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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

Summary

This trial will test a new way to do a liquid biopsy on brain tumors to see if it is safe and effective.

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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Correlation with Tumor Tissue

Secondary outcome measures

Circulating Free DNA

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

0 / 22Eligibility criteria met

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor

89 Previous Clinical Trials

3,657 Total Patients Enrolled

7 Trials studying Glioblastoma

101 Patients Enrolled for Glioblastoma

Media Library

Exablate Model 4000 (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05383872 — N/A

Glioblastoma Research Study Groups: Exablate BBBD

Glioblastoma 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

~8 spots leftby Dec 2024

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