Trial to Test Ultrasound/MRI for Brain Cancer

(DARPA.gov)

27 November 2017. A developer of a technology that combines ultrasound and MRI scans plans to begin a clinical trial of its techniques to improve delivery of drugs to treat a form of brain cancer. Insightec, a medical device company in Tirat Carmel, Israel says it received approval from the U.S. Food and Drug Administration to test MRI-guided ultrasound in patients with glioblastoma, an aggressive form of brain cancer.

Glioblastoma forms in the brain’s glial cells that support the functioning of neurons in the brain sending and receiving nerve signals. The cancer generally grows and spreads quickly, often resulting death within 15 months of diagnosis. The genetic make-up of glioblastoma can also vary from one person to the next, making it more difficult to find treatments. American Association of Neurological Surgeons estimates glioblastoma, also known as glioblastoma multiforme, occurs in 2 to 3 out of 100,000 adults per year, and accounts for 52 percent of all primary brain tumors.

One of the difficulties in treating glioblastoma and other neurological disorders is the blood-brain barrier, a support network for brain functions, with tightly-packed cells lining blood vessels that allow nutrients to pass through, but keeping out foreign substances. This barrier also keeps out drugs to treat neurological conditions, such as Parkinson’s and Alzheimer’s disease as well as glioblastoma. So far, no efficient method is available to penetrate this barrier that prevents most drugs from reaching the brain or central nervous system.

In the clinical trial, Insightec plans to test its MRI-guided ultrasound technology for briefly penetrating the blood-brain barrier to allow drug treatments to pass through. The company uses MRI scans to provide imaging and temperature measurements as guides to find specific tissue targets, where focused ultrasound waves ablate, or break-up and dissipate, the target tissue.

Insightec devised a version of its technology for neurological conditions called Exablate Neuro, which will be tested for safety and feasibility in the clinical trial. Up to 15 individuals diagnosed with signs of glioblastoma, and scheduled for surgical removal of their tumors, will receive an ultrasound tracer solution in the form of microbubbles in their blood streams. Ultrasound will then be directed to the tracer solution in their brains to vibrate the microbubbles and cause a temporary disruption in the blood-brain barrier.

Exablate Neuro is already approved by FDA for treating some neurological disorders. As reported by Science & Enterprise in July 2016, FDA cleared Exablate Neuro as a treatment for essential tremors, a neurological disorder marked by involuntary shaking of the hands or other parts of the body, who do not respond to drug treatments.

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