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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

Must not have

Patients with cerebellar or brainstem tumors

History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study, approximately 12 months.

Awards & highlights

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is in the cerebellum or brainstem.

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I have a bleeding disorder or my tumor has bled on its own.

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I do not have serious heart problems or unstable blood pressure.

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I cannot lie on my back for long or I am claustrophobic.

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I have had a recent brain bleed.

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I experience symptoms like headaches, nausea, or vomiting that suggest increased pressure in my brain.

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I have a cardiac shunt.

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My kidneys do not work well or I am on dialysis.

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My blood pressure is very high even with medication.

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My depression is severe and not well-managed by medication, with a risk of suicide.

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I am currently receiving Avastin therapy.

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I am taking more than 24 mg of dexamethasone daily.

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I have a blood vessel disorder in my brain or body, such as a clot, malformation, aneurysm, or inflammation.

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I have seizures that aren't controlled by medication.

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I am allergic to DEFINITY® or perflutren.

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I do not have any infections in my brain or body.

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I have severe liver problems, like cirrhosis or active hepatitis.

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.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focused ultrasound (FUS)

2019

N/A

~20

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor

89 Previous Clinical Trials

3,694 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

~3 spots leftby Jul 2025

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