In an important step forward for the widespread adoption of MRgFUS, Philips has begun installing its MR-guided focused ultrasound surgery units in the US during the past few months. Currently completing their pre-clinical studies, Philips will soon begin human clinical trials to further validate their device’s abilities.

The Philips MR High Intensity Focused Ultrasound (HIFU) device, which integrates with the Philips Achiva MR platform, consists of a patient tabletop containing the ultrasound transducers and a therapy-planning console that performs the surgical planning and real-time temperature tracking via MR during the procedure.
A distinguishing feature of the Philips system is the “volumetric treatment” concept. Instead of focusing the ultrasound beams on a single point within the targeted organ, sonicating the desired point, then moving on to the next point, the Philips system constantly moves the focal point within the targeted lesion. This allows a larger volume to be treated in a shorter period of time. This approach is very beneficial for patients in that they spend less time within the bore of the MR magnet. Faster treatment time is also a more attractive situation for hospitals wanting to utilize valuable MR time efficiently. Says Sham Sokka, Philips director of HIFU research, “The constant steering of the focused ultrasound beam under real-time thermal monitoring and MR guidance allows us to deliver the heat optimally. This approach limits the overheating situations and provides a safer treatment for patients.”

Philips will use three to four clinical sites for the pilot phase, including a system at the NIH and one at St. Luke’s Episcopal Hospital in Houston, Texas. Nine or 10 sites have been lined up globally for conducting the first clinical trials. One of the first human applications planned is the treatment of uterine fibroids, with several oncology applications expected to follow. Dr. John Fischer, an interventional radiologist at St. Luke's Episcopal Hospital and Baylor College of Medicine in Houston, Texas, has been conducting animal studies with the device. Dr. Fischer has an active Uterine Fibroid Embolization (UFE) practice and was one of many physicians who worked hard early on to establish insurance reimbursement for UFE before the procedure was widely accepted.

"...With its volumetric heating capability, the Philips device has the ability to perform uterine fibroid and other treatments incredibly fast" - Dr. John Fischer

“As a whole, the MRgFUS field is a very exciting field of medicine – very fertile for innovation and the treatment of various disease states,” says Dr. Fischer. “With its volumetric heating capability, the Philips device has the ability to perform uterine fibroid and other treatments incredibly fast. Our initial studies will focus on safety and efficacy as we continue to refine protocols and improve treatment times.”

Details of the Philips MR guided focused ultrasound system will be presented at the upcoming MRgFUS Symposium sponsored by the Focused Ultrasound Surgery Foundation.

The phase 1 clinical trial for the MR guided focused ultrasound treatment of pain caused by bone metastases was completed in March 2008 with over 30 patients treated. The results of the trial are now beginning to be published, with very promising results. The larger phase 3 clinical trial began this spring with 6 patients having been treated so far.

Pain from bone metastases is the most common cause of cancer pain and is common during metastasizing cancer, particularly cancer of the prostate and breast. Current treatments for patients with bone metastases is primarily palliative, with external beam radiation therapy (EBRT) being the standard of care for patients. EBRT can provide pain relief for patients in approximately 70% of bone metastases patients, but pain relief is not immediate. The speed of response to EBRT varies; from the patients that respond most symptomatic bony metastases begin to respond over the course of 10 to 14 days, 70% of patients experience some pain relief within 2 weeks of starting therapy and, within 3 months 90% of patients achieve pain relief.

The MRgFUS treatment is based on the fact that bone readily absorbs acoustical energy. Using MR guidance, the focal beam of the ultrasound array is used to heat the targeted bone. This heating ablates the innervation to the periosteum, the thin membrane covering the bone in which the bone metastases causes pain. The energy used in the treatment is roughly half that used in the treatment of uterine fibroids using MRgFUS, so the treatment is less likely to cause complications. Pain relief from the MRgFUS treatment can be very rapid as well.

A pilot study using MRgFUS to manage pain from bone metastases was completed in Israel in 2006 using the Insightec ExAblate 2000 MRgFUS system and in June 2007 the data from this and other studies was used to support CE mark certification for the InSightec system for use in Europe.

Clinical Results
A subset of the results from the phase 1 clinical trial will be published in the October 2008 edition of the journal Radiology. The published results come from 12 lesions treated in 11 patients treated at the University of Toronto by Dr. David Gianfelice and others. The tumors were located in the iliac, scapula, clavical, and ischium bones with the average treatment time taking approximately 51 minutes. Patients were asked to rate their pain levels on a scale of 0 to 10 before and after the MRgFUS treatment. Pre-treatment, the average pain score was reported as 6.0. Three months post-treatment, the average pain score was reduced to 0.5, representing a 92% decrease. No treatments had any adverse effects based on follow-up physical exams or imaging studies. Dr. Gianfelice will be discussing more of his clinical results at the MRgFUS 2008 Symposium.  Full results of the phase 1 clinical trial will be published in an upcoming paper.

The phase 3 clinical trial will involve approximately 150 patients from multiple treatment centers. The 6 patients treated so far have been treated at the University of California San Diego, Brigham and Women's Hospital, and Methodist Hospital Research Institute. For a full list of clinical trial sites and the inclusion/exclusion criteria, see the following web site:

http://www.clinicaltrials.gov/ct2/show/NCT00656305

A new, fully interactive web site called FibroidRelief (www.fibroidrelief.org) is being launched by the Focused Ultrasound Surgery (FUS) Foundation. The site provides valuable resources for patients interested in learning more about the use of Focused Ultrasound for treating uterine fibroids.

Along with the new web site, FUS Foundation will begin distributing patient education materials at FUS treatment sites and Ob/Gyn clinics across the country. The educational brochure is an excellent starting point for women seeking a fact-based comparison of treatment options for uterine fibroids. The brochure provides in-depth information about focused ultrasound treatment and presents much of the web site content in printed form.

With FibroidRelief, we want to reach out to patients, hear their stories, share their concerns, and develop an interactive and educational resource for all women with uterine fibroids. Many will find focused ultrasound their best option, some may prefer other treatments. Whatever your choice, FibroidRelief will help you to make an informed decision.

We hope you’ll check out www.fibroidrelief.org, JOIN FibroidRelief, participate in the Message Boards, share your own story, and find strength in the stories of others. FibroidRelief strives to put the power of choice into the hands of women suffering with uterine fibroids. So get involved and JOIN FibroidRelief today – we want to hear from you!

In our continuing commitment to advance the field of MRgFUS, the Foundation has brought additional expertise to bear in our organization.

JOHN GRISHAM Joins the FUSF Board of Directors
Mr. Grisham, an internationally acclaimed author whose works include #1 best sellers A Time to Kill, The Firm, The Pelican Brief, The Runaway Jury, and others, many of which have been made into tremendously successful motion pictures, has been elected to the Board of Directors for a three-year term. Mr. Grisham's role will be two-fold: First, to help obtain the philanthropic support necessary to accelerate the development of this exciting field; and, secondly, to increase the awareness of this innovative therapeutic approach.

JOY POLEFRONE, PhD Joins as FUSF Director of Patient Support Organizations
Dr. Polefrone brings a wealth of scientific, biomedical and technology development experience to the FUSF. She earned her PhD in Chemistry at the University of Virginia, researching applications of proteomics in the areas of cancer vaccines and immunotherapy, and more recently worked as a biotech equity analyst at CRT Capital Group in Stamford, CT.

Dr. Polefrone will oversee the development and implementation of patient support organizations as well as work collaboratively in supporting the goals and objectives of the Foundation's Research Programs. Joy’s most recent work at the Foundation involves the launch of Fibroid Relief (www.fibroidrelief.org), a patient support organization dedicated to increasing awareness amongst women with uterine fibroids about non-invasive treatment options, and specifically about focused ultrasound.

HEATHER HUFF-SIMONIN Joins FUSF as Director of Principal Gifts and International Business Development
Heather’s primary activities will include Principal Gift Fundraising and European Research Site Development.

Ms. Huff-Simonin has over 10 years experience in International Business Development. Her experience spans across two continents working in both Europe as well as the United States. Prior to receiving her MBA from the Darden School of Business Administration, Heather was an Associate at Donaldson, Lufkin and Jenrette in Paris, France and then spent 4 years in a sales/marketing role for Eli Lilly Company’s US operations.