BT015 Safety and Effectiveness of Exablate to Mediate Blood-Brain Barrier Disruption (Glioblastoma)

What is the Purpose of this Study?

We are doing this study to evaluate the safety and effectiveness of an experimental procedure using new technology called Exablate Model 4000 Type 2.0/2.1 for adults with glioblastoma brain tumors. We want to know what effects it has (good and bad) on biomarkers (an indicator of a condition or disease in the body) released into the bloodstream.

What is the Condition Being Studied?

Glioblastoma Multiforme

Who Can Participate in the Study?

Adults ages 18-80 who:

  • Have a stereotactically-targetable suspected glioblastoma tumor on pre-operative brain imaging scans
  • Do NOT have a tumor originating from the deep midline, thalamus, midbrain, cerebellum, or brainstem

For more information about who can be in this study, please contact the study team at 919-684-5301.

Age Group

What is Involved?

The study consists of a screening visit (up to 28 days prior to treatment), a single treatment visit, a 12-48 hour safety check, and a 4 week post-treatment follow up visit.

If you choose to join the study, you will:

  • Have physical exams
  • Have blood draws
  • Have imaging scans (CT and MRI)
  • Donate tissue from your standard of care surgical resection or biopsy to be analyzed and compared with the biomarkers detected in your blood samples

Study Details

Full Title
A Pivotal Study to Evaluate the Safety and Effectiveness of Exablate Model 4000 using Microbubble Resonators to Temporarily Mediate Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects with Glioblastoma Brain Tumors
Principal Investigator
Allan H. Friedman Distinguished Professor of Neurosurgery
Protocol Number
IRB: PRO00114869
NCT: NCT05383872
Phase III
Enrollment Status