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Focused Ultrasound BBB Disruption for Glioblastoma
N/A
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
Be older than 18 years old
Timeline
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
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.
Timeline
Screening ~ 3 weeks3 visits
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
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
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Focused Ultrasound (FUS) BBB Disruption
2018
N/A
~20
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Who is running the clinical trial?
InSightecLead Sponsor
89 Previous Clinical Trials
3,700 Total Patients Enrolled
7 Trials studying Glioblastoma
144 Patients Enrolled for Glioblastoma
Nir Lipsman, MDPrincipal InvestigatorSunnybrook Health Sciences Centre
2 Previous Clinical Trials
60 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have trouble lying down and staying still for up to 4 hours in a small space, like an MRI machine, or you feel very anxious in small spaces.You have a serious, life-threatening disease.You have a heart condition that causes blood to flow abnormally.You need higher and higher doses of corticosteroids.You have a condition affecting the blood vessels in your brain or body.You are allergic to DEFINITY ultrasound contrast agent or perflutren.You have long-term lung problems.You are receiving other treatments like chemotherapy, gene therapy, or radiation therapy in addition to this clinical trial.You are taking blood thinners or other medications that increase the risk of bleeding within a certain period before starting the treatment.You have symptoms like a severe headache, feeling sick to your stomach, throwing up, feeling tired, and swelling in the back of your eye.Both men and women can participate.You have a history of severe allergic reactions or multiple allergies, including drug allergies, asthma, or hay fever.You have an infection in your head or throughout your body.You have a history of bleeding disorder or blood clotting problems, or you have experienced spontaneous bleeding from a tumor in the past.You have sleep apnea that is not being treated or controlled.You have already completed a full course of chemotherapy in the past.You are allergic to eggs or products made from eggs.You have experienced a mini-stroke (TIA) within the past month.
Research Study Groups:
This trial has the following groups:- Group 1: Focused Ultrasound (FUS) BBB Disruption
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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