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Focused Ultrasound

Focused Ultrasound BBBD for Glioblastoma

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
Screening 3 weeks
Treatment Varies
Follow Up through study completion, up to 1 year
Awards & highlights

Study 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
I am mostly able to care for myself but may not be able to do active work.
My brain scans show a tumor that can be targeted with precise radiation.


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

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

Frequently Asked Questions

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

Do I satisfy the criteria to take part in this research endeavor?

"This medical trial seeks 57 subjects of both genders, aged between 18 and 80. Patients must possess the capacity to provide informed consent, be scheduled for a surgical intervention within one month's time, demonstrate cognitive aptitude during Exablate BBBD treatments, display features indicative of glioblastoma on pre-operative brain scans, and have at least 70% performance according to Karnofsky criteria."

Answered by AI

How widely distributed is this clinical trial's implementation?

"At present, this trial is underway at 6 sites situated in cities such as New york, Miami and Baltimore. To reduce travel demands if you decide to join the study, it is preferable to choose a clinic that is closest to your home."

Answered by AI

Is there still an opportunity to register for participation in the trial?

"According to the clinicaltrials.gov website, this research is actively seeking participants. This medical trial was initially posted on August 8th 2022 and has seen its most recent update on October 24th 2022."

Answered by AI

Is the minimum age requirement for participants in this trial lower than 40 years old?

"Eligible participants of this clinical trial must be aged 18 or older, but below 80 years old."

Answered by AI

What is the aggregate amount of participants enrolled in this clinical trial?

"This study necessitates the recruitment of 57 suitable patients, who meet certain criteria. NYU Grossman School of Medicine in New york and Miami Cancer Institute at Baptist Health in Florida are two clinical trial sites where participants can enroll for this research."

Answered by AI
~13 spots leftby Dec 2024