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.

The GE/InSightec event featured guest presenters including Yoon, Alessandro Napoli, MD, of the University of Sapienza, Rome and Heather Huff- Simonin of the FUS Foundation. Jin-Suck Suh, MD, of Severance Hospital at Yonsei University served as session chairman.

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.

Fifteen years later, McDannold has established himself as one of the world’s leading focused ultrasound researchers. “What has kept me interested has been the promise of this technology to significantly help a large number of patients, the technical challenges involved, and the large number of applications that are possible with FUS,” he says. “The two main applications that I’m working on right now are using ultrasound instead of surgery to ablate tumors and targeted drug delivery.”

McDannold, who heads the Focused Ultrasound Laboratory in the Department of Radiology at Harvard Medical School, became the Focused Ultrasound Surgery Foundation’s first Research Award recipient in 2007. At the time, he was investigating how to ablate tumors in very deep brain structures without overheating the skull or damaging the brain and nerves around it.  His research goal was to make focused ultrasound lesions right next to the optic nerve while preserving its function.

Building on research performed by others, McDannold and his collaborator, Natalia Vykhodtseva, PhD, demonstrated that brain tissue could be ablated without any heat using low power focused ultrasound pulses to activate microbubbles injected into the circulation. “This really focuses the energy to the micro-bubbles themselves instead of the rest of the tissue,” McDannold explains. “We’re very happy about the results but we need to really look at this over a long period of time and make sure that we’re not causing any more subtle damage that’ll show up later.”

McDannold says the study is now complete and that a manuscript is under development. “We have submitted a proposal to the NIH to continue this project,” he adds.

2011 Research Award

Last month, McDannold received his second FUSF Research Award totaling $112,002, which will enable him to advance his work even further. His co-investigator is Margaret Livingstone, PhD, a professor in the Department of Neurobiology at Harvard Medical School. McDannold discusses that project and more in the interview below.

Q. What is your overall research goal, and how do your first and second FUSF research awards fit into this big picture?

McDannold:  We are trying to expand the areas in the brain that can be targeted by FUS. Brain tumors and other disorders are ideal targets for a noninvasive technique like FUS. Most of our laboratory's current research is dedicated to the use of FUS for ablation and targeted drug delivery in the brain. Both of the projects that have been funded by the FUSF are part of this goal. In the first, we hoped to find a way to target tumors or other structures near the skull base, where surgery can be extremely challenging. In the current proposal, we will try a slightly different approach that also can be used to expand regions in the brain that can be safely targeted by FUS.

Q. How will your new project advance the field of MR-guided FUS? What “chokepoint” will it address or eliminate?

McDannold: We hope to expand the number of patients with brain tumors or other central nervous system (CNS) diseases that can be treated with FUS instead of having to undergo surgery or other invasive procedures. Current technology limits FUS to targets that are distant from the skull. We hope that by using microbubbles, that we can ablate tissue with less energy. We hope that we can answer a lot of questions about the safety of this approach by testing the method using a realistic animal model and a FUS device made for patient use.

Q. What types of patients could benefit most from the treatments that emerge from your research?

McDannold: Brain tumor patients, primarily.

Q. What has FUSF funding meant to you and your work?

McDannold: The first FUSF gave us the opportunity to obtain pilot data that we hope will be turned into a long-term project. We probably would not have been able to obtain this funding through other mechanisms. Our new award is aimed at answering a pressing question about the safety of a particular FUS approach for brain tumor ablation. We had a unique opportunity to do this work, and the FUSF was able to quickly get us the funding needed to do this work before this opportunity passed.

Overall, it is fantastic to have dedicated funding for FUS projects. It is a way to obtain funding for completely new projects that, if successful, can be turned around for funding by other sources. It helps us move quickly to answer pressing questions that are holding up the progress of the field overall.

Q. Is there anything else you’d like to add?

McDannold: While my FUSF awards have been for work that is far from ready for clinical tests, my collaborators' experience with the foundation on FUSF clinical trials has been extremely positive, and those efforts are most appreciated. Also, the workshops put on by the FUSF are fantastic and get better every year.

The Foundation is pleased to welcome Arik Hananel, MD as its new Scientific and Medical Director. Hananel  was involved in the early stages of commercializing MR-guided focused ultrasound at device pioneer InSightec, Ltd. and has more than 12 years of research and development experience with the technology.

The pivotal positions Hananel held at InSightec give him a unique vantage point for advancing the Foundation’s mission: he is familiar with the clinical research funded by the Foundation, understands how the technology is evolving and has long-standing relationships with the key stakeholders in the field.

Arik Hananel, MD

“We are excited about the leadership role that Dr. Hananel will play at the Foundation. His in-depth knowledge of many facets of MR-guided focused ultrasound will be invaluable in helping to facilitate the adoption of this game-changing technology,” says Foundation Chairman Neal F. Kassell, MD.

Hananel’s primary responsibilities will be overseeing research activities, including pre-clinical studies and clinical trials, and representing the Foundation at meetings and symposia.

Hananel is passionate about accelerating the adoption of MR-guided focused ultrasound. “It can change medicine in a way that will benefit almost every patient,” he observes. “I remember seeing the first uterine fibroid treatments, and thinking about the contrast of the long recovery processes involved in other, more invasive procedures. I would watch a woman get treated with MR-guided focused ultrasound. Thirty-minutes later, I would be sitting with her, talking and joking. It continues to amaze me, even today.

“Once you see a patient receive the treatment, it changes your perspective completely. You need to see the person and not the procedure,” he says.

This enthusiasm for patients is natural to Hananel. Though his career has been in the corporate world, he trained as a clinical MD and almost became a pediatrician. However, as he says, “fate intervened” when he accepted a position at InSightec.

He is pleased that his new post at the Foundation will allow him to combine his medical degree with his two other degrees: a Bachelor’s of Computer Science and an Executive MBA. Aside from the great career fit, he considers the opportunity to be a personal “adventure.” Hananel, his wife, and three boys – ages 6, 11 and 14 – are relocating from their native Israel to Charlottesville, Virginia for the next chapter of their lives.

FUSF Research Award recipient:  Xin Chen, PhD, University of Arkansas for Medical Science, USA

Xin Chen, PhD

Hypoxic (oxygen-deprived) tumor cells usually resist radiation and chemotherapy, making them a key challenge in treating cancer. Researcher Xin Chen, PhD believes 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.

To test the method, Chen and his colleagues will conduct preclinical studies using a mouse tumor model and PET/MRI guidance. “Due to the advanced development in the MR-guided FUS system, PET imaging and the image-processing algorithm, there are no technical difficulties to translate this method to clinical practices,” Chen says.

If the approach proves effective, Chen believes it could convince more physicians to use noninvasive focused ultrasound as an adjuvant therapy. “The translation of FUS to tumor treatment has been hampered by its long treatment time,” he notes. Because the new method  involves significantly shortened treatments, Chen believes it could facilitate the use of FUS therapies in a wider range of tumors.

Chen’s co-investigators at the University of Arkansas for Medical Sciences are: Eduardo G. Moros, PhD, Robert J. Griffin, PhD, Peter Corry, PhD, Gal Shafirstein, PhD and Sunil Sharma, PhD.