MEDICAL DEVICE INNOVATION - Medical Device Daily

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138 Researchers find HIFU suitable for brain surgery procedures By OMAR FORD Medical Device Daily Staff Writer A team of researchers at MR-Center of the University Children’s Hospital (Zurich, Switzerland) are one step closer to providing noninvasive procedures in nearly every part of the body using MRI guided ultrasound. They recently completed a pilot study using transcranial MR-guided high intensity focused ultrasound (HIFU) to treat 10 patients with neuropathic pain (Medical Device Daily, July 15, 2009). The origin of chronic pain in these patients included post amputation phantom limb syndrome, nerve injury, stroke, trigeminal neuralgia and post herpetic neuralgia from shingles. The researchers implemented and optimized a prototype system for transcranial magnetic resonance-guided high-intensity focused ultrasound (HIFU) for neurosurgical interventions. The HIFU system ExAblate 4000, developed by InSightec (Dallas), has been combined with a 3 Tesla high field GE MR-scanner. The two systems together provide a platform for image-guided, non-invasive interventions. These findings are set to be published in a forthcoming issue of Annals of Neurology and have the potential to turn the way the medical community thinks about HIFU on its ear, say researchers of the study. Neal Kassell, MD, a neurosurgeon at the University of Virginia (Charlottesville), and chairman of the Focused Ultrasound Surgery Foundation, which helped fund the study, said that the benefits of this procedure were numerous. “First of all it’s totally non invasive and you’re able to treat the patient in real time. Plus the effect of the procedure is known immediately,” Kassell told Medical Device Daily. “It’s proof that through the intact skin and skull you can make lesions in an awake person’s brain,” he said. “These results are huge milestone in the field of focused ultrasound. The fact that you can treat the brain with this procedure means you can treat other things. I think in the next few years we’ll see the liver, pancreas and prostate treated this way.” The study was partially funded by the Focused Ultrasound Surgery Foundation. The Foundation funds translational and clinical research into new therapeutic applications of MR-guided focused ultrasound (MRgFUS). The preliminary results in these patients are consistent with conventional therapy – radio frequency ablation - which is an invasive procedure and involves making an MEDICAL DEVICE INNOVATION 2010 incision in the scalp, drilling a hole in the skull, inserting an electrode through normal brain tissue into the thalamus, and using radio frequency to create the lesion. Researchers say the procedure is painless and quick. Instead of going in for surgery, the patient is basically going in for an MRI. The patient is sent through an MRI scanner similar to a regular diagnostic MRI scanner only this scanner has a special ultrasound system integrated into it which can non-invasively ablate tissue inside the brain. It essentially is an outpatient procedure and no anesthesia is used at all. “This research demonstrates that transcranial MR-guided focused ultrasound can be used non-invasively to produce small thermal ablations with extreme precision and accuracy deep in the brain,” he said. The study proved that researchers can perform successful operations without opening the cranium or physically penetrating the brain with medical tools, something that appeared to be unimaginable only a few years ago. According to Kassell, the key advantage of focused it safer than conventional surgery because it avoids the associated risks of complications such as infection, hemorrhage, and collateral damage to normal brain structures. For years, HIFU has been used for the treatment of uterine fibroids and tumors of the prostate gland. However, its application to the brain through the intact skull for noninvasive neurosurgery was not possible until recently, because of complications. The plan now is for other research sites are now expected to initiate clinical studies using Transcranial MRguided focused ultrasound for brain disorders within the next year, including studies for Parkinson’s disease, essential tremor, and brain tumors. “I posit that in 10 years from now that people will either be treated by this procedure or they’ll know someone who has been treated by this procedure,” Kassell said. “But for now we’re very very, very much on the ground floor.” (This story originally appeared in the Aug. 12, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 New imaging analysis provides new ‘map’ for tumor survival By ROB KIMBALL Medical Device Daily Staff Writer One of the constant barriers that physicians, and their patients, seem to encounter is the battle against time. In the case of tumor treatments and diagnosis, researchers have published a study that could save time to recovery if a treatment isn’t working for a patient — via a new way of observing a standard MRI. As early as one week after beginning treatment for brain tumors, a new imaging analysis method was able to predict which patients would live longer, researchers from the University of Michigan Comprehensive Cancer Center (Ann Arbor) have found. The method uses a standard magnetic resonance imaging (MRI) protocol to monitor changes over time in tumor blood volume within individual voxels of the image, rather than a composite view of average change within the tumor. This parametric response map (PRM) allowed researchers to see specific areas in which tumor blood volume increased or decreased, that may have canceled each other out when looking at the changes as an average. Results of the study appear in the advance online edition of Nature Medicine. Craig Galban, PhD, assistant professor of radiology at the U-M Medical School and the study author, told Medical Device Daily that this could be a “huge paradigm shift” if clinicians go in this new direction. Galban describes the potential for this imaging analysis as “adaptive therapy.” The researchers looked at 44 people with high-grade glioma, a type of brain tumor, who were treated with chemotherapy and radiation. Each participant underwent MRIs before treatment, and one week and three weeks after starting treatment. The researchers then looked at the relative cerebral blood volume and the relative cerebral blood flow of the tumor to analyze voxel-wise changes among the serial scans. Looking at standard comparisons using averages, the scans indicated no change one week and three weeks into treatment. But, using the parametric response map approach, the researchers were able to show changes in the tumor’s blood volume and blood flow after one week that corresponded to the patient’s overall survival. “Right now, physicians have to wait until the treatment is over to determine if it was effective. We are proposing that we can determine right away if the treatment is effective. If it is not working, then we can tailor the therapy rapidly to the individual. We are trying to personalize the care and get this valuable and accurate information to the clinician so that they can make a decision on the proper course of treatment for the patient,” Galban told MDD. High-grade gliomas have a high-mortality rate, with 139 people surviving only an average of 12 months after diagnosis. Typically, patients receive six to seven weeks of treatment, followed by a traditional MRI scan six weeks after completing therapy to determine if the tumor shrank. If the cancer did not respond to the treatment, a new approach may be tried. A voxel is a volume element, representing a value on a regular grid in 3-D space, as compared to a pixel which is 2- D. As with pixels, voxels themselves typically do not contain their position in space (their coordinates) — but rather, it is inferred based on their position relative to other voxels (i.e., their position in the data structure that makes up a single volume image). Galban explained the differences in standard imaging analysis compared to PRM for MDD. “It’s really looking at voxel-wide changes,” he said. “PRM is measuring the changes in blood volume in these individual voxels. The standard way to look at the functional data [such as an MRI on a tumor] is to take all the information and gather it into a mean, or average. We are proposing not just to look at the statistical average of all the voxels and blood volume, but to examine them discreetly and individually, and determine spatially how much of the tumor did respond to treatment. These are highly heterogeneous tumors. Some of the tumor might have responded well to the treatment, but another part of the tumor may not. So that’s how BPM differs — it is really looking at changes in the blood volume in the individual voxels. We’re interested in how much of that tumor volume changes. “ The researchers believe this approach might also be useful with other imaging techniques such as PET and CT scans. (This story originally appeared in the April 28, 2009, edition of Medical Device Daily). To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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