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

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.

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>

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