As reported in this issue, major developments in the field of focused ultrasound were spotlighted at recent meetings in the US and Europe. We congratulate the many clinicians and researchers who contributed to these accomplishments and also offer special acknowledgement to another group essential to the advancement of focused ultrasound therapies – the courageous and generous patients who volunteer for clinical trials.
The unsung heroes of medical progress, clinical trial participants, often undertake immense personal risks to help chart new therapeutic territory. As we recently learned from Essential Tremor study patient John Watterson and his wife, Yvonne – who are interviewed in this issue – the decision to volunteer for an investigational procedure can evoke much fear and trepidation among family members. For those who have successful outcomes, like Watterson, risk-taking pays off in the form of physical improvements and a lightness of spirit among those who love them.
To all, we express our deepest thanks.
Preliminary results show focused ultrasound holds promise as a safe and effective treatment for essential tremor
Dr. Elias and his team during ET procedure
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 2011 meeting of the Congress of Neurological Surgeons 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.
"So far, this noninvasive treatment has been life-changing for patients,"said Elias, who is Director of Stereotactic and Functional Neurosurgery at UVA. "All now have improved ability to use their dominant hand to perform tasks that they couldn't do before treatment, such as writing legibly, drinking and eating without spilling, and buttoning clothes. It has been exciting to see their immediate improvements."
The study is using magnetic resonance imaging to guide and monitor the delivery of focused ultrasound to tremor-causing nerve cells in the thalamus, a region deep within the brain known to be an effective target for ET and other movement disorders. The treatment goal is to reduce tremor in a patient's dominant hand.
Recently, FUSF Director of Development Kimberly Skelly was delighted to receive the following unsolicited letter:
Dear Ms. Skelly, I was the fifth person to undergo focused ultrasound treatment for Essential Tremor. Dr. Elias performed the surgery on June 20, and, so far, my tremor is much improved.
I'm also Executive Director of The Watterson Foundation, a small family foundation, which consists of my two brothers and myself. We normally give to organizations that assist youth, seniors, the homeless, and people who somehow fall through the cracks.
Because of my surgery, I wanted to make a small donation to your foundation and, hopefully, we can do more later in the year.
I am extremely grateful to the Ultrasound [Surgery] Foundation for making possible this surgery, which has helped me immensely. And, I can't begin to say enough good things about the work of Dr. Elias and his staff – so I won't even try.
Sincerely, John S. Watterson Vice-President and Executive Director The Watterson Foundation Charlottesville, VA
Later, Watterson visited Foundation headquarters and invited us to attend an event he was hosting. The goal of the event was to educate the local essential tremor community about focused ultrasound and the clinical trial at the University of Virginia.
At the conclusion of that event, we had an opportunity to interview both Watterson and his wife, Yvonne, who lovingly refers to her husband as "Patient Number Five." In the interview, Watterson described his pre-treatment symptoms, focused ultrasound treatment, and outcome; Yvonne discussed how her husband's participation in the essential tremor study caused her to feel fear, concern and – ultimately – delight.
Vendor update: Philips launches new Sonalleve platform at CIRSE
By Neil Glossop, FUS Foundation Consultant
Sonalleve platform was introduced at CIRSE by Philips Healthcare
Held in Munich, Germany from September 10 to 14, the 2011 meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) brought together researchers and clinicians in interventional applications from all over the world. The strength and commitment of this community was signified by the number of delegates in attendance – 6,164, a new record – and the number of abstracts submitted – 1,413.
A key event related to focused ultrasound was the Philips Healthcare users meeting and the official launch of the company's new Sonalleve platform. The updated system fully integrates Ingenia, the new digital broadband MR system recently introduced by Philips. The data acquisition and imaging capabilities of the Ingenia are so advanced that they can be compared to the transition from analog box televisions to the new generation of digital flat screen platforms.
Meeting Report: Focused Ultrasound Symposium in Rome
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 several of our funded researchers as well.
From my perspective, key takeaways from the meeting included:
MR-guided focused ultrasound research and development is robust in Europe and is receiving a tremendous amount of government funding, especially in the Netherlands and the United Kingdom.
The field of ultrasound-guided focused ultrasound has advanced solidly and is now being used to treat prostate, thyroid and liver cancer and for pain palliation as well.
Multi-disciplinary, multi-institutional, public-private collaboration is of great interest – an initial discussion was held to develop a European Working Group to facilitate the adoption of both MR-guided and ultrasound-guided applications.
The European community holds the FUS Foundation in high regard and has asked us to facilitate the formation of its new Working Group. Further details are now being planned and will be announced in coming months.
Site update: Sapienza University emerging as a driving force for FUS in Europe
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.
Further boosting its strong start, early this year, Sapienza announced plans to organize the 1st European Symposium on Focused Ultrasound Therapy. A highly successful event, the symposium occurred last month with 200 attendees from Europe, Asia and the North America.
Alessandro Napoli, MD, PhD
FUS as first-line therapy for bone metastasis In a symposium presentation, Alessandro Napoli, MD, PhD of Sapienza's Department of Radiological Sciences, described yet another precedent-setting success for the center: a clinical trial using MR-guided focused ultrasound as a first-line therapy for bone metastasis. In the study, target lesions have not been treated with radiation or other therapies; just focused ultrasound is being used.
FUS Foundation presentations at Rome symposium now posted on our website
FUS Foundation team members, Neal Kassell, MD, Joy Polefrone, PhD and Heather Huff-Simonin, MBA were among the featured speakers at last month's 1st European Symposium on Focused Ultrasound Therapy in Rome.
Since these talks provide a wealth of insightful information about the Foundation's work and the field of focused ultrasound, we are making them publically available. Please click the links below to view each presentation.
Research on Focused Ultrasound and Fertility Receives International Award
By Tracey Daniels, Fibroid Relief Outreach Associate
We are always pleased when research on non-invasive MR-guided focused ultrasound is published. It helps to make this new treatment more respected among physicians — and thus, potentially more available to patients.
What is even more exciting is when a focused ultrasound study is so highly regarded that it receives international recognition. This was recently the case with a fertility study conducted by Elizabeth Stewart, MD of the Mayo Clinic and member of our Fibroid Relief Advisory Board. Stewart's work was recently honored by the Royan Institute of Iran, which awarded her its International Research Award in the category of Female Infertility and Reproductive Imaging.
More important than the award, however, is what Stewart and her team learned from their research: that MR-guided FUS is a promising therapy for women who want to become pregnant after undergoing fibroid treatment. In the study – entitled "Safely Extending Focused Ultrasound Surgery for Uterine Leiomyomas to Women Who Desire Future Pregnancies"– the researchers found that the time to become pregnant following treatment was about the same as that for uterine artery embolization (UAE), a well-established, minimally invasive procedure that blocks the blood supply to fibroids. With MR-guided FUS, delivery rates were higher and cesarean section rates lower than with UAE.
Among the women in the study, 41 percent had a live birth following a focused ultrasound procedure and another 20 percent had an ongoing pregnancy beyond 20 weeks at the time of report. Sixty-four percent of the women were able to have a vaginal delivery. Importantly, there were no low birth weight infants and no pattern of complications for the baby or the mother.
The study itself, even without an international honor, represents a win for women. It provides further evidence that there are solid options out there for women with fibroids – especially those who don't want fibroids to rob them of the possibility of having a child.
FUS will be featured at Society for Neuro-Oncology Meeting
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, MD a 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."
In a new report, the Center for Devices and Radiological Health at the US Food and Drug Administration indicates it is fostering the development of "ultrasonic surgery," which uses high intensity focused ultrasound to perform surgery without incisions. The report, which is entitled, "Regulatory Science in FDA's Center for Devices and Radiological Health," provides a broad overview of the center's activities and its view of emerging regulatory science targets.
"Our efforts in regulatory science help foster a robust medical device industry by reducing the time and resources needed to develop and assess new products," the center's director, Jeffrey Shuren, MD, JD wrote in the report. "This promotes innovation, supports the manufacture of high quality products, and speeds the rate at which technologies reach the market."
Focused Ultrasound Surgery Foundation | 1230 Cedars Court, Suite F | Charlottesville VA | 22902 Questions and comments about this newsletter should be sent to the Foundation's Director of Communications, Ellen C. McKenna ()