RecruitingPHASE1INTERVENTIONAL

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

This study is testing a new device called SonoCloud® in children aged 5 to 17 who have a type of brain tumour that has returned. The brain has a natural protection called the 'blood-brain barrier' which stops many medicines, including chemotherapy, from getting to the tumour. The SonoCloud® device uses sound waves to gently and temporarily open this barrier. The idea is that by opening this barrier just before giving chemotherapy (carboplatin), more of the medicine can reach the tumour. This initial study will check if this method is safe and if it works as expected. If successful, it could offer a new way to make brain tumour treatments more effective for children.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

06 Feb 2023

Estimated completion

01 Oct 2028

Malignant Brain Tumor Malignant Glioma Embryonal Tumor

What is this study about?

Brain tumours are unfortunately a significant health concern for children. One big challenge in treating these tumours is something called the 'blood-brain barrier'. Think of it as a very clever security system for your brain. It's really good at protecting the brain from harmful substances, but it also stops many helpful medicines, like chemotherapy drugs, from getting where they need to go – to the tumour.

Researchers have found a way to temporarily and safely get past this barrier using sound waves. This study is testing a special implantable device called SonoCloud®. This small device is placed under the skin and directly on the skull. It uses gentle, low-intensity sound waves to open up the blood-brain barrier for a short time, just before a child receives chemotherapy. The device is not visible and is safe for MRI scans.

The main goal of this study is to see how safe and practical it is to use the SonoCloud® device to open the blood-brain barrier in children aged 5 to 17 who have a type of brain tumour that has come back. The hope is that by allowing more of the chemotherapy medicine (carboplatin in this case) to reach the tumour, the treatment will be more effective. This type of study, called a Phase 1 study, is focused on ensuring the new method is safe for patients, before moving on to test how well it works.

Key takeaways

New study for children aged 5-17 with recurrent brain tumours.
Uses a special SonoCloud® device to temporarily open the blood-brain barrier.
Aims to help chemotherapy (carboplatin) reach the tumour more effectively.
First, checks safety and whether the method is practical.
Could offer a new approach to brain tumour treatment for children.

Who may be eligible?

This study is looking for children and young people between the ages of 5 and 17 who have a specific type of brain tumour that has reappeared or worsened after previous treatment. They must be considered suitable for treatment with a chemotherapy drug called carboplatin by their medical team.

To join, a child needs to be well enough to have the treatment and MRI scans without needing to be put to sleep. Their general health, including blood tests and how well their kidneys and liver are working, will be checked to make sure they can safely take part. There are also health conditions that would prevent participation, such as certain bleeding issues or if other cancer treatments have been given very recently.

Parents or legal guardians will need to give their written permission for the child to join the study, and if the child is old enough, their agreement will also be sought.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child between 5 and 17 years old?
Does your child have a malignant brain tumour that has come back?
Is your child's medical team considering carboplatin chemotherapy?
Can your child undergo scans (like MRI) without needing to be sedated?
Are your child's general health, blood counts, and organ functions within healthy ranges?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will have a small device, the SonoCloud®, surgically placed. This device will be used to open the blood-brain barrier using sound waves just before they receive their carboplatin chemotherapy. Your child will have regular treatments over cycles lasting six months. If the treatment is well-tolerated and helpful, they may be able to continue for another six months.

Throughout the study, your child will have regular check-ups, including blood tests and MRI scans, to monitor their health, the tumour, and how the SonoCloud® device is working. This will help the doctors understand if the treatment is safe and effective. The team will explain the full schedule of hospital visits and tests involved.

Potential risks and benefits

Potential benefits of taking part could include the possibility that the chemotherapy medicine reaches the brain tumour more effectively, which might lead to a better treatment outcome. However, as this is an early-stage study, we cannot guarantee individual benefits. Like any medical procedure, there are potential risks, including those related to the surgery to implant the device, the use of sound waves, and side effects from the chemotherapy itself. The research team will carefully explain all known risks. Remember, participation is always voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without affecting their standard medical care.

Locations (3)

Institut Curie
Verified postcode
Paris, France· Recruiting
Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades
Verified postcode
Paris, France· Recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is the SonoCloud® device?

It's a small, implantable device that uses gentle sound waves to temporarily open the brain's natural protective barrier, helping chemotherapy reach the tumour better.

Will my child feel anything when the barrier is opened?

The process uses low-intensity sound waves and is designed to be gentle. The medical team will monitor your child closely during this time.

How long will my child be in the study?

The treatment will run in cycles, initially for six months. If it's well-tolerated, your child might continue for another six months.

Is the SonoCloud® device visible?

No, it's designed to be placed under the skin and is not visible from the outside. It's also safe for MRI scans.

What is carboplatin?

Carboplatin is a type of chemotherapy medicine commonly used to treat various cancers, including some brain tumours.

How to find out more

Kevin BECCARIA, MD, PhD

kevin.beccaria@aphp.fr +33 1 71 39 65 92 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.