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Focused Ultrasound

Focused Ultrasound BBBD for Glioblastoma

N/A
Recruiting
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Score >70
Subjects with stereotactically-targetable suspected glioblastoma tumor on pre-operative brain imaging scans
Must not have
Uncontrolled hypertension (systolic > 180 and diastolic BP > 120 on medication)
Active drug or alcohol disorder which have a higher risk for seizures, infection and/or poor executive functioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of using the Exablate device to temporarily open the blood-brain barrier in patients with suspected Glioblastoma. By doing this, doctors can collect fluid from the brain to check for cancer cells. The study will take place at up to 25 centers in the US.

Who is the study for?
Adults aged 18-80 with suspected glioblastoma brain tumors that can be targeted for surgery or biopsy are eligible. They must have a good performance status (Karnofsky Score >70) and be able to communicate during the procedure. Excluded are those with deep midline or multifocal tumors, certain heart conditions, uncontrolled hypertension, bleeding disorders, severe allergies, active infections including HIV, substance abuse issues, unstable mental health conditions at risk of suicide, and pregnant or breastfeeding women.
What is being tested?
The trial is testing the safety and effectiveness of using Focused Ultrasound (Exablate Model 4000) to temporarily disrupt the blood-brain barrier in patients with suspected glioblastoma. This disruption aims to facilitate liquid biopsy—a less invasive method for analyzing tumor tissue.
What are the potential side effects?
Potential side effects may include discomfort from lying still during treatment; reactions related to ultrasound exposure such as headaches or seizures; allergic reactions to contrast agents used in imaging; and risks associated with disrupting the blood-brain barrier like infection or inflammation.

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 but may not be able to do active work.
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My brain scans show a tumor that can be targeted with precise radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure is not controlled even with medication.
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I do not have an active drug or alcohol disorder that increases my risk for seizures, infections, or poor decision-making.
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My heart failure is getting worse or not stable.
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I cannot stop taking my blood thinner medication as per my doctor's advice.
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I have more than one seizure per week despite taking medication.
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I have chest pain that isn't controlled by medication.
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I had a heart attack within the last six months.
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My kidney function is low, with a filtration rate under 30 mL/min.
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I have a brain blood vessel problem like an aneurysm or clot.
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I have an active or chronic infection or inflammation, confirmed by MRI or clinical findings.
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I am HIV positive.
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I do not have infections that could cause brain swelling or abscesses.
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I have a history of liver disease or bleeding disorders.
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My tumor is located in the deep central part of my brain.
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I have cancer in more than one spot.
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I do not have serious heart disease or unstable blood pressure and heart rate.
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I have a known blood vessel disorder in my brain or body.
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I cannot lie on my back still for 3 hours or I am claustrophobic.
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I don't have any current or past bleeding in my brain.
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I have had a serious irregular heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Correlation with Tumor Tissue
Secondary study objectives
Circulating Free DNA

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Exablate BBBDExperimental Treatment1 Intervention
Using Exablate Model 4000 Type 2 for liquid biopsy in subjects with Glioblastoma

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor
91 Previous Clinical Trials
3,741 Total Patients Enrolled

Media Library

Exablate Model 4000 (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05383872 — N/A
Solid Tumors Research Study Groups: Exablate BBBD
Solid Tumors Clinical Trial 2023: Exablate Model 4000 Highlights & Side Effects. Trial Name: NCT05383872 — N/A
Exablate Model 4000 (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05383872 — N/A
~17 spots leftby Dec 2025
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