society's Education Day on November 17."This is the first time that SNO has included a discussion about MRgFUS in its annual meeting,"said Jason Sheehan, MDa neurosurgeon who is co-chair of Education Day and co-director of the Focused Ultrasound Center at the University of Virginia. ”We're hoping that this will help educate participants about the emerging role of MR-guided FUS in neuro-oncology."
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.
By Joy Polefrone, PhD, Focal Drug Delivery Program Director
Inspired by the FUS Foundation’s symposia in 2008 and 2010, the Sapienza University of Rome organized the 1st European Symposium on Focused Ultrasound Therapy. Held from September 22-23, the meeting was a great success with more than 200 people present. Program content was excellent and covered current and future applications of both MR-guided and ultrasound-guided focused ultrasound technology. The agenda included three invited presentations by FUS Foundation staff members and spotlighted some of our funded researchers as well.
The FUS Foundation-funded clinical trial at the University of Virginia attained a new milestone this month when its principal investigator, W. Jeffrey Elias, MD, presented preliminary study findings at the Congress of Neurological Surgeons meeting in Washington, DC.
Results to date show that the study’s first 10 patients had a 78 percent improvement in tremor scores in their hand, as assessed with the Clinical Rating Scale for Tremor (CRST). Their functional activities scores improved by 92 percent, as measured in the ‘Disability’ subsection of the CRST. Elias said that outcomes and complications were comparable to other procedures for tremor, including stereotactic thalamotomy and deep brain stimulation.
Patient enrollment is underway for the first US-based study comparing MR-guided focused ultrasound and uterine artery embolization (UAE) for the treatment of uterine fibroids. The study, called The Fibroid Interventions: Reducing Symptoms Today and Tomorrow (FIRSTT) trial, is now open at the Mayo Clinic in Rochester, MN and at Duke University in Durham, NC. Study participants will be randomly assigned for treatment with either FUS or UAE.
Expected to provide important insights regarding the benefits and potential drawbacks of newer non-surgical treatment approaches for uterine fibroids, the study will follow patients for three years. Its goal is to assess how effective treatments are in symptom relief, side effects, impact on women's quality of life, need for additional treatment, potential for future fertility and even the costs associated with each approach.
The FUS Foundation's Center of Excellence Program is preparing to expand. Our next designated site will soon be announced and embody the same multi-disciplinary, collaborative approach and commitment to pushing the R&D envelope as found at our first Focused Ultrasound Center of Excellence, which celebrated its second anniversary this month.
Many readers of this newsletter know about TEDMED, the annual high-profile, mover and shaker event. It brings together a roster of health, information and technology professionals and pioneers who share their personal stories and spotlight developments and ideas that are shaping healthcare's future. Key goals of TEDMED are to give thought leaders from various disciplines and industries an opportunity to learn from each other and to collectively address major problems in healthcare.
Elizabeth Stewart, M.D., of the Mayo Clinic in Rochester, MN, USA, was recently honored for her research on MR-guided focused ultrasound therapy and its effects on future fertility in women with uterine fibroids. On September 8, the Royan Institute – a non-profit, non-governmental research institute in Tehran, Iran – presented Stewart with a Royan International Research Award in the category of Female Infertility and Reproductive Imaging.
Researchers who have submitted abstracts and been invited to submit full proposals to the FUS Foundation's Research Awards Program are reminded that their original or revised input must be received by October 1 in order to be considered for funding during the first quarter of 2012. Proposals received after the submission deadline will automatically be deferred to the next funding cycle.
The Research Awards Program, which received a record number of proposals last quarter, continues to accept and review abstracts on a rolling basis. However, the program's independent Research Advisory Committee only reviews full proposals and makes funding recommendations on a quarterly basis.
Submission deadline:July 1, 2011October 1, 2011January 3, 2012April 1, 2012
Notification of funding decision:October 1, 2011 (pending)January 3, 2012April 1, 2012July 1, 2012
Abstract submissions were set to close last week for the 1st European Symposium on MR-guided Focused Ultrasound Therapy. Organized by the Department of Radiology of the University of Rome La Sapienza, the symposium will be held September 22 and 23, 2011 in Rome.
Celsion Corporation recently announced it is moving its headquarters from Columbia, MD to Princeton, NJ. An article published in yesterday’s Baltimore Sun asserts that the move is prompted by the lack of a labor pool in Maryland with experience in marketing, selling and distributing pharmaceuticals.
In addition to sponsoring clinical trials that are assessing its heat-sensitive drug, Thermodox, as a treatment for liver and breast cancer, Celsion is working in partnership with Philips Healthcare to develop a new focal drug delivery treatment for metastatic bone cancer. The method combines ThermoDox with Philips’ MR-guided focused ultrasound technology.
Researcher interview: Hyun S. (Kevin) Kim, MD, Emory University, USA
However, two new challenges quickly arose: gaining widespread physician adoption and insurance reimbursement. Both are needed to build traction against established surgical procedures – such as hysterectomy – and newer less-invasive approaches. Both require the availability of evidence demonstrating long-term patient benefits.
According to a story recently published by the UK-based Daily Mail Online, researchers have successfully treated 15 patients using MRgFUS for facet joint-related back pain in a clinical trial at St. Mary’s Hospital in London.
During the treatment, the patient lies in an MRI scanner while doctors deliver beams of ultrasound to the nerves of the facet joints, using images from the scanner to position the beams. The low-energy sound waves do not damage healthy tissue but are angled by the physicians so that they cross over each other at the position of the facet joints, numbing the nerves.
Researchers reported that the focused ultrasound treatment resulted in a 62 percent decrease in pain and a 55 percent decrease in disability.
MRgFUS shows promise as a viable option for facet joint back pain, particularly in cases that may be resistant to other treatments.
Read the article.
Twenty-three patients with organ-confined, low-risk prostate cancer have been treated with MR-guided focused ultrasound in clinical trials, showing promising initial results.
The goal of the trials is to demonstrate the feasibility of using the ExAblate® MR-guided Focused Ultrasound (MRgFUS) system in endorectal prostate treatments and to assess the safety and preliminary effectiveness of the treatment. The trials were approved by local ethic committees.
A study recently published in the journal Academic Radiology shows positive outcomes up to three years following treatment of uterine fibroids with MR-guided focused ultrasound.
In the study, 40 women with fibroids were treated with focused ultrasound. Researchers followed up with the women at three and six months, as well as one, two and three years. They found that the largest decrease in fibroid size occurred within the first six months and continued to happen over the three-year period.
On June 14, 2011, GE Healthcare Korea and InSightec, Ltd. co-hosted a conference to recognize two important developments in the focused ultrasound community.
First was the attainment of the 500-patient mark by the focused ultrasound team at CHA Bundang Medical Center in Seoul. Under the leadership of Sang-Wook Yoon, MD, the team has been treating uterine fibroid patients for five years. CHA’s one-year follow up data shows that 95% of patients have experienced improvement and that 18 have either become pregnant or given birth.
The second development acknowledged at the event is the purchase of ExAblate brain and body systems by Yonsei University Medical Center. Jin Woo Chang, MD will use the new brain system to conduct the world’s first clinical trial in which patients with obsessive compulsive disorder (OCD) will receive MR-guided focused ultrasound therapy. Yonsei researchers are also planning clinical trials involving patients with metastatic bone tumors, low-risk and intermediate risk prostate cancers, essential tremor, and brain cancer.
FUSF Research Award recipient: Nathan McDannold, Harvard Medical School, USA
Nathan McDannold, PhD, started working in focused ultrasound research as a physics graduate student in 1996. “I was looking for a medical physics project and sort of stumbled into the field,” he recalls.
Hypoxic (oxygen-deprived) tumor cells usually resist radiation and chemotherapy, making them a key challenge in treating cancer. Researcher Xin Chen, PhDbelieves that MR-guided focused ultrasound could reduce this problem, benefiting patients with malignant solid tumors in areas such as the liver, prostate and breast.
Chen, who is an assistant professor in the Department Radiation Oncology at University of Arkansas for Medical Sciences, has received a $100,000 Research Award from the Focused Ultrasound Surgery Foundation. He is exploring the feasibility of a new method that will detect the hypoxic areas in tumors and use MR-guided focused ultrasound to selectively ablate them prior to regular radiation therapy.
Studies are recruiting patients with essential tremor, brain tumors
The Focused Ultrasound Surgery Foundation has announced it is funding two new clinical trials at Sunnybrook Health Sciences Centre in Toronto. The studies will evaluate the feasibility and safety of MR-guided focused ultrasound as a treatment for essential tremor and malignant brain tumors. Performed under protocols approved by Health Canada, the noninvasive treatments will be administered through patients’ intact skulls, and study participants will remain awake – no anesthesia will be administered. The Sunnybrook team will follow each patient’s progress for three months with contrast MRI and clinical examinations.
Just wanted to let everyone know that the as of yesterday, we had received 11 new abstract submissions this quarter for the Research Awards Program. This is the highest quarterly submission number we have seen since the program’s inception in 2007! The full proposals are also coming in at record pace for the July 1st submission deadline.
Hannah Edelen, JDDirector, Research & Fellowship ProgramsFocused Ultrasound Surgery Foundation
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.
On June 13, the Richmond Times Dispatch provided an update on the FUS Foundation-funded essential tremor trial at the University of Virginia and its first participant, Billy R. Williams. Written by Lifestyles reporter Tammie Smith, the story was prompted by a reader's inquiry about how Mr. Williams is doing.
Williams, who has completed the three-month study period, reports he is doing well. His UVA neurosurgeon, W. Jeffrey Elias, MD, says Williams has demonstrated excellent tremor control. Click the link below to read the full story.
Early results of essential tremor study promising - http://www2.timesdispatch.com/lifestyles/2011/jun/13/TDMET05-early-results-of-essential-tremor-study-pr-ar-1103913/
I recently attended the Society for Thermal Medicine's Annual Meeting in New Orleans, LA. Throughout the meeting it became abundantly clear that there is a rationale for clinical applications of mild hyperthermia -- especially with the significant number of phase III clinical trial data shown in an overview presentation given by Elizabeth Repasky, Ph.D. from Roswell Park Cancer Institute, as well as presentation of work by the leading clinical group from Munich of Prof. Dr. Rolf Issels, M.D. and Dr. Lars Lindner. A randomized phase III clinical trial performed by Issels and Lindner was recently published in Lancet Oncology and showed a significant survival benefit when mild hyperthermia (heating to ~42 °C) is delivered in combination with chemotherapy and radiotherapy.
Russian-born Natasha Rapoport, Ph.D., a research professor of bioengineering at the University of Utah, knows something of pain and trauma. Her physician father, Yakov, was jailed in 1953, wrongly accused in an infamous, yet fictitious “Doctor’s Plot” to assassinate Stalin. Natasha was 14 when she opened the door and her beloved papa was whisked away to be manacled and interrogated. Yakov Rapoport survived, and both father and daughter later wrote memoirs. Yakov has died, and Natasha has traded the Moscow forests for Salt Lake’s desert. But she carries on the family scientific tradition in a quest to make currently fatal pancreatic cancer a chronic, or even curable, disease.
The call for abstracts opened on May 30 and will close on July 29 for the 1st European Symposium on MR-guided Focused Ultrasound Therapy. Organized by the Department of Radiology of the University of Rome La Sapienza, the symposium will be held September 22 and 23, 2011 in Rome.
Directed to physicians of various sub-specialties, physicists and basic scientists throughout the European Community, the symposium seeks to bridge the gap between basic research and clinical activity. Topics being covered by its faculty of global thought leaders and researchers include: technology, brain, breast, bone tumors, liver, pancreas, prostate, uterine fibroids, targeted drug delivery. The symposium will conclude with an oncology round.
Serving as Symposium Presidents are Roberto Passariello M.D., Professor of Radiology and Chairman, Department of Radiology at Sapienza University of Rome and Neal F. Kassell, M.D., Professor of Neurosurgery at the University of Virginia and Founder of Focused Ultrasound Surgery Foundation, which is a conference sponsor.
In addition to Passarriello, the symposium organizing committee consists of two other members of Sapienza's Radiology Department: Carlo Catalano, M.D., Vice Chair and Head of CT and MR Sections and Alessandro Napoli, M.D., Ph.D., Head of MR-guided FUS Unit.
Complete information about the symposium >
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.
Thanks to the generosity of FUS Foundation donors, the disbursements from our Research Awards program recently passed the $2 million mark. This funding has gone to 20 investigator-initiated projects ranging from preclinical research to pilot clinical trials using noninvasive MR-guided focused ultrasound. Awards are typically $100,000 for a 12-month period and have enabled investigators to explore new treatments ranging from breast, liver and pancreatic cancer to functional brain disorders and chronic back pain caused by facet joint disease. To read our full press release, click http://www.fusfoundation.org/Press-Releases/fus-foundation-research-award-disbursements-top-2-million
Focused Ultrasound Surgery Foundation reports research award
disbursements have topped $2 million
Surge in applications necessitates funding cycle changes
FUSF Research Award recipient: W. Jeffrey Elias, M.D, University of Virginia, USA
Neurosurgeon W.Jeffrey Elias, M.D. first learned about the promise of MR-guided focused ultrasound a few years ago from colleague Neal F. Kassell, M.D. at the University of Virginia. At first, Elias was intrigued but, well, maybe a little busy. He was absorbed in a growing practice and had new twins at home. But he seized the chance to study the technology when UVA opened its Focused Ultrasound Center. “I realized it was going to be a very unique opportunity for us to be involved in early and innovative research,” Elias remembers.
Mario Ries, Ph.D., a physicist at the Laboratory for Functional and Molecular Imaging in Bordeaux, France, has been intrigued with the notion of combining noninvasive ablation with MR guidance since 1997. Today, his key ambition is help the roughly one to one and a half million people globally diagnosed with breast cancer every year.
Ries has received a $100,000 research award from the Focused Ultrasound Surgery Foundation to pursue a project he believes will result in a safer and more effective treatment for breast cancer. His objective is to solve the technical drawbacks that cause existing high intensity focused ultrasound (HIFU) transducers – devices that convert energy into sound waves and focus the waves on a target – to damage tissue around the breast, including to the thoracic cage, heart and lungs.
Russian-born Natasha Rapoport,Ph.D.,a research professor of bioengineering at the University ofUtah, knows something of pain and trauma. Her physician father, Yakov, was jailed in 1953, wrongly accused in an infamous, yet fictitious “Doctor’s Plot” to assassinate Stalin. Natasha was 14 when she opened the door and her beloved papa was whisked away to be manacled and interrogated. Yakov Rapoport survived, and both father and daughter later wrote memoirs. Yakov has died, and Natasha has traded the Moscow forests for Salt Lake’s desert. But she carries on the family scientific tradition in a quest to make currently fatal pancreatic cancer a chronic, or even curable, disease.
Interview with Wladyslaw Gedroyc, M.D., St. Mary’s Hospital, London, England
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.
“The follow-up data that we have collected is very promising, with up to 60 percent reduction in pain and a similar level of reduction in the level of disability, as measured by NRS and Oswestry Disability Index scores,” Gedroyc says.
The start date of the clinical trial will be determined following the approval of the study protocol by the ethics committee at St. Mary’s Hospital.
Gedroyc says, “It is difficult to estimate how many people suffer from facet joint disease because chronic back pain is large mish-mash of many pathologies. One of the big problems is that people are often treated for facet disease when they may have other problems of the back.”
For this reason, the studies at St. Mary’s only recruit patients who have demonstrated a definite response to a previous facet intervention. “By a ‘facet intervention’ I mean something like a local anesthetic or steroid injection close to the facet join, or a joint injection of steroids, or possibly a radiofrequency ablation of the nerves around there,” Gedroyc explains. Radiofrequency ablation, he says, is the current gold standard for facet joint treatment.
The new technique uses MR-guided focused ultrasound to destroy nerve structures in degenerative facet joints. “We simply heat up the facet joints with focused ultrasound in a noninvasive manner so that we destroy the nerve bundles along the posterior aspect of the facet joint,” Gedroyc says. “We believe these nerve bundles are instrumental in causing pain from facet joint disease.”
If clinical trials are successful, he adds, “It means that we will have created a method of treating facet joints with an entirely noninvasive modality. No radiation will be involved. Just an MR scan using focused ultrasound. So, the patient would come in, lie down on the table, we would treat probably three facet joints on each side, and they will walk out. And we anticipate that we could do this in about half an hour or so. If it is long-lasting, then we have a huge potential for improving the way patients are treated, requiring no more injections.”
Key developments and information related to the randomized clinical trial at St. Mary’s will be covered in future issues of this newsletter.
ISTU meeting highlight: ultrasound-based neurostimulation presentation
Matt Eames, Ph.D., Senior Project Engineer for the FUS Foundation’s Brain Program, filed this blog following the recent ISTU 2011 meeting, held April 11-13 in New York City:
Among many interesting invited talks at this year’s ISTU in Manhattan was that of William Tyler, Assistant Professor of Biomedical Engineering and Science at Virginia Tech (http://www.vtc.vt.edu/research/faculty/william-jamie-tyler.html), on the topic of ultrasound-based neurostimulation. Dr. Tyler, a prominent member of the FUS Foundation’s Collaborative Research Network, presented a fast-paced talk explaining the mechanics of neurotransmitters and synaptic junctions, and how this knowledge led him to explore the use of ultrasound – as opposed to transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) – as a non-invasive means to disrupt or alter neuronal function. While still in the research realm, it is hoped that the regulatory approval environment for clinical procedures based on this technology will be relatively straightforward due to the extremely
The Focused Ultrasound Surgery Foundation has set the date and location for the 3rd International Symposium on MR-guided Focused Ultrasound. The meeting will be held October 14-17, 2012 at the Bethesda North Marriott Hotel & Conference Centerin Bethesda, MD, USA.
Profound Medical Inc. (PMI) and Siemens Healthcare have announced plans to conduct a global, multi-site, human safety/feasibility clinical trial initiative involving early stage prostate cancer patients in Europe, the U.S. and Canada.
In making the announcement, PMI's CEO Paul Chipperton observed, "We are developing a truly unique, minimally-invasive medical device for the treatment of prostate cancer, combining the already proven clinical efficacy of ultrasound thermal therapy with the unparalleled imaging capabilities of MRI." He had previously said that the new device has the potential to treat patients three to six times faster than existing options with greater accuracy and fewer side effects.
While most focal drug delivery research is still in the preclinical stage, the field's frontrunner, Celsion Corporation, has requested FDA permission to launch U.S. clinical trials of its investigational liposome-encapsulated drug, ThermoDox. Conducted in partnership with Philips Healthcare, those studies will investigate the use of ThermoDox in focused ultrasound-mediated drug delivery treatments for patients with metastatic bone cancer. Read more.
The last ten years have been challenging for Billy R. Williams of Fort Valley, Virginia. The former Pentagon employee, who survived the 9/11 terrorist attack, has suffered from essential tremor, a progressive and debilitating neurological disorder.
Medications controlled his tremor for a while, but eventually the shaking became so severe that Williams found it impossible to do anything with his dominant right hand. He was unable to button his shirt, eat without spilling or fill in a crossword puzzle. An avid golfer, he even needed help teeing up his ball. Referred to the University of Virginia for evaluation, he learned about various treatment options and ultimately agreed to participate in a new clinical trial. Funded by the FUS Foundation, the study is assessing the safety and initial efficacy of noninvasive MR-guided focused ultrasound as a treatment for essential tremor.
On February 25, 2011, Williams became the first essential tremor patient in the world to receive MR-guided focused ultrasound therapy, and the results were dramatically positive.
- Written by Ellen C., McKenna
Study InformationClick here for study information posted on the National Institutes of Health website. Patient inquiries can be directed to UVA Neurosurgery Clinical Trials at 434-243-1435 or by emailing
Click here to read FUS Foundation newsletter coverage of this study >
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As a researcher, Nathan McDannold, Ph.D. is on a quest to improve the delivery of drugs to the brain. “Most drugs don’t actually get into the brain when you inject them into the body or if a person takes a pill because of the blood-brain barrier,” he explains. “It places a big limitation on what drugs you can use.”
In preclinical studies a decade ago, McDannold and his colleagues made an important discovery: the blood-brain barrier (BBB) could be temporarily disrupted without causing damage. Doing so involved the use of pulsed, low power ultrasound combined with small microbubbles filled with a contrast agent for ultrasound imaging.
Since then, McDannold’s goal has been to translate this discovery into safe and effective patient therapies that not only treat brain disorders but also precisely target where drugs are delivered. He is now investigating the use of MR-guided focused ultrasound in opening the BBB. The approach has so far proven successful and safe in large animal models.
Encouraging research has also been performed by Eun-Joo Park, Ph.D., a research fellow on McDannold’s team. “She looked at treating breast cancer metastases in the brain using Herceptin,” McDannold explains. “A lot of patients get breast cancer, and they respond well to drugs. But when it metastasizes to the brain, they don’t respond to the drugs very well anymore. So, we hope that by disrupting the blood-brain barrier in the tumor and around it, we can get drugs into the brain and help these patients.”
McDannold envisions many brain disorders benefitting from focal drug delivery. “There are some results in animals showing that we can actually clear out some of the plaques that are formed in Alzheimer’s. There are other applications for diseases like Parkinson’s or multiple sclerosis, potentially,” he observes. “This stuff is really wide open for us to look at. We’re just sort of scratching the surface and developing the technology that will enable a lot of other research.”
A recent publication by Holger Grüll, Ph.D. and his colleagues has been hailed as an important development in the SonoDrugs project. Launched in November 2008, SonoDrugs is a multinational, 15-partner research consortium backed by the European Union’s Seventh Framework Programme (FP7) and aimed at holding the line on healthcare expenditures while providing access to state-of-the-art medical care. The consortium is developing new therapeutic options for cancer and cardiovascular disease that offer greater efficacy, reduced side effects, fewer burdens on the patient and faster recovery times than existing treatments.
SonoDrugs researchers are combining MR imaging, ultrasound and liposome technologies to develop delivery methods that release drugs locally at the diseased tissue site. These methods are designed to be triggered by focused ultrasound induced pressure or temperature stimuli.
The paper by Grüll and his colleagues, “Magnetic resonance imaging of high intensity focused ultrasound mediated drug delivery from temperature-sensitive liposomes: An in vivo proof-of-concept study,” was published in the February 2011 Journal of Controlled Release. Its key findings were: 1) local delivery improves drug uptake in tumors and 2) drug uptake can be visualized and measured by MR imaging in real time.
The preclinical research used temperature sensitive liposomes and a combination of MR imaging and ultrasound technologies for local delivery of chemotherapy. The liposomes contained doxorubicin and a clinically used contrast agent based on gadolinium. Because it could be tracked by MR imaging, the contrast agent enabled researchers to visualize and monitor drug uptake in the tumor and surrounding tissue in real time.
Real time capability is expected to be a significant advancement when this new method enters clinical use. It will enable physicians to determine if a tumor is absorbing sufficient chemotherapy or if additional or alternative treatment is needed. Insufficient drug absorption can occur in tumors with poor blood supply, which cannot be detected during existing cancer treatments.
Although encouraged by the findings, Grüll says, “I would like to be yet cautious about the translational value of our approach. We are dealing with a formulation that contains a gadolinium-based contrast agent and doxorubicin, so we have to first make sure about toxicity and toxicity profiles. Many things have to be sorted out and much more work has to be done in the preclinical space before we can bring this approach further in the direction of the clinic.”
He adds, “Preclinical studies are now determining if improved drug delivery enhances survival rates. I hope that within the next year we will have that data.”
Ultimately, Grüll believes that temperature induced drug delivery will become an important special application for cases that cannot be address with conventional approaches. “I think the technique has strong value for metastatic tumors that are localized and confined. For example, it may be a good option for pancreatic cancer or liver cancer patients who have a localized tumor that cannot be treated in any other way.”
Focal Drug Delivery Workshop Supercharges Research and Development Community
Held March 21-23, 2011, the FUS Foundation’s first Focal Drug Delivery Workshop marked a major milestone in the field of MR-guided focused ultrasound and set the stage for advancing a new generation of personalized medical treatments for cancers of the brain, pancreas and liver. New drug delivery treatments for both Alzheimer’s and Parkinson’s diseases are expected to quickly follow.
While others explore the ablative potential of MR-guided focused ultrasound to treat early-stage prostate cancer, Lili Chen, Ph.D., has been assessing the technology's ability to enhance chemotherapy delivery to more advanced prostate tumors. Her recent study, which was supported by a Research Award from the FUS Foundation, was published in the November 2010 issue of Physics in Medicine and Biology.Click here to read full report.
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