Status:
RECRUITING
Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
CarThera
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Malignant Brain Tumor
Malignant Glioma
Eligibility:
All Genders
5-17 years
Phase:
PHASE1
Brief Summary
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 p...
Detailed Description
Malignant brain tumors are the first cause of death by cancer in children and adolescents. The dismal prognosis of malignant brain tumors is partially due to the existence of the blood brain barrier (...
Eligibility Criteria
Inclusion
- patient aged ≥ 5 years old and \< 18 years old
- patient able to receive sonications and perform MRI studies without sedation
- diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma)
- recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed)
- indication of treatment with carboplatin, validated in multidisciplinary meeting
- Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients \< 16 years old) \> 50% (a patient with a performance status score altered by a motor deficit due to tumor infiltration will be allowed to be included)
- no threat of brain herniation or uncontrolled intracranial hypertension
- corticosteroids treatment ≤ 1mg/kg/day
- neutrophils \> 1.5 x 109/L
- platelets \> 100 x 109/L
- total bilirubin \< 1.5x upper limit of normal, AST et ALT \< 2.5x upper limit of normal
- serum creatinin \< 1.5x upper limit of normal for the age or creatinine clairance \>70mL/min/1.73m2 (EDTA method or 24h urine)
- coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)
- no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria
- no healed wound on the scalp
- covered by health insurance
- for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control
- written consent signed by the patient (if possible) and his parents or legal representatives.
Exclusion
- weight \<15kg
- significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion
- antineoplastic treatment other than carboplatin taken at the same time or stopped since less than:
- 6 weeks for nitrosoureas
- 1 month for temozolomide
- 1 month for bevacizumab
- 5 half-lives for tyrosin kinase inhibitors
- 3 weeks for any other chemotherapy
- for the first sonication session
- radiotherapy during the last 6 weeks
- any other cancer treated during the last 5 years
- any other uncontrolled disease or active infection
- any other co-morbidity that could compromise participation to the study (in the judgement of the clinical investigator)
- any anatomical particularity (skull thickness, thin skin) that could compromise a safe implantation of the device and/or compromise the quality of the treatment (in the judgement of the clinical investigator)
- implanted defibrillator/pacemaker, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip
- any contraindication to general anesthesia
- any contraindication to MRI or known allergy to gadolinium or other MRI contrast agent/
- any contraindication to ultrasound contrast agent:
- allergy to the active substance or any excipient
- acute coronary syndrome or uncontrolled ischemic heart disease
- chronic heart failure or history of acute heart failure or heart failure grade III or IV
- treatment with dobutamine
- severe pulmonary arterial hypertension
- uncontrolled systemic hypertension
- respiratory distress syndrome
- carboplartin hypersensitivity
- treatment with phenytoin or fosphenytoin
- earlier vaccination with attenuated alive vaccine
- diminished auditory acuity ≥ grade 3 on CTCAE classification
- history of thermoregulation disorder
- impossibility of a rigorous medical follow-up due to geographic, social or mental reasons
- pregnant and lactating women
- contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs
- contemporaneous treatment possibly toxic for the central nervous system. The following treatments are excluded if taken less than 5 half-lives before the ultrasound session (unknown toxicity in case of BBB disruption) :
- benzodiazepine (or any sedative or hypnotique drug)
- antihistamine
- proconvulsant drugs
- butyrophenone, phenothiazine, or any "conventional" antipsychotic drug
- barbiturate
- MAO inhibitor
- anticholinergic
- anticoagulant
- any contemporaneous treatment that, in the judgement of the clinical investigator, could induce brain toxicity after BBB disruption
Key Trial Info
Start Date :
February 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05293197
Start Date
February 6 2023
End Date
October 1 2027
Last Update
November 20 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut Curie
Paris, France, 75005
2
Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades
Paris, France, 75015
3
Institut Gustave Roussy
Villejuif, France, 94800