Clinical Trial to Disrupt the Blood-brain Barrier for Brain Tumor Treatment Launched at University of Maryland

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.


woodworth video still playLed 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 .

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. 

See the University of Maryland Press Release >
See an Investigator Profile of Dr. Graeme Woodworth >
See Video of Dr. Woodworth describing the study >

Media Coverage

Aunt Minnie | FDA Approves Focused US Blood-brain Barrier Study 8/10/18
Radiology Business | Historic Clinical Trial to Focus on Use of MRI-guided Focused Ultrasound to Open Blood-brain Barrier 8/10/18
Medical Xpress | First FDA-approved Study of Focused Ultrasound to Open Blood-brain Barrier 8/9/18