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Procedure
Focused Ultrasound for Brain Cancer (BRAINFUL Trial)
N/A
Recruiting
Led By Andres M. Lozano, MD, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to communicate during the ExAblate® MRgFUS procedure
Karnofsky rating 70-100
Must not have
MRI findings: Active infection/inflammation, Acute or chronic brain haemorrhages, Moderate/severe brain edema or midline shift >15 mm, Clips or other metallic implanted objects in the skull or the brain, except shunts, Significant cardiac disease or unstable hemodynamic status, On medications that increase the bleeding risk, specifically: a) aspirin or another antiplatelet medication (clopidogrel, prasugrel, ticlopidine, abciximab) for the last 7 days prior to treatment; b) oral, subcutaneous or intravenous anticoagulant medications, such as oral vitamin K inhibitors for the last 7 days, non-vitamin K inhibitor oral anticoagulant (dabigatran, apixaban, rivaroxaban) for the last 72 hours, and intravenous or subcutaneous heparin-derived compounds for the last 48 hours, Abnormal coagulation profile, specifically: platelet <100,000/μl, Prothrombin Time >14 seconds, activated partial thromboplastin time (aPTT) >36 seconds, and INR > 1.3, Unqualified fit for the anaesthesia by an anesthesiologist assessment, ASA IV-V, Currently in a clinical trial involving an investigational product or non-approved use of a drug or device, Pregnant and lactating women
If region of treatment locates in < 1.0 cm from the inner table of the skull, on skull base or in the posterior fossa
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-mrgfus: within 1 hour; post-mrgfus: within 1 hour, between 3-4 hours; pre-surgery: within 1 hour; post-surgery:within 1 hour, between 16-24 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating whether using high intensity focused ultrasound (HIFU) to break up brain tumors can improve the accuracy of liquid biopsies for brain tumors.
Who is the study for?
Adults over 18 with new MRI-diagnosed brain tumors suitable for biopsy can join this trial. They must be able to give consent, handle lying down in an MRI without severe claustrophobia, and accept surgery post-treatment. A good performance status (Karnofsky rating 70-100) is required.
What is being tested?
The BRAINFUL trial tests if using high-intensity focused ultrasound (HIFU) alongside liquid biopsies improves the accuracy of diagnosing brain tumors by enhancing tumor DNA release into blood/CSF.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from lying still during procedures, risks associated with MRIs and ultrasounds like heating or pressure on tissue, and typical surgical risks post-HIFU.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can communicate during the MRgFUS procedure.
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I am mostly able to care for myself and carry out normal activities.
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I have new brain lesions that can be biopsied.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My treatment area is near the skull's inner layer or base.
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I have severe symptoms like intense headaches or vomiting due to high pressure in my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-mrgfus: within 1 hour; post-mrgfus: within 1 hour, between 3-4 hours; pre-surgery: within 1 hour; post-surgery:within 1 hour, between 16-24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-mrgfus: within 1 hour; post-mrgfus: within 1 hour, between 3-4 hours; pre-surgery: within 1 hour; post-surgery:within 1 hour, between 16-24 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood and CSF levels of the circulating free DNA
Secondary study objectives
Epigenomic analysis
Genomic analysis
Safety (procedure-related complications)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Tumor cohortExperimental Treatment1 Intervention
Intervention 1:
Participants will undergo a partial tumor ablation with MRgFUS using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel). Blood and CSF samples will be drawn on several timepoints before and after the procedure.
Intervention 2:
Participants will undergo a standard of care tumor biopsy/excision one day after the "Intervention 1". Blood samples will be drawn on several timepoints before and after the procedure.
Group II: Essential tremor cohortExperimental Treatment1 Intervention
To identify the levels of circulating free DNA release after MRgFUS procedure in non-tumoral patients and to check whether the MRgFUS procedure induce tumoral mutations itself, we will draw blood samples from essential tremor patients before and after standard of care MRgFUS thalamotomy procedure.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,531 Previous Clinical Trials
504,272 Total Patients Enrolled
Canadian Cancer Society (CCS)OTHER
82 Previous Clinical Trials
41,675 Total Patients Enrolled
Brain CanadaOTHER
20 Previous Clinical Trials
5,942 Total Patients Enrolled
Andres M. Lozano, MD, PhDPrincipal InvestigatorUniversity of Toronto
Gelareh Zadeh, MD, PhDPrincipal InvestigatorUniversity of Toronto
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can communicate during the MRgFUS procedure.I can sign consent, follow study rules, lie flat for MRI without severe claustrophobia, and agree to surgery after HIFU.I am mostly able to care for myself and carry out normal activities.My treatment area is near the skull's inner layer or base.I am 18 years old or older.I have severe symptoms like intense headaches or vomiting due to high pressure in my brain.I have new brain lesions that can be biopsied.
Research Study Groups:
This trial has the following groups:- Group 1: Essential tremor cohort
- Group 2: Tumor cohort
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.