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.
Who Can Participate?
Eligibility
Adults ages 18-80 who:
<ul>
<li> Have a stereotactically-targetable suspected glioblastoma tumor on pre-operative brain imaging scans</li>
<li> Do NOT have a tumor originating from the deep midline, thalamus, midbrain, cerebellum, or brainstem</li></ul>
For more information about who can be in this study, please contact the study team at 919-684-5301.
<ul>
<li> Have a stereotactically-targetable suspected glioblastoma tumor on pre-operative brain imaging scans</li>
<li> Do NOT have a tumor originating from the deep midline, thalamus, midbrain, cerebellum, or brainstem</li></ul>
For more information about who can be in this study, please contact the study team at 919-684-5301.
Age Range
18-80
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
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:
<ul>
<li> Have physical exams</li>
<li> Have blood draws</li>
<li> Have imaging scans (CT and MRI) </li>
<li> Donate tissue from your standard of care surgical resection or biopsy to be analyzed and compared with the biomarkers detected in your blood samples</li></ul>
If you choose to join the study, you will:
<ul>
<li> Have physical exams</li>
<li> Have blood draws</li>
<li> Have imaging scans (CT and MRI) </li>
<li> Donate tissue from your standard of care surgical resection or biopsy to be analyzed and compared with the biomarkers detected in your blood samples</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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
Gerald
Grant
Protocol Number
PRO00114869
NCT ID
NCT05383872
Phase
III
Enrollment Status
Open to Enrollment