Focused Ultrasound Surgery Foundation

Promoting the advancement and adoption of MR guided focused ultrasound surgery.

 
Newsletter Articles
Leading experts join FUS-TDD Core Stakeholder’s Group


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:

“Core stakeholders will identify two to four high potential clinical applications for FUS-TDD and help develop research road maps for them.”
Joy Polefone, Ph.D.
FUS-TDD Program Director

  • Matt Dreher, Ph.D., NIH, Bethesda, MD
  • Keyvan Farahani, Ph.D., NIH, Bethesda, MD
  • Katherine Ferrara, Ph.D., UC Davis, Davis, CA
  • Holger Gruell, Ph.D., Eindhoven University of Technology, Eindhoven, The Netherlands
  • Joo Ha Hwang, M.D., Ph.D., University of Washington, Seattle
  • Kullervo Hynynen, Ph.D., Sunnybrook, Toronto, Canada
  • Alexander L. (Sasha) Klibanov, Ph.D., University of Virginia, Charlottesville, VA
  • Joseph Kost, Ph.D., Ben-Gurion University of the Negev, Beer-Sheva, Israel
  • King Li, M.D., M.B.A., Methodist Hospital, Houston, TX
  • Nathan McDannold, Ph.D., Brigham & Women’s Hospital, Harvard Medical School, Boston, MA
  • Andreas Melzer, Ph.D., University of Dundee, Dundee, UK
  • Chrit Moonen, Ph.D., University of Bordeaux, Bordeaux, France
  • Rich Price, Ph.D., University of Virginia, Charlottesville, VA
  • Brad Wood, M.D., NIH, Bethesda, MD

 

According to Joy Polefone, Ph.D., director of the FUS-TDD Program, core stakeholders will form a working group and invite participation by ad hoc attendees when needed. Initially, the group will  identify key research questions and gating factors to developing clinical applications as well as two to four high potential clinical applications. The group will also help develop research road maps for those applications and serve as implementation leaders within their areas of expertise.

The FUS-TDD Program is aimed at accelerating the availability of new, noninvasive patient treatments that precisely deliver drugs.

Expected to be used for many chronic and life-threatening conditions, FUS-TDD treatments will combine the advanced imaging techniques of MR-guidance with the thermal or mechanical energy of focused ultrasound and new drug transport systems. Instead of dispersing therapeutic agents throughout a patient’s body, the treatments will deliver drugs to specific diseased tissue. For example, targeted chemotherapy treatments will deposit drugs to cancerous tissue and not impact healthy tissue, eliminating most if not all of the systemic side effects associated with current approaches.

The Foundation’s FUS-TDD program has three long-term goals: 1) identify the clinical applications that will benefit most from MR guidance; 2) develop a research roadmap for clinical applications for MR-guided FUS-TDD; and, 3) spur research by fostering collaboration among academic researchers, pharmaceutical manufacturers, focused ultrasound companies and the clinical community.

Last Updated ( Friday, 09 July 2010 06:04 )
 
Fibroid Relief plans July 31 Coffee and Conversation event in London


The Foundation’s patient support organization, Fibroid Relief, will conduct its second Coffee and Conversation event in London on Saturday, July 31.

“Our goal is to educate women about non-invasive treatment options for uterine fibroids. The format of Coffee and Conversation events is much like a support group, with doctors and patients sharing information about different treatments, alternative medicine, fertility, referrals and more.”
Tina Krall
Executive Director, Fibroid Relief

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.

The MR Therapy Centre team from St Mary’s will facilitate the discussion and answer questions about treatment options, including focused ultrasound. Stephen Quinn, M.D., a gynecology fellow who specializes in fibroid care, will be the guest speaker.

“Our goal is to educate women about non-invasive treatment options for uterine fibroids, and Coffee and Conversation events are a direct way to share information with patients,” says Tina Krall, executive director of Fibroid Relief. “These gatherings are designed to be more intimate and informal than our larger Fibroid Relief At Last events. The format is much like a support group, with doctors and patients sharing information about different treatments, alternative medicine, fertility, referrals and more.”

For additional information on Fibroid Relief and other upcoming events in the U.K. and U.S., visit www.fibroidrelief.org or contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
Last Updated ( Friday, 09 July 2010 12:01 )
 
Foundation participates in FDA-sponsored satellite symposium on imaging-mediated targeted drug delivery


"Imaging-mediated Drug Delivery, from Bench to Bedside," was the title of a June 25 satellite symposium held in conjunction with a three-day workshop for cancer researchers sponsored by the FDA and several other leading organizations.

Joy Polefone, Ph.D., director of the Foundation’s newly-launched Focused Ultrasound-mediated Targeted Drug Delivery (FUS-TDD) program, was a speaker at the event.  As she observed, “The symposium offered an important opportunity to present the concept of Image-guided Mediated Targeted Drug Delivery, of which FUS-TDD is a key example, to the FDA for potential inclusion in the full workshop in the future.”

Polefone added, ”This could be an important step in initiating a dialogue involving the FDA, academics, and the national labs about the optimal process for evaluation of nanoparticle and drug delivery agents that will facilitate commercial success.”

The satellite symposium was organized by H. Kim Lyerly, M.D., director of the Duke University Comprehensive Cancer Centre, and Professor Andreas Melzer, director of the Institute for Medical Science and Technology (IMSaT) at the Universities of Dundee and St. Andrews in Scotland.

Program presentations included overviews of the technology and current preclinical and clinical results related to imaging-mediated drug delivery. At the program’s conclusion, a roundtable discussion explored the options and potential hurdles for the regulatory pathways. Featured presenters were:

  • Integration of Multi Modality Imaging with Guided Drug Therapy” – Prof. Andreas Melzer “Technology of Magnetic Resonance Guided Focused Ultrasound” – Yoav Medan, D.Sc., M.B.A., InSightec, Haifa, Israel
  • “Focused Ultrasound Targeted Drug Delivery, Preclinical Evaluation and Preliminary Results” –  Nathan McDannold, Ph.D., National Center for Image Guided Therapy (NCIGT), Brigham and Women’s Hospital, Harvard Medical School, Boston, M
  • "Focused Ultrasound-mediated Targeted Drug Delivery: FUS Foundation's Collaborative Model toward Research Roadmap Development" – Joy Polefrone
  • "Effect of Particle Size Distribution and Surface Characteristics on Biodistribution of Potential Drug Carriers" – Richard A. Frank, M.D., Ph.D., GE Healthcare, Princeton, NJ
  • “Regulatory approach to combined technologies of imaging with drugs” – Roundtable Discussion moderated by Dr. Lyerly

 

Last Updated ( Friday, 09 July 2010 06:53 )
 
Utah researcher developing FUS treatments for breast and liver cancer

Funded project will develop temperature measuring techniques for treating breast and liver cancer with MR-guided focused ultrasound

nick_todd
Nick Todd, Ph.D. is the Foundation’s newest Research Award recipient

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.

Todd, a post-doctoral researcher in the UU Department of Radiology, recently received a $100,000 Research Award from the Focused Ultrasound Surgery Foundation. Entitled, “Robust MR Thermometry for MRgHIFU in Breast and Liver: Joint Research between University of Utah and University of Geneva,” his project involves the development of temperature measuring techniques that accelerate data acquisition speed and are robust in the presence of motion.

Todd’s co-investigators are Dennis Parker, Ph.D., Professor of Radiology at UU and Rares Salomir, Ph.D., a research scientist at the University of Geneva. He describes details of the group’s research below.

The Foundation’s newest Research Award recipient, Nick Todd, and his colleagues are developing MR temperature measuring techniques that overcome 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.

Q. What prompted your interest in performing this research?

Our group has a four-year R01 grant from the NIH to develop a breast specific MR-guided high intensity focused ultrasound system. One of the challenges in this project is to develop MR temperature measurement techniques that overcome the unique set of problems posed by imaging in the breast. The solution will have to be able to measure temperature changes in adipose tissues, be robust to motion-related errors, and be able to image a large volume with high spatial and temporal resolution. We have submitted a separate proposal to the NIH to tackle the problem of measuring temperature changes in adipose tissues and the work to be done in this project takes on the remaining challenges of motion and volumetric imaging.

The research is interesting to us because it allows us to investigate a number of difficult problems regarding MR temperature measurements, and the results will be directly applicable to our larger goal of developing a breast specific MRgHIFU system.

Q. How could the temperature measurement techniques you are investigating accelerate the development of MR-guided FUS treatments for breast and liver tumors?

A lot of excellent work has been done in the past 10 to 15 years on MR thermometry, allowing non-invasive thermal therapies to be partially monitored and controlled in real time.

In our view, a few obstacles still need to be overcome before MR thermometry can provide the reliable and comprehensive monitoring of heat deposition that clinical applications require. These include measuring temperature changes in adipose tissues, robust handling of motion, and larger volume coverage at acceptable spatial and temporal resolution. If successful, the work done in this project will help to overcome the second and third of these challenges.

We are focusing on implementing our methods in the breast and liver but the techniques developed will be applicable to any organ.

Q.  Why is it important for these new techniques to be robust to motion-related errors?

Physiological motion, for example due to breathing or cardiac function, cannot be avoided during MRgHIFU treatments in certain organs. Image artifacts and misalignment will cause temperature errors when objects inside the imaging field of view are moving. And changes in the local magnetic field will cause temperature errors when objects outside of the imaging field of view are moving. Imaging in the liver is an example of the first type of motion-related error, and imaging in the breast is an example of the second type. If not corrected, these effects can lead to temperature measurement errors of 5°C to 10°C.

Q.  How could your findings be useful in developing MR-guided FUS treatments for other areas of the body?

“We greatly appreciate the support from the FUS Foundation. The peer review process is excellent and provides good feedback during the application process, and the funding is a key component of building a broad-based FUS research program.”
Nick Todd

The problems of motion detection and correction and of volumetric imaging that we are working on would be beneficial to all MRgHIFU treatments.  Motion can be a problem in a number of organs, and even in locations where physiological motion is not occurring, inadvertent patient motion can happen and must be detected. Additionally, monitoring temperature over a larger volume would be desirable for all applications.

Q.  Please describe the key steps of your research project and the specific roles being played by the University of Utah and the University of Geneva.

The research will progress in two phases.

In the first phase, we are testing novel motion detection and correction techniques against the current gold standards. We will implement the reference-less thermometry technique developed by Dr. Salomir at the University of Geneva for breast imaging and compare it to currently used reference-less techniques. We will also test a motion detection technique developed at the University of Utah against currently used techniques.

In the second phase of the project we will take the best reference-less and motion detection techniques and integrate them into the University of Utah’s method for 3-D volumetric imaging. The 3-D technique uses an under-sampled 3-D segmented EPI sequence and incorporates a biophysical model to reconstruct temperature maps with large volume coverage, good spatial resolution and high temporal resolution.

Q.  How will this research project tie-in to any other MR-guided FUS research being performed at UU or Geneva?

As mentioned above, this project will directly benefit the University of Utah’s NIH R01 grant for developing a breast-specific MR-guided HIFU system. It will also strengthen two NIH proposals that are now in review, and will lead to future proposals for additional research and collaborations with Geneva and other groups.

utah_group
The HIFU research team at the University of Utah

Q.  How important to achieving your research goals is the research award received from the FUS Foundation?

The support that we have received from the FUS Foundation is critical to achieving our goals. In the short term, it has allowed the principal investigator, Nick Todd, to remain at the Utah Center for Advanced Imaging Research (UCAIR) as a postdoctoral research associate; will fund data acquisition for this project; will allow for travel between the University of Utah and the University of Geneva to facilitate the exchange of ideas and techniques; and will allow the investigators to present their findings at major scientific meetings.  In the longer term, we plan to use the results of this project to help with future applications for funding and intend to develop the relationship between the University of Utah and University of Geneva into a longstanding collaboration.

Q.  What other thoughts, insights or observations would you like to add?

We greatly appreciate the support from the FUS Foundation.  The peer review process is excellent and provides good feedback during the application process, and the funding is a key component of building a broad-based FUS research program.

Last Updated ( Friday, 09 July 2010 06:54 )
 
UVA Focused Ultrasound Center of Excellence launches clinical trials program


Researchers are using new generation of MR-guided focused ultrasound equipment to treat patients with uterine fibroids and pain from metastatic bone tumors.

paul_read
Paul Read, M.D., of UVA’s Department of Radiation Oncology, is principal investigator for two clinical trials related to pain resulting 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.

Recently launched, the center’s first clinical trial is a pivotal (Phase 3) study investigating the safety and efficacy of MR-guided focused ultrasound treatment for pain associated with metastatic bone tumors. Typically, pivotal studies support the submission of a premarket approval (PMA) application to the FDA for a new device or a new use of that device. In this case, research is supporting a new use of Insightec’s ExAblate 2000, which received FDA approval for the treatment of uterine fibroids in 2004.

The UVA center will begin two more clinical trials this summer. One will be a feasibility (pilot) study of the safety and initial efficacy of the new ExAblate 2100 Conformal Bone System in treating pain resulting from metastatic bone tumors. UVA will be one of two sites conducting this study, which is expected to enroll a total of 50 patients.

The second study will evaluate the safety of the ExAblate 2100 Uterine Fibroid V2 System in treating symptomatic uterine fibroids.

The studies are being funded by InSightec of Triat Carmel, Israel, manufacturer of ExAblate systems.

matsumoto
Alan Matsumoto,M.D., chair of UVA’s Department of Radiology, will be principal investigator of a clinical trial of a new generation ExAblate system for the treatment of uterine fibroids.

Now underway:

A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy (Principal Investigator: Paul Read, M.D., Department of Radiation Oncology)

Study overview:

  • Open to men and non-pregnant women, age 18 or older, who have pain caused by cancer that has metastasized to the bone
  • Evaluating the safety and effectiveness of an experimental device (ExAblate) in the treatment of pain caused by metastatic bone tumors or multiple myeloma
  • Device will be used to treat bone tumors located in ribs, extremities (excluding joints), pelvis, shoulders and limited areas of the sacrum

 

Link to study information:

http://www.healthsystem.virginia.edu/internet/clinical_trials/detail.cfm?trial_id=14601

Pending studies:

A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR-Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System (Principal investigator: Paul Read, M.D., Department of Radiation Oncology)

A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids (Principal investigator: Alan Matsumoto, M.D., Department of Radiology)

Last Updated ( Friday, 09 July 2010 06:55 )
 
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