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Clinical Trials in Canada / NCT05615623
Active, not recruiting Phase 1/2

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG

NCT05615623 · tracked via the Priya Life Science Canada tracker
Sponsor
Phase
Phase 1/2
Started
2023-01-04
Last updated
2026-04-21

Condition(s) studied

Brain Tumor

Investigational drug(s) / intervention(s)

ExablateDoxorubicin →

Exablate: Blood Brain Barrier Disruption (BBBD) via Exablate Type 2 system with microbubble resonators on the day of Doxorubicin infusion to treat DIPG brain tumors

Doxorubicin: Doxorubicin infusion

Study summary

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients

Eligibility

Sex
ALL
Min age
5 Years
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sunnybrook Research Institute Toronto Ontario

More InSightec trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05615623 on ClinicalTrials.gov ↗ ← All trials in Canada