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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 more

Awards & 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.

0 / 6Eligibility criteria met