BRAINFUL (BRAIN Tumor Focused Ultrasound-enabled Liquid Biopsy) Trial
Brain Neoplasms | Liquid BiopsyBackground:
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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
18 and up
Participation Criteria
Inclusion Criteria:
* New MRI-diagnosed intracranial lesions that are suitable to biopsy surgically
* The lesion to be treated is clearly defined and can be well distinguished from surrounding brain tissue.
* Male or female aged 18 years or older
* Capable of providing informed consent and complying with study procedures, including tolerability in the supine position and MRI examination without significant claustrophobia, and acceptance of surgery (open or stereotactic) after HIFU treatment.
* Able to communicate during the ExAblate® MRgFUS procedure.
* Karnofsky rating 70-100
Exclusion Criteria:
* If region of treatment locates in \< 1.0 cm from the inner table of the skull, on skull base or in the posterior fossa
* Presence of hydrocephalus, severe vomiting, intractable headache or decreased level of consciousness due to increased intracranial pressure
* Unable to complete high-density CT and MRI studies of the head at the any other MRI contraindication, such as:
* Large body habitus and not fitting comfortably into the scanner
* Difficulty lying supine and still for up to 2 in the MRI unit or significant claustrophobia
* 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
Study Location
Toronto Western Hospital, University Health Network
Toronto Western Hospital, University Health NetworkToronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- University Health Network, Toronto
- Participants Required
- More Information
- Study ID:
NCT04940507