Interim analysis of triple-blind, parallel-controlled trial proves
intraoperative MRI more effective than conventional neurosurgery for
certain brain tumors
MINNEAPOLIS, Aug. 26, 2014 /CNW/ - IMRIS Inc. (NASDAQ: IMRS; TSX: IM)
("IMRIS" or the "Company") today announced that a recently published
article in the journal Neurosurgery is the highest level clinical evidence to show that the use of VISIUS® intraoperative MRI (iMRI) in brain tumor surgery results in complete
tumor removal in more patients with glioma tumors.
Led by Dr. Jin-song Wu, the neurosurgical team at Huashan Hospital at
Fudan University in Shanghai, China, conducted the study and wrote the
interim analysis article that was published in August. Dr. Wu and the
clinical team were honored with the Journal of Neuro-Oncology Award at
the Congress of Neurological Surgeons (CNS) Annual Meeting in October
2013 for their study design and abstract.
The prospective, parallel, randomized, triple-blind controlled trial
design provides the most objective data and therefore highest level
evidence to date of the value of iMRI in treating both low and
high-grade gliomas. The early results reinforce that high-field
iMRI-guided surgery is more effective in achieving complete resection
than conventional neuronavigation-guided surgery. Other published
studies on high-field iMRI have been mainly retrospective.
"iMRI is a practical and valuable asset to increasing the extent of
resection for cerebral gliomas, with a specific significant influence
for low grade gliomas," Dr. Wu said. "With trends to statistical
significance, these early results are the highest level of iMRI
evidence for glioma surgery now available. This leads to more improved
overall survivability and quality of life than using conventional
The low-grade glioma (LGG) subgroup patients who were treated in a
VISIUS Surgical Theatre using iMRI had a statistically significant
complete resection rate of 82 percent compared to 43 percent for the
control group of conventional surgery patients. For the high-grade
glioma (HGG) patients, 91 percent of those treated with iMRI had
complete resection compared to 73 percent for the control group. These
results are confirmed by volumetric analysis. The LGG subgroup met the
endpoint early and that arm of the study stopped enrolling additional
patients. The study continues for HGG patients.
Jay D. Miller, IMRIS CEO and President, noted, "Clearly these studies
continue to show the benefit of having the level of MR imaging the
IMRIS solution provides inside the operating room without moving the
patient. We know certain surgeons won't do these types of procedures
without being in our surgical suites. In time, use of VISIUS iMRI will
develop into a standard of care in these cases."
The IMRIS VISIUS Surgical Theatre with iMRI at Huashan Hospital provides
neurosurgeons high-quality MR images during surgery to see the area of
the brain they are operating on in exquisite detail, see tumor size and
shape, and distinguish between healthy and unhealthy tissue more
easily. The surgeon can take images before completing the surgery and
check if additional tumor or abnormal tissue removal is needed to
reduce risk of re-operation.
Unlike other iMRI systems, the IMRIS scanner moves between two adjoining
rooms - one intended for surgery and the other for diagnostic scanning
- on ceiling-mounted rails to the patient so the surgical team can
maintain optimal surgical positioning, access and techniques without
moving the patient.
One of five VISIUS Surgical Theatre installations in China, more than
1,000 patient procedures have been completed using the Fudan University
iMRI since its installation in Sept. 2010.
For the complete article, see the August issue (Volume 61) of
Neurosurgery, pp. 145-154, for "3.0T iMRI Guided Resection in Cerebral
Glioma Surgery: Interim Analysis of a Prospective, Randomized,
Triple-blind, Parallel-controlled Trial": http://journals.lww.com/neurosurgery/Citation/2014/08001/3_0_T_Intraoperative_Magnetic_Resonance.31.aspx.
IMRIS (NASDAQ: IMRS; TSX: IM) is a global leader in providing image
guided therapy solutions through its VISIUS Surgical Theatre - a
revolutionary, multifunctional surgical environment that provides
unmatched intraoperative vision to clinicians to assist in decision
making and enhance precision in treatment. The multi-room suites
incorporate diagnostic quality high-field MR, CT and angio modalities
accessed effortlessly in the operating room setting. VISIUS Surgical
Theatres serve the neurosurgical, spinal, cardiovascular and
cerebrovascular markets and have been selected by 61 leading medical
institutions around the world.
Image with caption: "The IMRIS VISIUS iMRI at Huashan Hospital in Shanghai, China, provides neurosurgeons high-quality MR images during surgery which results in more complete brain tumor removal in patients. (CNW Group/IMRIS Inc.)". Image available at: http://photos.newswire.ca/images/download/20140826_C7907_PHOTO_EN_42537.jpg
SOURCE: IMRIS Inc.
For further information:
Kevin J. Berger
Marketing Communications Manager