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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
Timeline
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 belowSelect...
I am mostly able to care for myself but may not be able to do active work.
Select...
My brain scans show a tumor that can be targeted with precise radiation.
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
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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not controlled even with medication.I do not have an active drug or alcohol disorder that increases my risk for seizures, infections, or poor decision-making.I am mostly able to care for myself but may not be able to do active work.My heart failure is getting worse or not stable.I cannot stop taking my blood thinner medication as per my doctor's advice.I am between 18 and 80 years old and can consent to treatment.I have more than one seizure per week despite taking medication.I have chest pain that isn't controlled by medication.I had a heart attack within the last six months.My kidney function is low, with a filtration rate under 30 mL/min.I have a brain blood vessel problem like an aneurysm or clot.I have an active or chronic infection or inflammation, confirmed by MRI or clinical findings.I am HIV positive.My brain scans show a tumor that can be targeted with precise radiation.I am scheduled for surgery or a biopsy on my tumor within the next 4 weeks.I have severe lung problems or serious allergies that make using Definity risky.I do not have infections that could cause brain swelling or abscesses.I have a history of liver disease or bleeding disorders.My tumor is located in the deep central part of my brain.I have cancer in more than one spot.My tumor cannot be fully treated with ultrasound due to its size or location.I do not have serious heart disease or unstable blood pressure and heart rate.I have a known blood vessel disorder in my brain or body.I cannot lie on my back still for 3 hours or I am claustrophobic.I don't have any current or past bleeding in my brain.I have had a serious irregular heartbeat.
Research Study Groups:
This trial has the following groups:- Group 1: Exablate BBBD
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.
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
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