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RECRUITING
NCT05615623
PHASE1/PHASE2

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

Sponsor: InSightec

View on ClinicalTrials.gov

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

Official title: 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)

Key Details

Gender

All

Age Range

5 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-01-04

Completion Date

2026-07

Last Updated

2025-04-30

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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

DRUG

Doxorubicin

Doxorubicin infusion

Locations (1)

Sunnybrook Research Institute

Toronto, Ontario, Canada