Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG
Brain Tumor
About this trial
This is an interventional device feasibility trial for Brain Tumor focused on measuring DIPG, Focused Utrasound, Chemotherapy, Phase I trial, Pediatrics
Eligibility Criteria
Inclusion Criteria: Age between 5 and 18 years, inclusive Patient diagnosed with DIPG At least 4-week and not greater than 12 weeks from completion of radiation therapy Post-radiation imaging does not show evidence of necrosis/ hemorrhage or other features that contraindicate MRgFUS Able to attend all study visits and with life expectancy of at least 6 months Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so If on steroids, stable or decreasing dose for at least 7 days prior to study entry If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable Exclusion Criteria: Evidence of cranial or systemic infection Known life-threatening systemic disease Previous treatment with complete cumulative doses of Doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenediones Contraindication to Doxorubicin. - Known sensitivity to DEFINITY® ultrasound contrast agent or known hypersensitivity to perflutren microsphere or its components, e.g., polyethylene glycol. - Known sensitivity to gadolinium-based contrast agents Active seizure disorder or epilepsy (seizures despite medical treatment) for a minimum of 4 weeks prior to first cycle/Exablate BBBD procedure captured by history Patients with positive HIV status. - Immunosuppression (corticosteroids to prevent/treat brain edema are permitted) Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis Hypertension per age History of a bleeding disorder, coagulopathy or with a history of spontaneous tumour hemorrhage Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs [NSAIDs], statins) within washout period prior to treatment Patient receiving bevacizumab (Avastin) therapy or increasing doses of steroids Symptoms and signs of increased intracranial pressure Previous participation in other chemotherapy, molecularly targeted therapy or immunotherapy treatment-related phase 1 or 2 trials Tumor not visible on any pre-therapy or post-radiation imaging
Sites / Locations
- Sunnybrook Research InstituteRecruiting
Arms of the Study
Arm 1
Experimental
Blood Brain Barrier Disruption (BBBD)
Exablate MR Guided Focused Ultrasound for Blood Brain Barrier Disruption with Doxorubicin for treating pediatric patients with DIPG