Actively Recruiting

Phase 1
Age: 5Years - 17Years
All Genders
NCT05293197

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-05-06

24

Participants Needed

3

Research Sites

294 weeks

Total Duration

On this page

Sponsors

A

Assistance Publique - Hôpitaux de Paris

Lead Sponsor

C

CarThera

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 5 to less than 18 years old
  • Patient able to receive sonications and perform MRI studies without sedation
  • Diagnosis of supra-tentorial primary malignant brain tumor such as malignant glioma or embryonal tumor (including ATRT, ependymoma)
  • Recurrence or progression of brain tumor after at least one standard treatment; multifocal tumors and metastatic disease allowed
  • Treatment with carboplatin validated by a multidisciplinary meeting
  • Karnofsky performance scale index (≥16 years old) or Lansky performance status (<16 years old) greater than 50%, including those with motor deficits from tumor infiltration
  • No threat of brain herniation or uncontrolled intracranial hypertension
  • Corticosteroids treatment ≤1mg/kg/day
  • Neutrophils count >1.5 x 10^9/L
  • Platelets count >100 x 10^9/L
  • Total bilirubin less than 1.5 times upper limit of normal; AST and ALT less than 2.5 times upper limit of normal
  • Serum creatinine less than 1.5 times upper limit of normal for age or creatinine clearance >70 mL/min/1.73m2
  • Coagulation parameters normal for age (fibrinogen, prothrombin time, activated clotting time)
  • No grade 2 or higher toxicity per NCI-CTCAE v5.0
  • No healed scalp wounds
  • Covered by health insurance
  • For patients aged 15-17 years: negative pregnancy test and effective birth control method
  • Written consent signed by patient if possible and by parents or legal representatives
Not Eligible

You will not qualify if you...

  • Weight less than 15 kg
  • Significant intra-tumoral bleeding or ipsilateral subdural effusion
  • Concurrent antineoplastic treatments other than carboplatin or recent cessation within specified timeframes (e.g., nitrosoureas within 6 weeks, temozolomide within 1 month)
  • Radiotherapy within the last 6 weeks
  • Any other cancer treated within the last 5 years
  • Uncontrolled disease or active infection
  • Any comorbidity or anatomical issue compromising safe device implantation or treatment quality
  • Implanted defibrillator, pacemaker, neurostimulator, cochlear implant, or intracerebral ferromagnetic vascular clip
  • Contraindications to general anesthesia or MRI, or allergy to gadolinium or MRI contrast agents
  • Contraindications to ultrasound contrast agent, including allergies or serious heart and lung conditions
  • Carboplatin hypersensitivity
  • Treatment with phenytoin or fosphenytoin
  • Recent vaccination with attenuated live vaccine
  • Hearing loss grade 3 or higher per CTCAE
  • History of thermoregulation disorder
  • Inability to ensure rigorous medical follow-up
  • Pregnant or lactating women
  • Concurrent treatment with anticoagulants or platelet aggregation inhibitors
  • Concurrent treatment potentially toxic to the central nervous system within 5 half-lives prior to ultrasound session
  • Any treatment judged by the investigator to induce brain toxicity after BBB disruption
  • Use of benzodiazepines, antihistamines, proconvulsants, conventional antipsychotics, barbiturates, MAO inhibitors, anticholinergics, or anticoagulants within 5 half-lives prior to ultrasound session

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Institut Curie

Paris, France, 75005

Actively Recruiting

2

Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades

Paris, France, 75015

Actively Recruiting

3

Institut Gustave Roussy

Villejuif, France, 94800

Actively Recruiting

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Research Team

K

Kevin BECCARIA, MD, PhD

CONTACT

N

Nelly BRIAND, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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