[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malignant-brain-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malignant-brain-tumor":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,53,84,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30],"Malignant Brain Tumor","Malignant Glioma","Embryonal Tumor",[32,33,34,35,36,37,38,39],"Low intensity pulsed ultrasound (LIPU)","Therapeutic ultrasound","Blood-brain barrier (BBB)","Malignant brain tumor","Brain cancer","Carboplatin","Children","Adolescents","RECRUITING","2026-04-30",{"date":43,"type":44},"2026-05-06","ACTUAL",{"date":46,"type":44},"2023-02-06",{"date":48,"type":22},"2028-10-01",{"name":50,"class":51},"Assistance Publique - Hôpitaux de Paris","OTHER",3,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100514284","neuropathways-intervention-for-brain-tumor-patients-100514284","NCT05976490","NeuroPathways Intervention for Brain Tumor Patients","NeuroPathways: An Information and Support Intervention for Patients With Malignant Brain Tumors","Inclusion Criteria:\n\n* Age ≥18\n* Massachusetts General Hospital Cancer Center patient\n* Within 6 weeks of diagnosis with a primary malignant brain tumor\n* Able to speak and read in English\n\nExclusion Criteria:\n\n* Inability to provide informed consent as assessed by the study team (e.g., due to neurological impairment such as severe cognitive impairment\u002Fdementia or moderate-to-severe receptive aphasia)\n* Deemed inappropriate to approach by patient's oncologist or study PI","18 Years",{"count":62,"type":22},50,[64],"NA","This goal of this study is to test an information and support intervention for patients with malignant (or \"high-grade\") brain tumors. This study was developed to help patients cope after a brain tumor diagnosis. The main question this study aims to answer is whether this intervention (which includes access to an information guide and one-on-one coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in the coaching sessions, use the guide as desired, and complete a small group of short surveys at three different points in time; some participants will be asked to share feedback via exit interviews.",[28,67,68],"Glioma","Coping Skills",[70,71,72,73],"glioma","supportive care","psychoeducation","information","2025-12-16",{"date":76,"type":44},"2025-12-17",{"date":78,"type":44},"2023-11-07",{"date":80,"type":22},"2027-04-10",{"name":82,"class":51},"Massachusetts General Hospital",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":17,"minAge":60,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":95,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":83},"100523169","clinical-applicantion-of-multi-tracer-petmr-imaging-in-neurological-disordersdisease-100523169","NCT06092125","Clinical Applicantion of Multi-Tracer PET\u002FMR Imaging in Neurological Disorders\u002FDisease","CAMIND","Inclusion Criteria:\n\n1. Patients diagnosed with mild cognitive impairment (MCI) or Alzheimer's disease (AD), rapid eye movement sleep behavior disorder (RBD) or Parkinson's disease (PD), epilepsy, malignant brain tumors based on clinical guidelines.\n2. Patients admitted to our hospital for inpatient treatment.\n\nExclusion Criteria:\n\n1. Patients who have undergone non-invasive\u002Fminimally invasive treatments such as radiotherapy or chemotherapy within the past three weeks. And Patients who have taken Alzheimer's disease-related and Parkinson's disease-related treatment drugs within the past month.\n2. Patients with persistent seizures or status epilepticus that cannot be controlled by medication, resulting in an inability to cooperate with the examination.\n3. patients with poorly controlled blood sugar and ineffective medication intervention.\n4. Patients with absolute contraindications for PET\u002FMR examination.\n5. Karnofsky Performance Score (KPS) \\\u003C60.",true,"60 Years",{"count":94,"type":22},2300,"OBSERVATIONAL","The goal of this clinical trial is to learn about the application of domestic PET\u002FMR in major brain diseases. The main questions it aims to answer are:\n\n* Overcome the bottleneck of early accurate diagnosis and treatment in major brain diseases clinical practice.\n* Promote the clinical application of domestic PET\u002FMR, enhance international competitiveness. Participants will have a PET\u002FMR scan of the brain.",[98,99,100,28],"Alzheimer Disease","Parkinson Disease","Epilepsy","2025-07-14",{"date":103,"type":44},"2025-07-16",{"date":105,"type":44},"2022-10-01",{"date":107,"type":22},"2028-10-31",{"name":109,"class":51},"Xuanwu Hospital, Beijing",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":83},"100523748","ascent-intervention-for-brain-tumor-patients-100523748","NCT06099743","ASCENT Intervention for Brain Tumor Patients","An ACT-Based Supportive Intervention for Patients With Central Nervous System Tumors","Inclusion Criteria:\n\n* Age ≥ 18\n* Massachusetts General Hospital Cancer Center Patient\n* Within 6 months of diagnosis of malignant primary Central Nervous System (CNS) tumor\n* English speaking\n\nExclusion Criteria:\n\n* Inability to provide informed consent as assessed by the study team (e.g., due to severe cognitive impairment\u002Fdementia)\n* Moderate to severe receptive aphasia (Quick Aphasia Battery sentence comprehension subscale \\\u003C 8)\n* Current or imminent hospice enrollment",{"count":118,"type":22},100,[64],"The goal of this study is to refine and test a psychosocial intervention called ASCENT (ACT-based Supportive intervention for patients with CENTral nervous system tumors). This intervention was developed to help patients after being diagnosed with a brain tumor. The main question this study aims to answer is whether this intervention is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in 6 coaching sessions and complete short surveys at four different time points. Some participants will be asked to share feedback via interviews.",[28,67,68,122],"Distress, Emotional",[70,71,124,125,126],"brain tumor","psychological distress","support","2025-07-10",{"date":101,"type":44},{"date":130,"type":44},"2025-05-15",{"date":132,"type":22},"2029-07-31",{"name":82,"class":51}]