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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
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
BRAINFUL Trial 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.Check my eligibility
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.See study design
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.
BRAINFUL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can communicate during the MRgFUS procedure.
Select...
I am mostly able to care for myself and carry out normal activities.
Select...
I have new brain lesions that can be biopsied.
BRAINFUL Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood and CSF levels of the circulating free DNA
Secondary outcome measures
Epigenomic analysis
Genomic analysis
Safety (procedure-related complications)
+1 moreBRAINFUL 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
1,475 Previous Clinical Trials
485,040 Total Patients Enrolled
Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,695 Total Patients Enrolled
Brain CanadaOTHER
18 Previous Clinical Trials
5,988 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been recruited to participate in this research project?
"That is accurate. The clinical trial in question, which was first announced on June 10th 2021, is currently looking for 50 individuals to take part in the study at a single site."
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