RecruitingPhase 1NCT05293197

Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients

Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

24 participants

Start Date

Feb 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Purpose : the aim of this study is to assess the feasibility and safety of ultrasound-induced opening of the blood-brain barrier (BBB) with the SonoCloud-9 implantable ultrasound device in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor treated with carboplatin. Study hypothesis : the blood-brain barrier can be transiently and safely opened with pulsed low intensity ultrasound immediately prior to intravenously delivered chemotherapy. The opening of the BBB with the SonoCloud-9 system will increase the tumor exposure to carboplatin and increase progression-free and overall survival in pediatric patients treated for a recurrent malignant supra-tentorial brain tumor.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a device called SonoCloud — which uses ultrasound to temporarily open the blood-brain barrier (a protective layer around the brain) — can help chemotherapy drugs reach brain tumors more effectively in children and teenagers. **You may be eligible if...** - Your child is between 5 and 17 years old - Your child has a malignant brain tumor above the brainstem (e.g., malignant glioma, ATRT, ependymoma) - The tumor has come back or grown after at least one prior treatment - Your child is scheduled to receive carboplatin chemotherapy - Your child can undergo MRI scans without sedation - Your child's performance level is above 50% on the standard medical scale **You may NOT be eligible if...** - Your child is under 5 or 18 or older - Your child cannot tolerate MRI without sedation - There is a risk of brain herniation (life-threatening brain swelling) - Your child is not receiving carboplatin 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

DEVICESonoCloud® (9 transducers)

SonoCloud®, sonication: dose escalation 6 cycles of sonication


Locations(3)

Institut Curie

Paris, France

Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades

Paris, France

Institut Gustave Roussy

Villejuif, France

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NCT05293197


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