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Focused Ultrasound for Brain Tumor

Waitlist Available
Led By Graeme Woodworth, MD
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky rating 70-100
Men or women age between 18 and 80 years, inclusive
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, approximately 12 months.
Awards & highlights

Study Summary

This trial is testing whether a device that disrupts the blood brain barrier is safe for patients with a certain type of brain tumor.

Who is the study for?
This trial is for adults aged 18-80 with a high-grade brain tumor called glioblastoma, who've finished radiation and chemo treatment. They must be able to communicate during the procedure, have a life expectancy of at least 3 months, and not have any severe health issues or conditions that could interfere with MRI scans.Check my eligibility
What is being tested?
The study tests the safety of using ExAblate Model 4000 Type 2 Focused Ultrasound (FUS) to temporarily disrupt the blood-brain barrier in patients receiving standard care for glioblastoma. This disruption may help treatments reach the brain more effectively.See study design
What are the potential side effects?
Potential side effects include discomfort from lying still during long MRI sessions, reactions to contrast agents used in imaging if sensitive, and risks associated with disrupting the blood-brain barrier such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am mostly able to care for myself and carry out normal activities.
I am between 18 and 80 years old.
I have been diagnosed with a Grade IV brain tumor (GBM).
I have completed the standard radiation and TMZ treatment.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 12 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device and procedure related adverse events
Secondary outcome measures
Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging

Trial Design

1Treatment groups
Experimental Treatment
Group I: Focused Ultrasound (FUS)Experimental Treatment1 Intervention
The ExAblate Model 4000 Type 2 system is intended for use as a tool to induce localized and temporary blood-brain barrier disruption in patients with glioblastoma undergoing initial standard of care chemotherapy.
First Studied
Drug Approval Stage
How many patients have taken this drug
Focused ultrasound (FUS)

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor
88 Previous Clinical Trials
3,684 Total Patients Enrolled
7 Trials studying Glioblastoma
138 Patients Enrolled for Glioblastoma
Graeme Woodworth, MDPrincipal InvestigatorUniversity of Maryland
2 Previous Clinical Trials
135 Total Patients Enrolled

Media Library

Focused ultrasound (FUS) Clinical Trial Eligibility Overview. Trial Name: NCT03551249 — N/A
Glioblastoma Research Study Groups: Focused Ultrasound (FUS)
Glioblastoma Clinical Trial 2023: Focused ultrasound (FUS) Highlights & Side Effects. Trial Name: NCT03551249 — N/A
Focused ultrasound (FUS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03551249 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for this research project preclude senior citizens?

"According to the eligibility requirements listed on this clinical trial, applicants must be between 18 and 80 years old. There are 147 studies specifically for people under the age of 18 and 596 studies for patients over 65."

Answered by AI

How many research facilities are coordinating this trial?

"Some of the 4 other locations where this trial is taking place include the University of Maryland in Baltimore, Maryland, West virginia University in Morgantown, West Virginia, and Brigham and Women's Hospital in Boston, Massachusetts."

Answered by AI

If I decide to participate in this research, what would my role be?

"20 patients that have glioma and meet the following additional conditions are needed for this study: being a man or woman aged 18 to 80, having a Karnofsky rating of 70 to 100, being able to attend all study visits, being able to communicate during the ExAblate BBBD procedure."

Answered by AI
~3 spots leftby Apr 2025