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Title: Study of ultrasound-assisted carboplatin therapy with SonoVue for children with recurrent malignant brain tumors using blood-brain barrier disruption

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on children with recurrent primary supratentorial malignant brain tumors. The study examines a new treatment approach that combines two key elements: a device called SonoCloud-9 that uses ultrasound to open the blood-brain barrier, and a chemotherapy medication called carboplatin given through an intravenous infusion. SonoVue, a contrast agent, is also used during the procedure to help visualize the treatment area.

The purpose of this study is to determine the safest and most effective ultrasound power level that can be used with the SonoCloud-9 device to temporarily open the blood-brain barrier. This opening allows the chemotherapy medication to better reach the tumor. The blood-brain barrier is a natural protective layer that normally prevents many substances, including medications, from entering the brain tissue.

During the study, participants will have the SonoCloud-9 device surgically implanted. They will receive regular treatments where ultrasound is used to open the blood-brain barrier, followed by chemotherapy with carboplatin. The treatment will be repeated in cycles, and doctors will closely monitor how well patients tolerate the procedure and watch for any side effects that may occur.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial preparation
A small device called SonoCloud-9 will be implanted to help deliver medication to your brain
You will need to have stable medication levels, including corticosteroids (≤ 1mg/kg/day) for at least 7 days before starting
Step 2
Pre-treatment checks
Your blood tests will be reviewed to ensure safe treatment levels:
- Blood cell counts (neutrophils > 1.5 x 109/L, platelets > 100 x 109/L)
- Liver function tests
- Kidney function tests
- Blood clotting tests
Step 3
Treatment cycle
The treatment consists of two main parts:
1. Ultrasound treatment using the implanted SonoCloud-9 device to help medication reach the brain tumor
2. Administration of carboplatin medication through an intravenous (IV) line
You will also receive an injection of SonoVue, a contrast agent that helps monitor the treatment
Step 4
Monitoring
Regular MRI scans will be performed to check your response to treatment
Your health will be monitored for any side effects or complications
Blood samples will be collected to test for various tumor markers
Step 5
Follow-up period
Your progress will be monitored for at least 6 months
Regular check-ups will assess how well the treatment is working
The study will continue until October 2027

Who can join the trial?

18 criteria

Age between 5 and 18 years old
Blood platelet count above 100,000 per microliter
Normal liver function tests (bilirubin, AST, and ALT within specified limits)
Normal kidney function (based on creatinine levels or clearance tests)
Normal blood clotting parameters for age
No significant side effects from previous treatments
No unhealed wounds on the scalp
Must have active health insurance coverage
For patients aged 15-17: negative pregnancy test and using effective birth control
Written consent from both patient (if possible) and parents/legal guardians
Able to undergo ultrasound treatments and MRI scans without sedation
Diagnosed with brain tumor above the tentorium (upper part of the brain)
Brain tumor that has returned or grown after at least one standard treatment
Approved for treatment with carboplatin (a chemotherapy drug)
Acceptable physical performance status (ability to carry out daily activities)
No risk of brain herniation or high pressure in the brain
Stable dose of steroid medication for at least 7 days
Normal white blood cell count (neutrophils above 1,500 per microliter)

Who cannot join the trial?

14 criteria

Age below 4 years or above 17 years
Active bleeding disorders or conditions that increase risk of bleeding
Presence of metal implants or devices in the skull that could interfere with ultrasound treatment
Pregnancy or breastfeeding in female patients of childbearing age
Previous radiation therapy to the brain within the last 4 weeks
Severe allergic reactions to carboplatin (the chemotherapy drug used in this study)
Inability to undergo MRI scans (due to metal implants or severe claustrophobia)
Significant heart, kidney, or liver problems that could affect treatment safety
Current participation in other clinical trials
Inability of patient or guardian to provide informed consent
Presence of brain tumors located in areas that cannot be safely reached by the ultrasound device
Active infections or uncontrolled medical conditions
History of seizures not well controlled with medication
Abnormal blood test results that indicate poor organ function

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hopital Beaujon
Verified
Clichy, France
Institut Curie
Verified
Paris, France
Institut Gustave Roussy
Verified
Villejuif, France

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Investigated drugs

Carboplatin
This is a chemotherapy medication given through an intravenous (IV) line. It's used to treat brain tumors. The medication can work better when combined with a special ultrasound treatment that helps it reach the brain more effectively.
SonoCloud®-9
This is not a medication but an implantable medical device that uses ultrasound waves to temporarily open the blood-brain barrier. This helps the chemotherapy medication reach the brain tumor more effectively. The device is surgically implanted and activated before chemotherapy treatment.

What is already known about the treatment

Carboplatin – A platinum-based chemotherapy drug administered intravenously that is used in the treatment of various cancers, including malignant brain tumors. This medication works by binding to DNA in cancer cells, interfering with their ability to divide and grow, ultimately leading to cell death. As a second-generation platinum compound, carboplatin belongs to the alkylating agents class of chemotherapy drugs and is often preferred over similar drugs due to its more manageable side effect profile. In this trial, it is being studied in combination with ultrasound-assisted blood-brain barrier disruption to improve its delivery to brain tumor tissue in pediatric patients. Note: I focused on describing Carboplatin as it's the only medication explicitly mentioned in the trial data. The description includes its administration method, mechanism of action, classification, and current use in medicine, all explained in accessible language.

Investigated diseases

Primary Supratentorial Brain Tumor - A condition where abnormal cells grow and form masses in the upper part of the brain, above the tentorium cerebelli. This type of tumor develops in the cerebrum, which controls thinking, speech, and movement. The tumor can grow and press against other parts of the brain, causing various neurological symptoms. It affects brain tissue directly and can interfere with normal brain functions. When described as recurrent, it means the tumor has returned after initial treatment.