CHARLOTTESVILLE, VA (June 22, 2011) - On June 12, 2011, viewers of the CBS Evening News learned about Stephanie Small’s gripping story. Suffering from a large uterine fibroid, the 27 year-old was treated last December as part of a MR-guided focused ultrasound clinical trial at the University of Virginia in Charlottesville.
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Small says her focused ultrasound treatment changed her life. She experienced symptom relief within a few days and reports that her quality of life has steadily and significantly improved. “I think focused ultrasound surgery is amazing, and I believe that fears of incisions, scaring, complications and long painful recovery times are now concerns of the past with this new technology,” she says.
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/
The special focus of the June 2011 Focused Ultrasound Surgery Foundation newsletteris reimbursement from health insurers, an important factor in ensuring the widespread adoption of MR-guided focused ultrasound therapies. First up is an interview with German radiologist Matthais Matzko, MD. He has not only created the most successful and busiest focused ultrasound center in Europe, but also convinced leading insurers to provide reimbursement for the uterine fibroid treatments he performs.
On June 12, 2011, viewers of the CBS Evening News learned aboutStephanie Small’s gripping story. Suffering from a large uterine fibroid, the 27 year-old was treated last December as part of a MR-guided focused ultrasound clinical trial at the University of Virginia in Charlottesville.
Clinician interview: Matthias Matzko, MD, Amper Kliniken AG, Dachau, Germany
Matthias Matzko, MD has emerged as a leading European advocate for MR-guided focused ultrasound. In his native Germany, he has also played a key role in eliminating one of the most challenging barriers to widespread adoption of the promising medical technology: reimbursement.
Head of Interventional and Diagnostic Radiology at the 450-bed Amper Kliniken AG in Dachau, Matzko learned about focused ultrasound in 2008 from a colleague. He admits to becoming “kind of infected” with enthusiasm for the technology after visiting Wladyslaw Gedroyc, MD at St. Mary’s Hospital in London.
Matzko immediately recognized the potential of focused ultrasound and wanted to offer it at his hospital’s Myomzentrum, a center for the treatment of uterine myoma (fibroids), which had opened in June 2008. The center was already performing uterine artery embolization, myomectomy and hysterectomy.
“When I came back from London, I was very excited about the technology, and I was thinking about how to implement this in our environment,” he recalls. “Talking with the hospital administration, they were unsure about investing in the risk of a new method.”
De-risking equipment acquisition
So strong was his conviction, the business-savvy Matzko offered to rent a focused ultrasound system through an imaging company he heads and have it set up in the hospital. “I took the risk off the hospital administration,” he says. Arrangements were made through GE Financial to lease an ExAblate System from InSightec, Ltd.
At first, Matzko and his team performed focused ultrasound procedures only on Wednesdays and Saturdays, during time slots when the Myomzentrum’s MRI was made available to them. They performed five to ten treatments a month. As more patients learned about the availability and benefits of focused ultrasound, the center’s monthly treatment volume increased to 10-12 patients. “Our machine was fully booked in advance for about a four-month period of time,” Matzko explains.
Careful patient selection aids reimbursement
From the start, Matzko and his colleagues were convinced that careful patient selection was essential to achieving good results with focused ultrasound. Only a third of their uterine fibroid patients met the treatment criteria. “When you want to have reimbursement for such a new method, you have to produce good results, and that’s why you have to select patients very carefully,” he says.
With good results and patient satisfaction documented, Matzko and colleagues applied for reimbursement from Techniker Krankenkasse (TK), one of the largest insurance companies in Germany. Company representatives visited Amper Kliniken and focused ultrasound treatment sites in Berlin and Bochum.
Matzko says two factors were of greatest interest to the insurance company: 1) that only patients suited for focused ultrasound were treated with it; and 2) the Myomzentrum’s interdisciplinary team, which includes a gynecologist who provides both treatment and information to patients.
Although pleased with both the clinic’s results and services, the insurance company raised a red flag. The capacity to treat only three patients a week seemed too limited to qualify for reimbursement from a nationwide insurer.
Rather than a barrier, this objection became the basis of collaboration between the clinic, the insurance company and – ultimately – Amper Kliniken’s administration. Together, they planned the expansion of the existing focused ultrasound center. By this point, Matzko explains, “The hospital administration was convinced about the method of focused ultrasound and convinced about the business model.”
The expanded center opened in March 2010 with a fully dedicated MRI and ExAblate 2000. By then, the two largest German medical insurers were covering MR-guided focused ultrasound treatments. With all the pieces in place, the center’s monthly treatment volume quickly doubled.
The Dachau clinic continues to be on the leading edge of focused ultrasound technology. In November 2010, it became one of the first sites in the world to install the ExAblate One, the second generation system developed by GE Healthcare and InSightec. In the future, Matzko plans to expand treatment offerings to include new applications of the technology.
Marketing is another key to success
Matzko acknowledges that marketing was initially a challenge for the focused ultrasound center. “We started in a typical radiological manner,” he says. “We did marketing to referring physicians, and we informed all of our gynecologist colleagues in the south of Germany, in Switzerland, in Austria about our new center. The result was very poor.”
Recognizing that a strategy switch was in order, the center began marketing directly to patients via a new website and the use of Google ads. Increased patient requests for information led to the creation of a 24-hour hotline staffed by two patient managers knowledgeable about uterine fibroid treatment options. “Our aim is to figure out the ideal method to treat the personal situation of the patient,” Matzko explains.
In addition to Germany, Austria and Switzerland, the Dachau clinic is attracting patients throughout Eastern Europe and elsewhere. “They come from Poland, from Russia, from Bulgaria and even we had one patient coming in from Dubai,” Matzko notes. “We now have, in a small hospital like ours, an international customership.”
A story pitched and facilitated by the Focused Ultrasound Surgery Foundation was broadcast on the CBS Evening News on June 12, 2011.
Acknowledging that focused ultrasound could be one of the biggest medical advances since the scalpel, the report included interviews with uterine fibroid patient Stephanie Small and University of Virginia radiologist Alan Matsumoto, MD.
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. Click here to read full report.
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.
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.
Richard J. Price, Ph.D. is investigating a novel combination of nanoparticles, microbubbles and focused ultrasound – a combination that he believes could effectively treat and possibly cure diseases of the central nervous system, including brain tumors, dementia and Parkinson’s disease.
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.
Written by Ellen C., McKenna
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
On April 22, MIT’s Technology Reviewreported thata start up company,Perfusion Technologies, has designed a headset to deliver ultrasound waves throughout the brain, thus disrupting the normally impervious blood-brain barrier so cancer drugs can pass though. According to the report, the company claims its approach is simpler and cheaper than the MR-guided focal drug delivery methods being explored by other brain researchers.
Tracey Daniels of the FUS Foundation’s patient support organization, Fibroid Relief, reports that the April 27 Fibroid Relief event in Houston was a great success. She notes a few highlights:
The event marked the first time that Fibroid Relief worked in partnership with two focused ultrasound centers, each of which is using a different device to noninvasively treat uterine fibroids. The Methodist Hospital is performing treatments with the FDA-approved InSightec ExAblate System; St. Luke's is a clinical trial site for the Philips Sonalleve System.
The February/March 2011 issue of Albemarle Magazine featured an extensive interview with FUS Foundation Founder and Chairman Neal Kassell, M.D. In addition to chronicling the Foundation's origins, the report provides an excellent overview of the potential and promise of MR-guided focused ultrasound. Read report >
CHARLOTTESVILLE, VA (April 26, 2011) - The Focused Ultrasound Surgery Foundation has announced the dates and location for the 3rd International Symposium on Focused Ultrasound Therapy. The meeting will be held October 14-17, 2012 at the Bethesda North Marriott Hotel & Conference Center in Bethesda, MD, USA.
Targeted to scientists, clinicians and others interested in current and future applications of focused ultrasound, the 2012 symposium will spotlight research and clinical developments. The program will include plenary sessions, panel and small group discussions, poster presentations and technical exhibits.
From the launching of new initiatives in reimbursement and regulatory affairs to the 2nd International Symposium on MR-guided Focused Ultrasound, 2010 was a momentous year for the FUS Foundation. Research remained our key area of investment as indicated by the invitational workshops hosted by our Brain and Drug Delivery Programs and by our funding of Research Awards and Fellowships. Electronic version of our 2010 Annual Report >
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.
Governor Robert McDonnell of Virginia visited the Focused Ultrasound Center at the University of Virginia yesterday. Dedicated in September 2009, the center is the first to receive the Focused Ultrasound Surgery Foundation’s “Center of Excellence” designation and is a hub for performing multidisciplinary preclinical and clinical research, training and patient treatments at the highest level.
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.
Tina Krall, executive director of Fibroid Relief, the FUS Foundation's inaugural patient support organization, was a guest today on "Real Women on Health," a radio program hosted by Kelley Connors. Real Women on Health is an online community and radio show for women who want to be their own health and wellness advocates. Joining Krall on the program were John Fischer, M.D. of St. Luke’s Episcopal Hospital in Houston and Wendy Perkins, a patient advocate who opted to treat her uterine fibroids with MR-guided focused ultrasound. Krall and Fischer will also appear at the Fibroid Relief at Last Event scheduled for April 27 in Houston.
According to Krall, today's program featured a discussion of various treatment options for uterine fibroids and provided "a lot of great coverage for focused ultrasound." Here is a link to a recording of the show: http://blogtalk.vo.llnwd.net/o23/show/1/771/show_1771371.mp3
During last month's meeting of the European Congress of Radiology in Vienna, Philips Healthcare announced that its Sonalleve MR-HIFU system has received CE Marking for palliative care of patients with bone metastases. Equivalent to FDA approval in the U.S., CE Marking is recognized by countries in the European Economic Area and signifies that a product complies with the essential requirements of relevant health, safety and environmental protection legislation.
The company acknowledged that it intends to seek similar approval in the U.S.
Philips has been marketing the Sonalleve for uterine fibroid treatment since December 2009 and has installed 22 systems worldwide. The Sonalleve system uses ultrasound energy to ablate metastatic tissue and sensitive nerves around the bone, alleviating the significant pain experienced by advanced cancer patients. The system's MR imaging provides 3D planning and temperature monitoring.
The April issue of the FUS Foundation's e-newsletter features an excluvie video interview with Billy R. Williams, a patient with essential tremor who experienced dramatically positive results after being treated with MR-guided focused ultrasound. Williams is the first patient treated in a first in the world clinical trial funded by the FUS Foundation. Read more and view video.
The FUS Foundation's patient support organization, Fibroid Relief, has scheduled a free public education event for April 27, 2011 in Houston, Texas. The event is being organized in partnership with the focused ultrasound centers at the Methodist Hospital and at St. Luke's Episcopal Hospital.
"This is the first time that we have organized an event to support two focused ultrasound centers," said Tina Krall, Fibroid Relief executive director. "Each center uses a different device to noninvasively treat uterine fibroids. Methodist is using the FDA-approved InSightec ExAblate System, and St. Luke's is a clinical trial site for the Philips Sonalleve System."
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.”
In a major development, Celsion Corporation and Philips Healthcare have requested FDA permission to launch U.S. clinical studies of a new focal drug delivery treatment for metastatic bone cancer. The method uses Celsion’s ThermoDox – a heat-sensitive liposomal encapsulation of the proven and widely used cancer drug, doxorubicin – and Philips’ MR-guided focused ultrasound technology.
Celsion is developing the combination of ThermoDox and high intensity focused ultrasound (HIFU) through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics.
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.
A front page story in the March 11, 2011 edition of the Richmond Times Dispatch featured an interview with Billy R. Williams, the first patient in a new clinical trial funded by the Focused Ultrasound Surgery Foundation. The first in the world clinical trial is asessing the safety and effectiveness of MR-guided focused ultrasound in treating essential tremor, a progressively debilitating condition that causes uncontrollable trembling in the hands and other areas of the body. Also interviewed was W. Jeffrey Elias, M.D., the University of Virginia neurosurgeon who performed the procedure and is the study's principal investigator.
In the report, Williams is quoted as saying, "I feel very good." He also explained, "I wanted these tremors taken care of so badly I really had no fear of having it done." Click below to read the full story.
A promising new, noninvasive treatment for patients with essential tremor is making headlines this week. As announced yesterday in a Focused Ultrasound Surgery Foundation press release, a clinical trial at the University of Virginia has successfully used MR-guided focused ultrasound to treat its first patient - a man who had been unable to use his dominant right hand for more than a decade due to essential tremor. The focused ultrasound procedure completely stopped the man's tremor, and doctors are hopeful that it will not return. The treatment involved no anesthesia, incisions or ionizing radiation and targeted the thalamus, an area deep within the brain that has been associated with movement disorders.
The Focused Ultrasound Surgery Foundation is funding the UVA trial, which is being conducted under an FDA-aproved protocol and could treat as many as 15 patients. The Foundation is also funding a parallel clinical trial at Sunnybrook Health Sciences Centre in Toronto, which is scheduled to begin later in 2011 under a Health Canada-approved protocol. Click hereto read the Foundation's press release.
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.
Graham Sommer, M.D., professor of radiology at Stanford University Medical Center, is opening up a new frontier in men's health for MR-guided focused ultrasound treatments. He and his colleagues at Stanford and the University of California, San Francisco have developed a device that uses this innovative, noninvasive technology to treat benign prostatic hyperplasia, or BPH. Click here to view video interview and read full report.
Kobi Vortman, Ph.D., CEO of InSightec, reports that two new sites have joined the company's Phase 1 clinical trial assessing the ExAblate Prostate System and 14 patients with low-risk prostate cancer have now received treatment.
The newly added sites are the University of Rome in La Sapienza, Italy and Jaslok Hospital in Mumbai, India. The other participating sites are the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia and the National Cancer Centre at the Singapore General Hospital in Singapore. Click here to view video interview and read full report.
As many as 30 patients with early stage prostate cancer could be treated with a new, minimally-invasive device in a clinical trial expected to begin at two U.S. hospitals later this year, says Paul Chipperton, CEO of Profound Medical, Inc. (PMI).
The trial will evaluate the safety and effectiveness of the company's innovative MR-guided thermal ultrasound device, which Chipperton says has the potential to treat patients three to six times faster with greater accuracy and fewer side effects than existing options. Click here to view video and read full report.
Just released, the Foundation's February 2011 online newsletter features a special update, "Men's health and MR-guided focused ultrasound."Through video interviews and accompanying articles, the update spotlights new treatments for two conditions that afflict millions of men worldwide – prostate cancer and benign prostatic hyperplasia (BPH).
Click hereto access the newsletter.
The FUS Foundation Board of Directors has elected a new member, Frederic H. Moll, M.D., a serial entrepreneur whose start-up ventures have includedIntuitive Surgical, Inc., manufacturer of one of today's most successful and innovative medical devices, the da Vinci Surgical System.
Vendor Update: InSightec, Ltd., Israel
InSightec reports that two new sites have joined its Phase 1 clinical trial assessing the ExAblate Prostate System and 14 patients with low-risk prostate cancer have now received treatment.
The newly added sites are the University of Rome in La Sapienza, Italy; and Jaslok Hospital in Mumbai, India. The other participating sites are the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia and the National Cancer Centre at the Singapore General Hospital, Singapore.
Vendor update: Profound Medical, Inc., Canada
As many as 30 patients with early stage prostate cancer could be treated with a new, minimally-invasive device in a clinical trial expected to begin at two U.S. hospitals later this year, says Paul Chipperton, CEO of Profound Medical, Inc. (PMI). The Toronto-based venture is commercializing intellectual property and technology licensed from Sunnybrook Health Sciences Centre.
Site Update: Laurence Klotz, M.D, Sunnybrook Health Sciences Centre, Canada
Laurence Klotz, M.D., a urologic oncologist at the University of Toronto’s Sunnybrook Health Sciences Centre, says planning is underway for a second clinical trial using an investigational transurethral ultrasound device developed at Sunnybrook to ablate prostate cancer.
CHARLOTTESVILLE, VA (February 15, 2011) – The Board of Directors of the Focused Ultrasound Surgery Foundation has announced the election of Frederic H. Moll, M.D., a serial entrepreneur whose start-up ventures have included Intuitive Surgical, Inc., manufacturer of one of today’s most successful and innovative medical devices, the da Vinci Surgical System.
Clinical trials using MR-guided focused ultrasound to treat uterine fibroids and pain from cancer that has metastasized to bones are enrolling patients at the University of Virginia Health System. Details of those studies are reported in the latest issue of the UVA edition of Physician’s Practice Magazine.Click below to view the full report.
UVA Physicians Practice Magazine Article
The January 24 issue of Aunt Minnie.com Ultrasound Insideroffers a link to a story about a MR-guided focused ultrasound system designed specifically for breast tumor ablation. Under development at the University of Utah School of Medicine in Salt Lake City, the system was the topic of a presentation given by Allison Payne, PhD, at the FUS Foundation’s 2nd International Symposium on MR-guided Focused Ultrasound in October 2010. Click hereto read the report, which was published by MedicalPhysicsWeb.com.
A training program that seeks to expedite the development of targeted cancer therapies using nanoporation and MR-guided focused ultrasound has been scheduled for March 27 through April 1, 2011 in Haifa, Israel.
Fibroid Relief, the Foundation’s Patient Initiative, is gearing up for a successful Fibroid Relief At Last event in Charlottesville scheduled for next Thursday, February 3 at the historic Jefferson Theater on the Downtown Mall. Dr. Joann Pinkerton, highly regarded Medical Director of UVA’s Midlife Health Center, was just added to the impressive panel of experts slated for the event. Dr. Pinkerton is a leading expert in perimenopause and menopause and is frequently invited to speak throughout the country on abnormal uterine bleeding.
For additional information on the event, visit www.fibroidrelief.org.
Partnering for Cures Conference Provides Collaboration Opportunities for Those Pursuing Effective Therapies for Patients Faster
FasterCures, the Washington, DC-based center of the Milken Institute, convened the second annual Partnering for Cures, December 14-15, 2010 to advance the goal of bringing effective therapies to patients faster. Partnering for Cures brought together all the sectors engaged in the research enterprise to facilitate the strategic collaborations needed to turn scientific discoveries into accessible therapies.
For the second year, a representative of the Focused Ultrasound Surgery Foundation attended this dynamic meeting. More than 800 people were in attendance, representing innovators, investors, non-profit leaders, government agencies and decision- makers. It was a wonderful opportunity to share MRgFUS with a group so dedicated to accelerating medical solutions for deadly and debilitating diseases. While an enormous amount of progress is being made in finding effective MRgFUS therapies for cancer, Essential Tremor, Parkinson’s disease and a variety of other conditions, many leaders dedicated to finding cures for these same diseases are unaware of the promise MRgFUS has in providing positive outcomes. They are eager and ready to learn. Of course, there was much discussion about how the FDA and NIH can and is changing to quicken the advancement and delivery of new therapies and treatments. The quality of the speaker and relevance of the topics discussed speak volumes. To read more, visit the symposium website at http://fastercures.org/index.cfm/OurPrograms/Partnering_for_Cures.
The FUS Foundation's patient-support organization, Fibroid Relief, is kicking off 2011 with a free educational event in Charlottesville, Virginia on February 3. The event will be the first held in conjunction with the Focused Ultrasound Center of Excellence at the University of Virginia.
According to Tina Krall, executive director of Fibroid Relief, confirmed speakers include Alan Matsumoto, M.D. (Focused Ultrasound and Uterine Fibroid Embolization); Elisa Trowbridge, M.D. (Robotic Myomectomy); Bruce Bateman, M.D. (Gynecology and Fertility); Annette Owens, M.D. (Sexual Health); Cindy Janechild, R.N. (Holistic Medicine) and three uterine fibroid patients, one of whom was successfully treated with MR-guided focused ultrasound at UVA.
The FUS Foundation is one of the sponsors of the 4th Therapeutic Ultrasound School being held in Les Houches, France. Successor to the hugely successful schools in Oxford and Corsica, the program will explore the rapidly emerging field of therapeutic ultrasound. Topics will range from an introduction to the physics and biophysics necessary for understanding these techniques to clinical applications. Each topic will be covered by an invited speaker who is a world authority in the field.
For more information, visit the information page or download the flyer. Spaces are limited, so register early!
Last August, the Foundation newsletter reported that the University of California San Francisco had received a $1,368,750 grant from the National Institutes of Health to install a MR-guided focused ultrasound system.
Principal investigator for the project - Fergus Coakley, M.D., Professor of Radiology, Abdominal Imaging Section Chief, and Vice Chair of Clinical Service - said that the equipment would be used to explore new applications of MR-guided focused ultrasound such as treatments for painful bone metastases and prostate cancer. "We're looking to push the envelope and do what we can to advance this exciting field," he said.
Last month, John Snell, Ph.D. (Technical Director of the FUS Foundation Brain Program) and I visited Sunnybrook Research Institute (SRI) in Toronto, ON. We had the pleasure of touring the incredible facilities there.
Kullervo Hynynen, Ph.D., Director of the Imaging Centre, showed us around the research space that houses the labs of nearly 20 faculty members doing imaging research. This space includes dedicated clinical, pre-clinical and laboratory areas for research in focused ultrasound. In addition, the Centre has manufacturing capabilities for transducer design and development. Thus, its staff can build solutions in-house and test them through the full translational process from design through pre-clinical and clinical testing.
The hardest part of his job, says Joo Ha Hwang, M.D., Ph.D., is informing patients that they have pancreatic cancer.
Hwang, a leading researcher in focused ultrasound and gastroenterologist at the University of Washington in Seattle, is troubled by the lack of effective treatments for this deadly disease. "For decades, we've been treating pancreatic cancer and coming up with one new drug regimen after another. Yet, nothing has made a dent in improving patient survival," he notes.
Preclinical studies using MR-guided focused ultrasound for targeted drug delivery have achieved promising results, and Hwang believes clinical trials could begin within the next two years. "The potential impact of focused ultrasound could be huge," he says. "It could completely change the paradigm for treating patients with pancreatic cancer."
Read more and view video>
Advancing a game-changing technology like MR-guided focused ultrasound from research bench to clinical reality requires the contribution of many stakeholders. One such group – first-to-be-treated patients – often goes unsung.
The January issue of the FUS Foundation newsletter provides an engaging profile of Doris McArdle, an indomitable 89-year-old who and recipient of the first MR-guided focused ultrasound treatment for a benign pancreatic tumor. Performed on a compassionate care basis at St. Mary’s Hospital in London, England, the treatment ablated about a fourth of Mrs. McArdle’s sizable tumor and has relieved about 75 percent of her persistent pain.
Click hereto read the complete details of Mrs. McArdles's treatment and recovery.
Since installing an ExAblate 2100 system in May 2010, Alessandro Napoli, M.D., Ph.D.and his colleagues at Sapienza University of Rome have wasted no time in making their mark on the field of MR-guided focused ultrasound.
InSightec, a leading producer of MR-guided focused ultrasound equipment, has posted a special report summarizing the FUS Foundation's highly successful 2nd International Symposium. InSightec was among the corporate sponsors that supported the symposium, which was held October 17-20, 2010 in Chantilly, Virginia, USA.
Click here to download the summary.
UCLA Radiology has announced that Dr. Nelly Tan in Abdominal Imaging is awarded $100,000 from FUS Foundation to support her roles in advancing MRgFUS at UCLA. Click here to read full report.
The FUS Foundation's first newsletter of 2011 has been posted. This month's issue spotlights exciting developments in an area of great potential for MR-guided focused ultrasound - pancreatic tumor treatment.
As you will read, clinicians in Europe recently treated patients with focused ultrasound to relieve pain associated with pancreatic tumors.
Keyvan Farahani, Ph.D., of the Cancer Imaging Program at the National Cancer Institute (NCI) reports that funding is available through four research initiatives in image-guided cancer interventions. For further information email Dr. Farahani at
"What a difference a year makes!" exclaimed Doris McArdle and her daughter, Sharon Duffy, in a recent New Year’s greeting.
The recipients of that message – David Heller, Neal Kassell, M.D. and Wladyslaw Gedroyc, M.D. – made a difference that McArdle will never forget. In November 2010, the indomitable, 89-year-old McArdle boarded a trans-Atlantic flight from Chicago to London. There, she successfully underwent a noninvasive MR-guided focused ultrasound procedure to relieve acute pain and discomfort caused by a large benign tumor in her pancreas.
The hardest part of his job, says Joo Ha Hwang, M.D., Ph.D., is informing patients that they have pancreatic cancer.
Hwang, a leading researcher in focused ultrasound and gastroenterologist at the University of Washington in Seattle, is troubled by the lack of effective treatments for this deadly disease. “For decades, we’ve been treating pancreatic cancer and coming up with one new drug regimen after another. Yet, nothing has made a dent in improving patient survival," he notes.
Developing new treatments for brain disorders poses many challenges for focused ultrasound researchers. While the blood brain barrier is a key obstacle for those developing drug delivery therapies, the skull poses significant difficulties for researchers designing sound-based treatments.
In a Foundation-sponsored project, Thilo Hoelscher, M.D., a neurologist and professor of Neuroscience and Radiology at the University of California, San Diego, is developing a database that will help clinicians individualize the intensity of sound waves for different types of skulls.
For the past decade, Richard J. Price, Ph.D., a biomedical engineer and associate professor at the University of Virginia, has conducted pioneering research in ultrasound targeted therapeutics. His international reputation and accomplishments make him an ideal fit for his new job as Research Director at the UVA’s Focused Ultrasound Center.
While much of Price’s research has focused on nanoparticles and microbubbles, he is also a widely recognized authority on the mechanisms of cardiovascular blood vessel growth. Currently, he divides his time between both research interests.
When working in a field as expansive and exciting as Focused Ultrasound-mediated Targeted Drug Delivery, it's sometimes easy to lose sight of all the other compelling areas of Image Guided Drug Delivery (IGDD) that are equally promising on the path to better cancer care. The presentations at the "Hot Topics" Session on IGDD at on November 30th, 2010 at the Radiological Society of North America (RSNA) Meeting were a small but solid glimpse into technologies that - along with FUS-TDD - hold great promise for improved efficacy and patient outcomes.
During the recent Radiological Society of North America (RSNA) Meeting, the "Hot Topics" Session on HIFU boasted well over 100 attendees despite the early Monday morning time-slot on November 29th, 2010.
Presenters covered MR-guided focused ultrasound for the treatment of breast cancer, pain palliation of bone metastasis, and uterine fibroids.
As the objective of the session was to provide an overview of the technology and clinical applications currently in practice or on the horizon, no new data was presented from the 2nd International Symposium on MR-guided Focused Ultrasound. Yet for those unfamilar with the technology, the presentations provided a thorough introduction and overview - which we very much hope served as the beginning of attendees' exposure and interest in the field.
Here is a video piece recently done by WUSA Channel 9 in Washington DC featuring focused ultrasound, InSightec, Philips, and our recent Symposium.
The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) are co-sponsoring a free conference on Methodological Challenges in Comparative Effectiveness Research.
“Comparative effectiveness research (CER) is increasingly important to the advancement of MR-guided focused ultrasound,” says Joy Polefrone, Ph.D., director of the Foundation’s FUS-Targeted Drug Delivery initiative. CER compares existing treatment options to determine which is most effective in different types of patients and circumstances.
“Treatments for uterine fibroids – the first FDA-approved indication for MR-guided focused ultrasound – are already being addressed by an AHRQ stakeholder group. The group has developed protocol recommendations to address concerns about these treatments,” Polefrone notes. “Future applications of MR-guided focused ultrasound will undergo CER assessment in the U.S., making it important to understand this process and its impact on clinical use.”
Scheduled for December 2-3, the conference will be held at the NIH Clinical Center in Bethesda, Maryland. It will address a variety of important questions about comparative effectiveness research that face U.S. researchers, care providers, health systems, and patients. In particular, the conference will explore a number of case studies challenging the kinds of research, methods and analyses that should be used to address limitations in current evidence for interventions and tests being examined by decision-making bodies
In addition to these case-based discussions, consumers, economists, methodologists, policymakers and statisticians will present two additional sessions:
The conference is free and requires advance registration.To register and for more information, visit: http://conferences.thehillgroup.com/CERDecemberConference/about.html
1. High-Intensity Focused Ultrasound: Myth or Reality?(Monday, November 29, 7:15-8:15 a.m.)
Eva Bouwsma, M.D.,Mayo Clinic, Department of Reproductive Endocrinology, Rochester, MN, USA“Clinical Predictors of Magnetic Resonance-guided Focused Ultrasound Surgery”Caitlin Burke,University of Virginia, Biomedical Engineering, Charlottesville, VA, USA“Composite Drug-Delivery Agents Comprised of 5FU-Bearing Controlled-Release Nanoparticles Bonded to Microbubbles Inhibit Glioma Growth Upon Activation with Ultrasound”
Navid Farr,University of Washington, Department of Bioengineering, Seattle, WA, USA“Small Animal Adaptor Setup and Protocols for Magnetic Resonance-guided Focused Ultrasound”Ronit Machtinger, M.D.,Brigham and Women's Hospital/Harvard Medical School, Department of Obstetrics and Gynecology, Boston, MA, USA“Analyzing Screen Failures Prior to MRgFUS for Uterine Fibroids: Do African American (AA) Women Have Different Characteristics?”
"Honestly this is one of the most amazing meetings I've attended" states Christopher Cheng, Singapore General Hospital. "There are a lot of networks being set up...You can hear accents from France, Europe, North America, Asia and people bring the diversities of their cultural and different backgrounds to the meeting. This is a prime example of how it should be done."
Suzanne LeBlang, M.D. of University MRI in Boca Raton, FL commented, "It's amazing to see how the field has grown and how many young investigators are now getting interested in MR-guided focused ultrasound to bring it to the next level."
"The poster session in particular had really good attendance and a lot of interest from participants, which really helps people early in their career like myself," noted Allison Payne, Ph.D., a Young Investigator Award recipient from the University of Utah
Thilo Hoelscher, M.D., of the University of California, San Diego, shared some of this thoughts on the 2nd International Symposium on MR-guided Focused Ultrasound. Hoelscher noted, “Meetings like this are the meetings we need to change ideas and discuss with colleagues how we should approach different applications.”
Lawrence Crum, Ph.D., of the University of Washington shares some of this thoughts on the 2nd Internaltional Symposium on MR-guided Focused Ultrasound. According to Dr. Crum the Symposium offered a "tremendous array of professionals, clinicians, in a technology that's going to change the way we do medicine in the United States."
Symposium attendees involved in MR-guided focused ultrasound treatments for uterine fibroids will have an opportunity to participate in an important Mayo Clinic study.
On the eve of its 37th anniversary, Jaslok Hospital and Research Centre in Mumbai announced in early July that it was launching the era of non-invasive surgery in India by opening the country’s first MR-guided focused ultrasound facility.
Dr. Shrinivas Desai, the hospital’s Director of Imaging and Interventional Radiology, noted the pioneering nature of the center.
Scientists and clinicians who are researching uses of MR-guided focused ultrasound are encouraged to submit abstracts for the upcoming 2nd International Symposium on MR-guided Focused Ultrasound. The deadline for abstract submissions is Monday, August 16.
Scheduled for October 17-20 in the Washington, D.C. area, this landmark event will spotlight leading edge preclinical, translational and clinical research related to one of today’s most promising and innovative therapeutic technologies. The symposium will offer a multifaceted exploration of this emerging field and feature plenary sessions, panel discussions, poster presentations and technical exhibits.
During its quarterly meeting on August 4, the Foundation's Board of Directors elected Andrew von Eschenbach, M.D. to a three-year term. As Foundation Chairman Neal Kassell, M.D. commented, “We are honored to welcome Dr. von Eschenbach to our board. His long-standing commitment to serving the public good by accelerating the availability of innovative medical treatments is well matched to the mission and goals of this organization. We look forward to benefitting from his vast experience, transformative perspective and eminent leadership.”
The Foundation’s Focused Ultrasound-mediated Targeted Drug Delivery Program (FUS-TDD) has announced the formation of a Core Stakeholders Group that includes many of today’s leading researchers and experts:
The Foundation’s patient support organization, Fibroid Relief, will conduct its second Coffee and Conversation event in London on Saturday, July 31.
Presented in partnership with St. Mary’s Hospital, the event will offer an intimate, safe and supportive environment where past and present uterine fibroid sufferers can talk freely about their experiences, share knowledge and learn from each other.
Funded project will develop temperature measuring techniques for treating breast and liver cancer withMR-guided focused ultrasound
Nick Todd, Ph.D., and his colleagues at the University of Utah in Salt Lake City and the University of Geneva in Switzerland thrive on tackling difficult technical problems. Currently, they are developing MR temperature measuring techniques with the aim of overcoming the unique challenges of imaging the breast. Ultimately, their goal is to develop new, site-specific MR-guided focused ultrasound treatments for breast and liver cancer.
Researchers are using new generation of MR-guided focused ultrasound equipment to treat patients with uterine fibroids and pain from metastatic bone tumors.
Dedicated in September 2009, the Foundation-sponsored Focused Ultrasound Center of Excellence at the University of Virginia Health System in Charlottesville has taken the first steps in building a robust, multi-disciplinary clinical trial program.
CE Mark certification expanded to include adenomyosis
Until late last month, women suffering from adenomyosis – a benign gynecologic condition that causes heavy menstrual bleeding, pain and diffuse uterine enlargement – had two treatment options: have a hysterectomy and lose the ability to conceive; or, take medication for temporary symptom relief.
I recently participated in an FDA-sponsored satellite symposium related to Focused Ultrasound-mediated Targeted Drug Delivery (FUS-TDD). The symposium was the afternoon following the close of the 2010 Accelerating Anticancer Agent Development and Validation Workshop, a 3-day post-graduate workshop for clinical and translational investigators interested in designing effective strategies to develop new anticancer agents.
Excitement is building for the 2nd International Symposium on MR-guided Focused Ultrasound, which has just announced that its roster of speakers, moderators and discussion leaders will include many internationally-known thought leaders, clinicians and researchers. Please see below for details.
Late last week, Israeli blogger Mouli Cohen wrote about the use of MR-guided focused ultrasound to treat stroke (see his blog here).
Cohen wrote about the work being done by Thilo Hoelscher M.D. at the University of California at San Diego. Dr. Hoelscher is conducting FUS Foundation-funded research using InSightec's high-intensity focused ultrasound (HIFU) system, the ExAblate.
Professor Daniel Jeanmonod faced a packed meeting room at the Philadelphia convention Center on May 3 when he presented his much-anticipated results treating 12 patients in Zürich using transcranial MR-guided focused ultrasound (TcFUS). Many neurosurgeons in the audience at the Stereotactic and Functional Neurosurgery Session of the 2010 annual meeting of the American Association of Neurological Surgeons were there mainly for his presentation.
He reported on 18 ablative lesions performed in 12 patients using transcranial central lateral thalamotomy with the Exablate 4000 (Insightec Ltd, Haifa). All patients suffered from chronic therapy-resistant neuropathic pain, including some who had failed prior radiofrequency lesioning. Real-time MR image monitoring (thermometry) was performed in awake patients, allowing for on-line control of targeting parameters, precision and safety.
His work confirmed the high level of precision in lesion placement (< 1.0 mm) that had been previously reported (Martin E. et al., Annals of Neurology 66(6):858-861, 2009). Skull heating was minimal.
Peri-lesional edema appeared on MRI within 48 hours, but was resolved at the time of the 1-month MRI.
The Foundation congratulates Toronto-based Profound Medical, Inc., winner of the prestigious, 2010 Ontario Premier’s Catalyst Award for “Start-up Company with the Best Innovation.” The Ontario government will also invest C$ 200,000 in further developing the company’s investigational MR-guided focused ultrasound device for treating prostate cancer.
The company is in the midst of securing financing to accelerate clinical trials in North America, Canada and the European Union.
Recently I attended the American Association of Cancer Research Conference (AACR) in Washington, DC and the topic of personalized medicine permeated the conference. It began with the results of the BATTLE Trial (Biomarker-integrated Approaches of Targeted Therapy for Lung cancer Elimination) during the Opening Plenary Session. The BATTLE Trial is a unique Lung Cancer Trial that was the first of its kind in two ways. First, the trial design was adaptive in that the treatment plan for patients was modified during the trial. Secondly, the trial required that a fresh core needle biopsy from each patient be obtained at diagnosis.
The acquisition of a tumor sample from a patient AND the use of tumor sample’s biomarker presentation to drive the patients’ treatment based on the biomarkers presented on their particular tumor was, well…personalized medicine. And it worked. Both the adaptive approach and the targeting of drugs to specific biomarkers resulted in improved outcomes for patients in a disease that is notably difficult to treat.
I couldn’t help but extrapolate this study to the potential of Focused Ultrasound-mediated Targeted Drug Delivery. FUS-TDD treatments will transport highly concentrated drug payloads directly to a tumor site while providing near-immediate delivery confirmation.The BATTLE study plus the conference sessions on Nanotechnology in Cancer and on Image Guided Drug Delivery fueled my own excitement about the promise that FUS-TDD holds for the future of cancer therapy and personalized medicine.
Executive Perspective: Falko Busse, PhD, Philips Healthcare
Asian markets are leading the adoption of focused ultrasound, reports Falko Busse, PhD, vice president and general manager of MR-HIFU for Philips Healthcare.
To encourage school girls to pursue careers in science and technology, Germany celebrated its tenth annual Girl’s Day on April 21, and one of the newest developments featured was a MR-guided focused ultrasound system, Insightec’s ExAblate 2000.
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