In short
This article provides information about ongoing clinical trials for patients with malignant brain tumors. Currently, there is 1 active trial examining innovative treatment approaches that combine ultrasound technology with chemotherapy to improve medication delivery to brain tumors in children.
Clinical trial locations
Study of ultrasound-assisted carboplatin therapy with SonoVue for children with recurrent malignant brain tumors using blood-brain barrier disruption
This clinical trial is being conducted in France and focuses on children and adolescents with recurrent malignant tumors in the upper part of the brain. The study examines an innovative treatment approach that combines ultrasound technology with chemotherapy to improve how medication reaches the tumor.
Main focus of the trial: The primary goal of this study is to determine the safest and most effective ultrasound power level that can be used to temporarily open the blood-brain barrier. The blood-brain barrier is a natural protective layer that normally prevents many substances, including medications, from entering brain tissue. By carefully opening this barrier using ultrasound, doctors hope to help chemotherapy medication reach the tumor more effectively.
Investigational treatment: The trial uses carboplatin, a platinum-based chemotherapy medication given through an intravenous line. Carboplatin works by interfering with cancer cells' ability to divide and grow. The medication is combined with a surgically implanted device called SonoCloud-9, which uses ultrasound waves to temporarily open the blood-brain barrier. Additionally, SonoVue, a contrast agent, is used during the procedure to help doctors visualize the treatment area.
Who can participate: This trial is designed for children and adolescents between 5 and 18 years of age who have been diagnosed with a brain tumor in the upper part of the brain that has returned or continued to grow after at least one standard treatment. Participants must be approved for treatment with carboplatin and should be able to undergo ultrasound treatments and MRI scans without sedation.
Additional requirements include:
- Normal blood counts, including white blood cells above 1,500 per microliter and platelets above 100,000 per microliter
- Normal liver and kidney function based on laboratory tests
- Normal blood clotting parameters for age
- Stable dose of steroid medication for at least 7 days before starting treatment
- Good physical performance status and ability to carry out daily activities
- No risk of brain herniation or dangerously high pressure in the brain
- For adolescents aged 15-17: negative pregnancy test and use of effective birth control
- Written consent from both the patient (when possible) and parents or legal guardians
- Active health insurance coverage
Who cannot participate: The trial excludes patients with certain medical conditions that could make the treatment unsafe or interfere with its effectiveness. Children younger than 5 years or older than 18 years cannot participate. Other exclusion factors include:
- Active bleeding disorders or conditions that increase bleeding risk
- Metal implants or devices in the skull that could interfere with ultrasound treatment
- Pregnancy or breastfeeding in female patients
- Recent radiation therapy to the brain within the last 4 weeks
- Severe allergic reactions to carboplatin
- Inability to undergo MRI scans due to metal implants or severe claustrophobia
- Significant heart, kidney, or liver problems
- Active infections or uncontrolled medical conditions
- Brain tumors located in areas that cannot be safely reached by the ultrasound device
- History of seizures not well controlled with medication
- Abnormal blood test results indicating poor organ function
Treatment process: Participants will undergo several steps during the trial. First, the SonoCloud-9 device will be surgically implanted. Before each treatment cycle, doctors will review blood tests to ensure safe treatment levels. During treatment, the ultrasound device will be activated to open the blood-brain barrier, followed by administration of carboplatin through an intravenous line. Regular MRI scans will be performed to monitor response to treatment, and blood samples will be collected to test for various tumor markers. Patients will be monitored for at least 6 months, with the study continuing until October 2027.
Summary
Currently, there is one active clinical trial examining innovative treatment approaches for children and adolescents with recurrent malignant brain tumors. This trial, conducted in France, focuses on combining ultrasound technology with chemotherapy to overcome one of the major challenges in treating brain tumors: the blood-brain barrier that prevents many medications from reaching brain tissue effectively.
The trial uses carboplatin, a well-established chemotherapy medication, in combination with an implantable ultrasound device to improve drug delivery to the tumor. This approach represents an important area of research in pediatric neuro-oncology, as recurrent brain tumors in children remain particularly difficult to treat. The study carefully monitors both the safety and effectiveness of this combined approach, with close attention to determining the optimal ultrasound power level that can safely open the blood-brain barrier without causing harm.
Patients interested in participating should discuss eligibility requirements with their medical team, as the trial has specific criteria regarding age, tumor location, previous treatments, and overall health status.
