We're delighted that many of our stories this month involve patient treatments, a true indication of the progress being made in improving and saving lives with MR-guided focused ultrasound. Three indications are spotlighted:
Uterine fibroids — Kevin Kim, MD and his colleagues at Johns Hopkins University in the US have become the first to publish three-year data that demonstrates the long-term patient benefits of MR-guided focused ultrasound. We also learned that two focused ultrasound sites — Rozdrav Federal State Treatment and Rehabilitation Centre in Russia and CHA Bundang Medical Center in Korea — have now treated more than 500 uterine fibroid patients and that a third — Amper Klinikan in Germany — is nearing that important milestone.
Essential tremor — The world's first essential tremor patient treated with MR-guided focused ultrasound, Billy R. Williams, and his neurosurgeon, W. Jeffrey Elias, MD, are featured in a syndicated video news report distributed to TV stations nationwide. The FUSF-funded study at the University of Virginia in the US has now treated ten patients and Elias is scheduled to report preliminary findings on October 2 at the 2011 Congress of Neurological Surgeons meeting in Washington, DC.
Prostate cancer — Twenty-three patients with organ confined low risk prostate cancer have been treated in a clinical trial being conducted at four sites — Sapienza University in Italy, the National Cancer Centre in Singapore, the NN Petrov Institute of Oncology in Russia and the Jaslok Hospital and Research Center in India. Study sponsor, InSightec, Ltd., reports that early results are promising.
We hope you enjoy reading these stories and all the other developments featured in this month's newsletter.
Johns Hopkins study finds MR-guided focused ultrasound offers long-term benefit to uterine fibroid patients
Researcher interview: Hyun S. (Kevin) Kim, Emory University, USA
Hyun S. (Kevin) Kim, MD
Being first on the market with new medical technology is a challenge-filled endeavor. Take, for example, the first MR-guided focused ultrasound system placed into clinical use, InSightec's ExAblate 2000. The device cleared a major hurdle in 2004 when it received approval from the U.S. Food and Drug Administration for the treatment of uterine fibroids.
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 evidence demonstrating long-term patient benefits.
While physician adoption and insurance coverage remain challenges, clinical researchers continue to generate favorable evidence, the most recent of which appears in the August 2011 issue of Academic Radiology. Hyun S. (Kevin) Kim, MD and his former colleagues at Johns Hopkins University (Baltimore, MD, USA) enrolled 40 uterine fibroid patients in their study of ExAblate outcomes and succeeded in tracking 29 of them for three-years, the longest follow-up period published to date.
"Results of this study provide information that people have been waiting for," explains Kim, who is now an associate professor of Radiology and Surgery at Emory University (Atlanta, GA, USA). "We have shown substantively and effectively that patient outcomes remain positive over the long-term."
Russian FUS center nearing 900-patient mark in treating uterine fibroids
In the July 2011 issue of this newsletter, we reported that CHA Bundang Medical Center in Seoul, South Korea had become the first MR-guided FUS site in the world to treat more than 500 uterine fibroid patients. An email from Paul Wragg, MSc (MRI) European Applications Manager for InSightec, Ltd., informed us that another site had already passed this clinical milestone.
According to Wragg, Rozdrav Federal State Treatment and Rehabilitation Centre in Moscow, Russia has treated 864 uterine fibroid patients. He expects the center will reach the 900-patient mark by the end of 2011 and break the 1,000-patient barrier in 2012.
"If a site should be regarded as exceptional, it is the Roszdrav Centre as they have treated more than 10 percent of the global total of ExAblate MRgFUS treatments on their own since starting their service in March 2006," Wragg wrote. "They actually reached the 500 treatment mark way back in August 2008."
In another email, Matthais Matzko, MD, of Amper Klinikan in Dachau, Germany, indicated that his FUS center is closing in on the 500-patient mark. Since opening in 2008, the center has treated 421 uterine fibroid patients.
Story about UVA essential tremor trial airing on TV stations around the US
TV viewers in dozens of American cities are learning about the FUSF-funded essential tremor trial at the University of Virginia. In early August, Ivanhoe Broadcast News — a syndication service that works in partnership with the American Institute of Physics — provided subscribing stations with a video report about the trial. Stations will air the story whenever newscast time permits.
The story features interviews with the study's first patient, Billy R. Williams, and its principal investigator, W. Jeffrey Elias, MD.
UVA trial update The UVA trial, which is still in progress, is the first in the world to evaluate the safety and initial efficacy of MR-guided focused ultrasound in treating essential tremor. Ten patients have been treated since the trial began in February 2011; five more will undergo the procedure before the study ends later this year. Primary investigator, W. Jeffrey Elias, MD, is scheduled to report preliminary findings on October 2 at the 2011 Congress of Neurological Surgeons meeting in Washington, DC.
InSightec provides update on its prostate cancer clinical trial
In a press release last month, InSightec, Ltd. reported that pilot clinical trials at four sites have used its MR-guided focused ultrasound system to treat 23 patients with organ confined low risk prostate cancer and that results are promising.
According to InSightec, five patients underwent near total gland ablation that preserved their urinary sphincter and neurovascular bundles, and 18 received focal treatments. None of the procedures (whole gland or focal) triggered Severe Adverse Events during or after treatment, and none required post-treatment intervention, demonstrating a good safety profile.
Company President and CEO Kobi Vortman, PhD said, "We are very encouraged by these early results that give hope that it may be possible in the future to offer prostate cancer patients a treatment option with a lower rate of complications compared to the currently available options."
Participating sites are Sapienza University of Rome in Italy, the National Cancer Centre in Singapore, the NN Petrov Institute of Oncology in St. Petersburg, Russia and the Jaslok Hospital and Research Center in Mumbai, India. InSightec expects to add more study sites in the near future.
Company that pioneered therapeutic ultrasound is collaborating with Siemens to develop an MR-guided treatment system
Vendor profile: Chongqing Haifu Technology Co. Ltd., Chongqing, China
Model JC from Chongging Haifu Technology Company
Chongqing Haifu Technology Company, Ltd. has been on the forefront of therapeutic ultrasound for more than a decade. Recognized for developing the world's first HIFU therapy system and the first clinical guidance for HIFU tumor therapy, the company was established in 1999 and has 300 employees. Its ultrasound-guided equipment has treated more than 60,000 patients at clinics in Mainland China, Hong Kong, South Korea, Japan, the United Kingdom, Italy, Spain, Russia, Romania, Ukraine and Saudi Arabia.
Today, Haifu is exploring new commercial opportunities, including a highly promising collaboration with Siemens Medical Solutions that is developing an MR-guided focused ultrasound system to treat uterine fibroids, osteosarcoma and other tumors.
FUSF Research Award applications reach record levels
The FUS Foundation's Research Awards Program received a record number of applications during the first half of 2011. By the end of the second quarter, the Foundation had received 15 proposals, eclipsing the whole-year totals of 11 and 14 for 2009 and 2010, respectively. "It's incredibly exciting news for the Foundation," says Hannah Edelen, Director of Research and Fellowship Programs.
Edelen attributes the rise to the Foundation's change from a rolling acceptance policy to a quarterly deadline system that encourages researchers to submit proposals sooner.
The number of applicants has increased steadily since the Research Awards Program's inception in 2007. This growth is important because the program, which generally provides awards of $100K for a one-year period, has filled a funding void for MR-guided focused ultrasound researchers by providing "seed money" for highly promising studies. Funding enables researchers to compile the preliminary data required for the more substantial grants — from government agencies and other sources — needed to move their work toward clinical reality.
Edelen believes that the upward trend in proposals is also an indication of the solid growth in the field of MR-guided focused ultrasound research. The increase in proposals also allows the Foundation to be more selective in the projects it chooses to fund, ultimately making a FUSF Research Award more prestigious for researchers as they seek future resources.
"There has been a clear explosion within the community in terms of the number of researchers doing work in this area. It's been remarkable to see how much the research has expanded in such a short period of time," she says.
The Research Awards Program passed the $2 million funding milestone in June. Though most proposals have come from the United States, researchers from Europe, the Middle East and Asia have also applied.
UVA Center of Excellence hosting 2nd anniversary symposium
The FUS Foundation's first-designated Focused Ultrasound Center of Excellence, which is located at the University of Virginia, will celebrate the second anniversary of its dedication by hosting a symposium from 5 to 9 p.m. on September 8, 2011.
"Our goals are to review the research and clinical accomplishments of the past year, foster collaborations among focused ultrasound-interested investigators, and generate new ideas for the future," explains the center's Research Director Richard J. Price, PhD. "Given the recent burst of activity in the UVA Focused Ultrasound Center, this should prove to be an exciting evening."
The symposium highlights will include:
Plenary talks by two leading focused ultrasound experts - Bradford Wood, MD and Matthew Dreher, PhD from the National Institutes of Health
Sessions on early translational and pre-clinical focused ultrasound studies at UVA, with emphasis on focal drug and gene delivery, nanomedicine, thermal ablation, and clot lysis
An "ideas" session featuring short talks from UVA investigators who are just getting started in focused ultrasound research
Updates on ongoing clinical trials/experiences for treating bone metastases, uterine fibroids and essential tremor
The symposium, which is open to researchers at UVA and beyond, is free of charge and will include dinner. To register, send an e-mail to Jamie DeVore (). Participants who wish to attend dinner must register by September 1, 2011.
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.
Symposium topics include: technology, brain, breast, bone tumors, liver, pancreas, prostate, uterine fibroids and targeted drug delivery.
The FUS Foundation is a sponsor of this important event, which is expected to draw physicians, physicists and scientists from many European sites. During the meeting, the Foundation will be represented by our Chairman and Founder Neal Kassell, MD, who is serving as co-president of the symposium, and by Joy Polefrone, PhD and Heather Huff Simonin, MBA who are on the faculty.
Polefrone's presentation is entitled, "Focal Drug Delivery Program Update: How a Collaborative Approach Aims to Accelerate the Development of Clinical Applications." Simonin will discuss, "The Global Adoption of MR-guided FUS." Both talks are scheduled for Friday, September 23.