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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

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What is this study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Hopital Beaujon Clichy France
Ieomvklb Cxqni Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
06.02.2023

Trial locations

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.

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.

Trial ID:
2024-516169-35-00
Protocol code:
D20181321
NCT ID:
NCT05293197
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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