Within a few months, University of Maryland researchers expect to open another FDA-approved clinical trial in which newly diagnosed glioblastoma patients will undergo blood-brain barrier opening prior to treatment with standard chemotherapy, temozolomide. This new ultrasound-augmented approach would target the areas where tumor recurrence would be most likely to occur.

Nearly 80,000 people are diagnosed with a primary brain tumor each year; 26,000 of these tumors are malignant. Glioblastoma is the most common type of brain cancer and the most deadly. Patients live an average of 15 months after diagnosis; the average five-year survival is only 5.5 percent.


"Glioblastoma is the most aggressive and lethal type of brain tumor, but treatment has been severely limited by our inability to get chemotherapy and other therapeutics through the blood-brain barrier," says Kevin J. Cullen, MD, the Marlene and Stewart Greenebaum Distinguished Professor in Oncology at UMSOM and director of the UMGCCC. "Dr. Woodworth's study is an important first step in finding an effective way to administer drug therapies that would improve patients' quality of life and increase their survival."

In the initial study, researchers plan to enroll up to 15 patients with suspected glioblastoma, an aggressive brain cancer, who will undergo surgery at UMMC to remove their tumor.

The morning of the scheduled surgery, patients will undergo a standard magnetic resonance imaging (MRI) scan as part of the preoperative planning process. Guided by this MRI, doctors will target a precise region within the tumor with ultrasound, while the injected microbubbles are circulating within the bloodstream. The microbubbles will oscillate within the ultrasound field, causing temporary openings in the walls of the brain blood vessels, and allowing the MRI contrast agent, gadolinium, to pass into the brain tissue. The MRI scan will then be completed, documenting the extent to which the blood-brain barrier was disrupted.

The data from the MRI will be used in a system called intraoperative stereotactic neuro-navigation - an advanced 3D-guidance system that accurately localizes the tumor within the brain. After the surgery, researchers will also rigorously examine the tissue that was removed to study the potential therapeutic and other effects from the focused ultrasound procedure.

In this initial trial, the increased amount of contrast enhancement within the tumor provided by the focused ultrasound procedure may help the 3D navigation during the surgery, according to Dr. Woodworth. "The standard of care is not changing in regard to the surgical procedure. We are functionally increasing the amount of navigation data available to the surgeon," he says.

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