Focused Ultrasound for Brain Cancer
(BRAINFUL Trial)
Trial Summary
What is the purpose of this trial?
Background: Accessing brain tumor material for pathological diagnosis requires invasive procedures that carry risk to patients including brain hemorrhages and death. Liquid biopsies are emerging non-invasive alternatives to direct tumour biopsies but the abundance of circulating tumor DNA (ctDNA) is relatively low and this limits our ability to accurately make the molecular diagnosis of brain tumors. We have recently shown promising results that suggest that the analysis of blood samples can distinguish brain tumor types. We now want to couple liquid biopsies with high intensity focused ultrasound (HIFU) to enhance the release of tumor DNA into the circulation and increase the sensitivity/and specificity of liquid biopsies for brain tumors. The aim of this project is to build on our preliminary findings and investigate the the time dependent changes associated with HIFU of a tumor to see if it improves accuracy of diagnosis and specifically molecular subtyping of tumors based on peripheral blood and cerebrospinal fluid (CSF) circulating tumor derived markers following HIFU.
Will I have to stop taking my current medications?
If you are taking medications that increase bleeding risk, such as aspirin, antiplatelet medications, or anticoagulants, you will need to stop them for a specific period before treatment. For example, aspirin should be stopped 7 days prior, and certain anticoagulants should be stopped 48 to 72 hours before treatment.
What data supports the effectiveness of the treatment Magnetic Resonance Guided Focused Ultrasound for brain cancer?
Research shows that Magnetic Resonance Guided Focused Ultrasound (MRgFUS) is a promising noninvasive treatment that can precisely target and destroy brain tumors by focusing ultrasound energy, and it has been used successfully in treating other conditions like bone metastases and uterine fibroids. It also helps in delivering chemotherapy drugs more effectively to brain tumors by temporarily opening the blood-brain barrier.12345
Is focused ultrasound generally safe for use in humans?
Focused ultrasound, guided by MRI, is a noninvasive technique that has been used safely in humans for various conditions, including breast cancer and brain disorders. Studies have shown it can be used without opening the skull, and it has been tested in both animal models and human trials, demonstrating its safety and feasibility.12367
How is the treatment Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition different from other brain cancer treatments?
Research Team
Gelareh Zadeh, MD, PhD
Principal Investigator
University of Toronto
Andres M. Lozano, MD, PhD
Principal Investigator
University of Toronto
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
MRgFUS Procedure
Participants undergo MRgFUS to enhance the release of tumor DNA into circulation
Post-MRgFUS Monitoring
Blood and CSF samples are collected at several timepoints to measure cfDNA levels
Surgery and Post-Surgery Monitoring
Standard of care tumor biopsy/excision followed by blood sample collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Magnetic Resonance Guided Focused Ultrasound Thalamotomy
- Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition
Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition is already approved in United States, European Union, Canada for the following indications:
- Glioblastoma brain tumors
- Glioblastoma brain tumors
- Glioblastoma brain tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Canadian Cancer Society (CCS)
Collaborator
Brain Canada
Collaborator