RecruitingPhase 1Phase 2NCT05630209

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (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 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric patients


Eligibility

Min Age: 5 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a focused ultrasound technique that temporarily opens the blood-brain barrier — the protective shield around the brain — to help deliver doxorubicin (a chemotherapy drug) more effectively into brain tumors. It is designed for children and young adults with DIPG (diffuse intrinsic pontine glioma), an extremely aggressive brainstem tumor. **You may be eligible if...** - You are between 5 and 21 years old (younger children may be considered case-by-case) - You have been diagnosed with DIPG - It has been at least 4 weeks but no more than 12 weeks since you completed radiation therapy - You are neurologically stable for at least 7 days - If you are on steroids, the dose has been stable or decreasing for at least 7 days - You have a life expectancy of at least 6 months **You may NOT be eligible if...** - Your tumor is not visible on imaging - You previously received chemotherapy or targeted therapy in a clinical trial - You have signs of increased brain pressure - You have a ventricular-peritoneal shunt, cerebral aneurysm, or vascular malformation - You are taking blood thinners or medications that increase bleeding risk - You have HIV or active seizures - You have a known allergy to the ultrasound contrast agent or doxorubicin 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(3)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Cook Children's Health Care System

Fort Worth, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05630209


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