The University of Maryland School of Medicine recently announced that the first clinical trial of its kind in the United States will soon begin there. Researchers are investigating the use of focused ultrasound to disrupt the blood-brain barrier (BBB) in patients who are scheduled to undergo brain cancer surgery. The safety and feasibility study is a first step toward noninvasively treating these deadly cancers.
Led by neurosurgeon Graeme Woodworth, MD, the prospective, single-arm, non-randomized, open-label feasibility study will evaluate the safety of focal BBB disruption using Insightec’s Exablate system in up to 15 patients with suspected glioblastoma who are scheduled to undergo brain tumor resection. Patients with non-enhancing tumor components in a non-eloquent region of the planned resection volume will be eligible. Interested parties should contact Charlene Aldrich at (410) 328-5332 or CALDRICH@smail.umaryland.edu.
Within a few months after the start of this study, University of Maryland researchers expect to begin a second FDA-approved clinical trial in which newly diagnosed glioblastoma patients would undergo BBB opening prior to treatment with standard chemotherapy, temozolomide. The ultrasound-augmented approach would target the areas where the tumor would be most likely to reoccur.
The U.S. Food and Drug Administration (FDA) approved the clinical trial in October 2017. Although there are similar research studies in Canada and other countries to disrupt the BBB using focused ultrasound, this was the first time the FDA approved a clinical study of this type in the US.
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