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Focused Ultrasound for Brain Tumor
N/A
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
Timeline
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 belowSelect...
I am mostly able to care for myself and carry out normal activities.
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I am between 18 and 80 years old.
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I have been diagnosed with a Grade IV brain tumor (GBM).
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I have completed the standard radiation and TMZ treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout the study, approximately 12 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 12 months.
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focused ultrasound (FUS)
2019
N/A
~20
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the cerebellum or brainstem.I have a bleeding disorder or my tumor has bled on its own.I do not have serious heart problems or unstable blood pressure.I have seizures that aren't controlled by medication.I am between 18 and 80 years old.I cannot lie on my back for long or I am claustrophobic.I am not on blood thinners or medications that increase bleeding risk.I have had a recent brain bleed.I experience symptoms like headaches, nausea, or vomiting that suggest increased pressure in my brain.I have a cardiac shunt.I am currently receiving other specific treatments for my tumor.My kidneys do not work well or I am on dialysis.My blood pressure is very high even with medication.I am mostly able to care for myself and carry out normal activities.I have completed the standard radiation and TMZ treatment.My depression is severe and not well-managed by medication, with a risk of suicide.I am currently receiving Avastin therapy.I am taking more than 24 mg of dexamethasone daily.I am eligible for additional treatment with TMZ after my main treatment.I have a blood vessel disorder in my brain or body, such as a clot, malformation, aneurysm, or inflammation.I am allergic to DEFINITY® or perflutren.I do not have any infections in my brain or body.I have severe liver problems, like cirrhosis or active hepatitis.I have been diagnosed with a Grade IV brain tumor (GBM).
Research Study Groups:
This trial has the following groups:- Group 1: Focused Ultrasound (FUS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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