Baltimore, Md., Aug. 9, 2018 - In the first such clinical trial in the United States, physician-scientists with the University of Maryland School of Medicine (UMSOM) are investigating the use of MRI-guided focused ultrasound to open the blood-brain barrier. The trial will be conducted with patients undergoing brain cancer surgery at the University of Maryland Medical Center (UMMC).

The blood-brain barrier is a specialized network of vascular and brain cells that acts as the brain's security system, helping to safeguard the brain and regulate the flow of substances into and out of it. While this network protects the brain, it also limits doctors' ability to deliver effective doses of disease-fighting drugs to the brain, particularly in the case of brain tumors, which are notoriously treatment-resistant. This safety and feasibility study is a first step in attempting to overcome a major hurdle in treating these often-deadly cancers.

"The ability to temporarily disrupt the blood-brain barrier without causing tissue damage has the potential to dramatically alter the landscape of drug delivery to the brain for many diseases," says the principal investigator, Graeme F. Woodworth, MD, professor of neurosurgery at UMSOM and director of the Brain Tumor Treatment and Research Center at the University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC) at UMMC.
"If successful, this approach would allow us to use chemotherapy and other therapies in the brain in ways that are currently not possible," says Dr. Woodworth, noting that 98 percent of currently approved drugs don't enter the brain because of the blood-brain barrier. "If we can selectively open the blood-brain barrier, then in the future we could give a much lower dose of powerful drugs, which would likely reduce toxic side effects and make treatments safer and more effective for patients."

The process involves injecting microscopic inert gas-filled bubbles into a patient's bloodstream and then oscillating the microbubbles (causing them to move back and forth) with highly targeted sound waves, stretching the blood vessel walls to create temporary openings.

The U.S. Food and Drug Administration (FDA) approved the clinical trial in October 2017 after a lengthy review process. Although there are similar research studies in Canada and other countries, this was the first time the FDA approved a clinical study using this promising technology and approach.

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