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Focused Ultrasound BBB Disruption for Glioblastoma

Waitlist Available
Led By Nir Lipsman, MD
Research Sponsored by InSightec
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up at each standard of care neuro-oncology follow up visit until date of death from any cause, assessed up to 48 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing whether it's safe to break down the blood-brain barrier in people with glioblastoma who have had surgery and standard chemotherapy.

Who is the study for?
Adults aged 18-80 with a confirmed diagnosis of Grade IV glioblastoma, who have completed initial surgery and chemo-radiation without complications. Participants must be ready for maintenance chemotherapy, have a life expectancy of at least 3 months, good functional status (Karnofsky rating 70-100), stable health (ASA score 1-3), and able to communicate during the procedure.Check my eligibility
What is being tested?
The trial is testing the safety of using Focused Ultrasound to disrupt the blood-brain barrier in patients with glioblastoma post-surgery and standard treatment. The goal is to see if this can safely be done before they start maintenance chemotherapy.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during the procedure, reactions to MRI contrast agents like gadolinium-DTPA or DEFINITY ultrasound contrast agent, and risks associated with disruption of the blood-brain barrier which could lead to brain swelling or other neurological issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Both men and women can participate.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at each standard of care neuro-oncology follow up visit until date of death from any cause, assessed up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at each standard of care neuro-oncology follow up visit until date of death from any cause, assessed up to 48 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
Interventional procedure
Secondary outcome measures
Effectiveness of BBB disruption in the treated tumor region
Feasibility of repeated BBB disruption will be evaluated through assessment of post-procedure contrast-enhanced magnetic resonance (MR) imaging

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: Focused Ultrasound (FUS) BBB DisruptionExperimental 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 standard of care chemotherapy.
First Studied
Drug Approval Stage
How many patients have taken this drug
Focused Ultrasound (FUS) BBB Disruption

Find a Location

Who is running the clinical trial?

InSightecLead Sponsor
87 Previous Clinical Trials
3,567 Total Patients Enrolled
7 Trials studying Glioblastoma
145 Patients Enrolled for Glioblastoma
Nir Lipsman, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Focused Ultrasound (FUS) BBB Disruption Clinical Trial Eligibility Overview. Trial Name: NCT03616860 — N/A
Glioblastoma Research Study Groups: Focused Ultrasound (FUS) BBB Disruption
Glioblastoma Clinical Trial 2023: Focused Ultrasound (FUS) BBB Disruption Highlights & Side Effects. Trial Name: NCT03616860 — N/A
Focused Ultrasound (FUS) BBB Disruption 2023 Treatment Timeline for Medical Study. Trial Name: NCT03616860 — N/A

Frequently Asked Questions

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

Does this experiment accept participants in the below-fifty age bracket?

"According to the terms of this scientific study, only individuals between 18 and 80 are eligible for enrollment. Conversely, 34 clinical trials exist specifically for those under 18 years old while 414 studies apply to seniors over 65."

Answered by AI

Is enrollment currently available for this research endeavor?

"Information published on clinicaltrials.gov displays that this specific trial, which was first made available to the public in October 2018 and most recently updated in March 2022 is not currently recruiting participants. While it does not need volunteers presently, there are 440 other medical studies actively seeking individuals right now."

Answered by AI

What criteria must patients meet in order to participate in this medical research?

"To be considered for this glioblastoma trial, applicants must fall between the age of 18 and 80. A maximum of 14 candidates will be accepted."

Answered by AI
~2 spots leftby Feb 2025