Posted on: 09/28/2007
InSightec Resumes Clinical Trials for Non-Invasive Treatment of Brain Tumors
HAIFA, Israel, September 25 /PRNewswire/ -- InSightec Ltd. has begun
the second stage of its FDA approved Phase I clinical trial for
non-invasive treatment of brain tumors using MR guided Focused Ultrasound
Surgery on the ExAblate(r) system.
The objectives of the study are to evaluate the safety of focused
ultrasound delivered through an intact skull and to estimate the effect of
the thermal ablation on the tumors. Patients with recurrent and inoperable
glioblastomas or cerebral metastases are being recruited for this study.
ExAblate(r) uses high-intensity focused ultrasound waves to ablate
(destroy) tissue in combination with Magnetic Resonance Imaging (MRI). The
system provides visualization of the tumor and acoustic energy beam path as
well as real time thermal feedback that allows the physician to monitor and
control the treatment process.
Three patients with recurrent glioblastoma have already been treated at
Brigham and Women's Hospital in Boston, evaluating the ability of the
ExAblate system to safely reach a targeted tumor. Based on the safety
profile submitted for review, the FDA recently approved the continuation of
the trial.
"The ExAblate MRgFUS technology has significant potential as a
non-invasive and non-ionizing tumor therapy, and offers an important
potential alternative or adjunct to radiation therapy, and eventually, for
brain surgery" says Ferenc Jolesz, MD Professor of Radiology, Brigham and
Women's Hospital, Boston MA.
Dr. Peter Black, Professor of Neurosurgery at the Brigham and Women's
Hospital and co-director of the study adds that "The challenge of brain
tumor surgery is to achieve complete tumor removal or the greatest possible
extent of tumor reduction without causing brain injury. This feasibility
study will significantly advance our understanding of the potential of this
technology for brain tumor treatment and if successful, prepare the way for
a clinical efficacy study."
Further details of ExAblate technology and clinical experience can be
found at http://www.insightec.com. Details about the clinical trial can
also be found at Clinical Trials.gov
(http://www.clinicaltrials.gov/ct/show/NCT00147056;jsessionid=
DA645CDD9781968B8BF5161676409C8B?order=4)
(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)
About ExAblate
The ExAblate(r) is the first system to use the breakthrough MRgFUS
technology that combines MRI - to visualize tissues in the body, plan the
treatment and monitor in real time treatment outcome - and high intensity
focused ultrasound to thermally ablate uterine fibroid tissue. MR thermal
feedback, provided uniquely by the system, allows the physician to control
and adjust the treatment in real time to ensure that the targeted tumor is
fully treated and surrounding tissue is spared. ExAblate received FDA
approval for the treatment of symptomatic uterine fibroids in October 2004.
ExAblate has been recognized for its innovation and potential to serve
mankind and has been awarded the 2004 European Union's Information Society
Technologies grand prize, The Wall Street Journal's 2004 Technology
Innovation Awards, Advanced Imaging's 2005 Solutions of the Year and, the
Red Herring 100 Europe 2007 Award.
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Medical
Imaging (EMI), General Electric, MediTech Advisors, LLC and employees. It
was founded in 1999 to develop the breakthrough MR guided Focused
Ultrasound technology and transform it into the next generation operating
room. Headquartered near Haifa, Israel, the company has over 135 employees
and has invested more than $100 million in research, development, and
clinical investigations. Its U.S. headquarters are located in Dallas,
Texas. For more information, please go to: http://www.insightec.com/
Contact Information:
InSightec Ltd.
http://www.insightec.com/
Tel: +972-4-813-1313
Email: info@insightec.com
For media inquiries:
Fern Lazar
Lazar Partners, Ltd.
Tel: +1-212-867-1762
Email: flazar@lazarpartners.com
For medical inquiries:
Black, Peter Mclaren,M.D.,Ph.D.
Prof. of Neurosurgery
Department of Neurosurgery
Brigham and Women's Hospital
Harvard Medical School
75 Francis Street, Boston MA 02115
Tel: +1-617-732-6600
Fax: +1-617-734-8342
E-mail: pblack@partners.org
Ferenc A. Jolesz, MD.
B. Leonard Holman Professor of Radiology
Vice Chairman for Research
Director, Division of MRI and Image Guided Therapy Program
Department of Radiology
Brigham and Women's Hospital
Harvard Medical School
75 Francis Street, Boston MA 02115
Tel: +1-617-732-5961
Fax: +1-617-582-6033
E-mail: jolesz@bwh.harvard.edu
For media inquiries Brigham and Women's Hospital:
Jessica Podlaski
Media Relations Coordinator
Brigham and Women's Hospital
321 Columbus Avenue
Boston, MA 02116
Phone: +1-617-534-1603
Fax: +1-617-534-1610
Pager: +1-(617)-732-6660 #33916
E-mail:jpodlaski@partners.org
SOURCE InSightec Ltd
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