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Phase I trial evaluating the tolerance of repeated opening of the bloodbrain barrier by ultrasound before chemotherapy in the treatment of recurrent primary supratentorial malignant brain tumors in children
EU CTIS ID: 2024-516169-35-00
What this study is testing
To determine the maximum tolerated ultrasound power for inducing blood-brain barrier (BBB) opening using the implantable SonoCloud®-9 (SC9) device in the treatment of recurrent or progressive malignant supratentorial brain tumors in pediatric patients receiving intravenous (IV) carboplatin.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- patient aged ≥ 5 years old and < 18 years old
- 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
You likely can't join if
- weight <15kg
- 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
See the full eligibility criteria
Who can join
- patient aged ≥ 5 years old and < 18 years old
- 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.
- 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 stable for the last 7 days
- neutrophils > 1.5 x 109/L
What rules you out
- weight <15kg
- 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
- significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion
- 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
- 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
- radiotherapy during the last 6 weeks
- patient with another malignant tumour (other than the primary brain tumour) requiring concomitant treatment.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.