[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461787":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":81,"collaborators":83,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":20,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SonoCloud®","EXPERIMENTAL","SonoCloud® : dose escalation 6 cycles of sonication",[13],"Device: SonoCloud® (9 transducers)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","SonoCloud® (9 transducers)","SonoCloud®, sonication: dose escalation 6 cycles of sonication",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Kevin BECCARIA, MD, PhD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+33 1 71 39 65 92","kevin.beccaria@aphp.fr",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Nelly BRIAND, MD, PhD","+33 1 44 38 18 62","nelly.briand@aphp.fr",[35,55,65],{"facility":36,"status":37,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Institut Curie","RECRUITING","Paris","75005","France","FR",{"type":43,"coordinates":44},"Point",[45,46],2.3488,48.85341,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":20,"email":52},"Franck BOURDEAUT, MD, PhD","+33 1 4432 44 71","franck.bourdeaut@curie.fr",{"name":54,"role":24,"phone":20,"phoneExt":20,"email":20},"Franck BOURDEAUT",{"facility":56,"status":37,"city":38,"state":20,"zip":57,"country":40,"countryCode":41,"cosmosGeoPoint":58,"geoPoint":60,"contacts":61},"Service de neurochirugie Pédiatrique - Hôpital Necker- Enfants Malades","75015",{"type":43,"coordinates":59},[45,46],{"lat":46,"lon":45},[62,63],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"name":64,"role":24,"phone":20,"phoneExt":20,"email":20},"Kevin BECCARIA",{"facility":66,"status":37,"city":67,"state":20,"zip":68,"country":40,"countryCode":41,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Institut Gustave Roussy","Villejuif","94800",{"type":43,"coordinates":70},[71,72],2.35992,48.7939,{"lat":72,"lon":71},[75,79],{"name":76,"role":27,"phone":77,"phoneExt":20,"email":78},"Jacques GRILL, MD, PhD","+33 142116209","jacques.grill@gustaveroussy.fr",{"name":80,"role":24,"phone":20,"phoneExt":20,"email":20},"Jacques GRILL",{"type":82,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[84,87,89,90],{"name":85,"class":86},"CarThera","INDUSTRY",{"name":88,"class":6},"Gustave Roussy, Cancer Campus, Grand Paris",{"name":36,"class":6},{"name":91,"class":6},"URC-CIC Paris Descartes Necker Cochin","100461787","phase-1-safety-study-of-the-repeated-opening-of-the-blood-brain-barrier-with-the-sonocloud-device-to-treat-malignant-brain-tumors-in-pediatric-patients-100461787",false,"NCT05293197","Safety Study of the Repeated Opening of the Blood-brain Barrier With the SonoCloud® Device to Treat Malignant Brain Tumors in Pediatric Patients","Phase I Trial Assessing the Safety of the Repeated Ultrasound-induced Opening of the Blood-brain Barrier in Pediatric Patients With Refractory Supra-tentorial Malignant Brain Tumors Before Chemotherapy Administration","SONOKID","Inclusion Criteria:\n\n* patient aged ≥ 5 years old and \\\u003C 18 years old\n* patient able to receive sonications and perform MRI studies without sedation\n* diagnosis of supra-tentorial primary malignant brain tumor (e.g. malignant glioma, embryonal tumor including ATRT, ependymoma)\n* recurrence or progression of brain tumor after at least a first line of standard treatment (multifocal tumors and metastatic disease allowed)\n* indication of treatment with carboplatin, validated in multidisciplinary meeting\n* Karnofsky performance scale index (patients ≥ 16 years old) or Lansky performance status (patients \\\u003C 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)\n* no threat of brain herniation or uncontrolled intracranial hypertension\n* corticosteroids treatment ≤ 1mg\u002Fkg\u002Fday\n* neutrophils \\> 1.5 x 109\u002FL\n* platelets \\> 100 x 109\u002FL\n* total bilirubin \\\u003C 1.5x upper limit of normal, AST et ALT \\\u003C 2.5x upper limit of normal\n* serum creatinin \\\u003C 1.5x upper limit of normal for the age or creatinine clairance \\>70mL\u002Fmin\u002F1.73m2 (EDTA method or 24h urine)\n* coagulation parameters in the normal limits for age (fibrinogen, prothrombin time and activated clotting time)\n* no grade 2 or more toxicity depending on the NCI-CTCAE v5.0 criteria\n* no healed wound on the scalp\n* covered by health insurance\n* for patients of chilbearing age (15-17 years old) : a negative pregnancy test and an efficient method of birth control\n* written consent signed by the patient (if possible) and his parents or legal representatives.\n\nExclusion Criteria:\n\n* weight \\\u003C15kg\n* significant intra-tumoral bleeding (hematoma) or ipsilateral subdural effusion\n* antineoplastic treatment other than carboplatin taken at the same time or stopped since less than:\n\n  * 6 weeks for nitrosoureas\n  * 1 month for temozolomide\n  * 1 month for bevacizumab\n  * 5 half-lives for tyrosin kinase inhibitors\n  * 3 weeks for any other chemotherapy\n\nfor the first sonication session\n\n* radiotherapy during the last 6 weeks\n* any other cancer treated during the last 5 years\n* any other uncontrolled disease or active infection\n* any other co-morbidity that could compromise participation to the study (in the judgement of the clinical investigator)\n* any anatomical particularity (skull thickness, thin skin) that could compromise a safe implantation of the device and\u002For compromise the quality of the treatment (in the judgement of the clinical investigator)\n* implanted defibrillator\u002Fpacemaker, neurostimulator, cochlear implant, intracerebral ferromagnetic vascular clip\n* any contraindication to general anesthesia\n* any contraindication to MRI or known allergy to gadolinium or other MRI contrast agent\u002F\n* any contraindication to ultrasound contrast agent:\n\n  * allergy to the active substance or any excipient\n  * acute coronary syndrome or uncontrolled ischemic heart disease\n  * chronic heart failure or history of acute heart failure or heart failure grade III or IV\n  * treatment with dobutamine\n  * severe pulmonary arterial hypertension\n  * uncontrolled systemic hypertension\n  * respiratory distress syndrome\n* carboplartin hypersensitivity\n* treatment with phenytoin or fosphenytoin\n* earlier vaccination with attenuated alive vaccine\n* diminished auditory acuity ≥ grade 3 on CTCAE classification\n* history of thermoregulation disorder\n* impossibility of a rigorous medical follow-up due to geographic, social or mental reasons\n* pregnant and lactating women\n* contemporaneous treatment by anticoagulant or platelet aggregation inhibiting drugs\n* 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) :\n\n  * benzodiazepine (or any sedative or hypnotique drug)\n  * antihistamine\n  * proconvulsant drugs\n  * butyrophenone, phenothiazine, or any \"conventional\" antipsychotic drug\n  * barbiturate\n  * MAO inhibitor\n  * anticholinergic\n  * anticoagulant\n* any contemporaneous treatment that, in the judgement of the clinical investigator, could induce brain toxicity after BBB disruption","ALL","5 Years","17 Years",{"count":104,"type":105},24,"ESTIMATED","INTERVENTIONAL",[108],"PHASE1","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.\n\nStudy 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.",[111,112,113],"Malignant Brain Tumor","Malignant Glioma","Embryonal Tumor",[115,116,117,118,119,120,121,122],"Low intensity pulsed ultrasound (LIPU)","Therapeutic ultrasound","Blood-brain barrier (BBB)","Malignant brain tumor","Brain cancer","Carboplatin","Children","Adolescents","2026-04-30",{"date":125,"type":126},"2026-05-06","ACTUAL",{"date":128,"type":126},"2023-02-06",{"date":130,"type":105},"2028-10-01",{"name":5,"class":6},3]