Procedure : Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition
Dr. Andres Lozano
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 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