RecruitingPhase 1Phase 2NCT05615623

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

A Safety and Feasibility Study to Evaluate Blood Brain Barrier Disruption Using Exablate MR Guided Focused Ultrasound in Combination With Doxorubicin in Treating Pediatric Patients With Diffuse Intrinsic Pontine Gliomas (DIPG)


Sponsor

InSightec

Enrollment

10 participants

Start Date

Jan 4, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using focused ultrasound to temporarily open the blood-brain barrier — the protective wall around the brain — can help the chemotherapy drug doxorubicin reach brain tumors more effectively in children with a type of inoperable brainstem cancer called DIPG. **You may be eligible if...** - You are between 5 and 18 years old - You have been diagnosed with DIPG (diffuse intrinsic pontine glioma), a type of brainstem tumor - You finished radiation therapy 4–12 weeks ago - Your recent brain scan does not show signs of tissue death or bleeding - Your life expectancy is at least 6 months - You (or a parent/guardian) are able and willing to give consent **You may NOT be eligible if...** - You have a brain or body infection - You have already received the maximum safe dose of certain chemotherapy drugs (anthracyclines) - You have HIV or another immune-suppressing condition - You have active seizures that are not controlled by medication - You are allergic to the ultrasound contrast agent or to gadolinium (MRI dye) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExablate

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

DRUGDoxorubicin

Doxorubicin infusion


Locations(1)

Sunnybrook Research Institute

Toronto, Ontario, Canada

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NCT05615623


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