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:
- 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
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?
Description
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
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