• A clinical trial is ongoing in Milan assessing focused ultrasound–induced blood-brain barrier (BBB) opening to delay or prevent brain tumor recurrence.
  • Researchers are disrupting the BBB in patients with glioblastoma who are undergoing maintenance chemotherapy.
  • Similar studies are ongoing in the US, Canada, and Korea.

Key Points

  • A clinical trial in Milan is assessing focused ultrasound–induced blood-brain barrier (BBB) opening to delay or prevent brain tumor recurrence.
  • Researchers are disrupting the BBB in patients with glioblastoma who are undergoing maintenance chemotherapy.
  • Similar studies are ongoing in the US, Canada, and Korea.

Prada BBB Maintenance study SMItaly is the latest hub of focused ultrasound research to offer a clinical trial aimed at delaying or preventing recurrence of glioblastoma (GBM).

GBMs are aggressive, malignant brain tumors. The current standard of care for these patients is surgery to remove the bulk of the tumor, followed by chemotherapy and radiation. Unfortunately, the prognosis is generally poor.

However, this early-stage clinical trial is using Insightec’s Exablate Neuro device to temporarily and reversibly open the blood-brain barrier (BBB) in patients with GBM after the initial removal of the tumor and while they are undergoing maintenance chemotherapy treatment.

The BBB is a protective layer of tightly joined cells that lines the blood vessels in the brain and prevents harmful substances, such as toxins and infectious agents, from diffusing into the surrounding brain tissue. It can also prevent therapeutic agents from getting into the brain, which is why research has centered on using focused ultrasound to safely and temporarily disrupt this barrier.

The trial is enrolling patients at the Istituto Neurologico C. Besta in Milan, Italy, where Francesco DiMeco, MD, Director of the Department of Neurosurgery, and Francesco Prada, MD, former Foundation research fellow and Director of the Acoustic Neuroimaging and Therapy Lab, are leading the study.

“We hope that disrupting the BBB for a short time will allow the chemotherapy to enter the brain at the tumor site in higher concentrations than would normally occur,” explains Dr. Prada. “If that is possible, then we would expect to see a slower recurrence of the tumor than is achieved without BBB opening.”

There are three similar clinical trials exploring focused ultrasound–induced BBB opening for GBM. One trial is taking place in the US at the University of Maryland, Brigham and Women’s Hospital, the University of Virginia, and West Virginia University. Two other trials are also underway at Sunnybrook Health Sciences Centre in Toronto and Severance Hospital, Yonsei University Health System in Korea.

“We are proud to join the other leading focused ultrasound researchers around the world in exploring this innovative technology to address such a devastating disease,” said Dr. Prada. “We hope that our results will add to the global body of knowledge and eventually be able to offer hope to these patients.”

To learn more about the Italian trial, please visit clinicaltrials.gov.

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