[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-tumor-pediatric\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-tumor-pediatric":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,47,86,112,139,180,205,231,267,293],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":16,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635883","measuring-brain-changes-following-cognitive-intervention-in-pediatric-patients-with-brain-tumors-100635883",false,"NCT07558473","Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors","Inclusion Criteria:\n\n1. Patients with a primary tumor located in the brain\n2. Diagnosed between 0 and 25 years of age\n3. Within five years of cancer diagnosis\n4. Receiving care at Johns Hopkins Hospital\n\nExclusion Criteria:\n\n1\\. Patients with a primary tumor outside of the brain","ALL","25 Years",{"count":18,"type":19},300,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this study is to learn if an online computerized training program improves processing speed in children with pediatric brain tumors. The main questions it aims to answer are:\n\n1. Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?\n2. Is the cognitive intervention acceptable to patients and caregivers?\n3. Does the cognitive intervention improve neuropsychological functioning?\n\nThere is no comparison group for this study.\n\nParticipants will:\n\n1. Complete 15 minutes of online computerized cognitive training 5 times a week for 8 weeks.\n2. Have weekly check-ins with the cognitive coach.\n3. Fill out acceptability surveys at the end of the cognitive intervention.\n4. Complete pre- and post- neuropsychological testing.",[25],"Brain Tumor, Pediatric",[27,28,29,30,31,32,33],"Brain Tumor","Pediatric","Pediatric Brain Tumor","Cognitive Intervention","Intervention","Oncology","Cancer","NOT_YET_RECRUITING","2026-06-25",{"date":37,"type":38},"2026-06-26","ACTUAL",{"date":40,"type":19},"2026-07-30",{"date":42,"type":19},"2033-04-01",{"name":44,"class":45},"Hugo W. Moser Research Institute at Kennedy Krieger, Inc.","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":20,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100585686","phase-3-methylphenidate-in-pediatric-brain-tumor-survivors-with-cancer-related-fatigue-100585686","NCT06905587","Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue","Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial","EMBRAIN","Inclusion Criteria:\n\n1. Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).\n2. Treated for a PBT during the previous 10 years, starting from date of diagnosis.\n3. Aged ≥6 years 0 months at the start of the trial.\n4. Off therapy\u002Factive treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.\n5. No known signs of clinical or radiological tumor progression at last follow-up.\n6. Danish is the sole or primary language (enabling provision of validated assessment tools).\n7. Patient and family have provided consent for inclusion in the trial.\n8. Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.\n9. History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.\n\nExclusion Criteria:\n\n1. Any known contraindications to methylphenidate as outlined below:\n\n   A) Hypersensitivity to the active substance or any excipients listed in the summary of product characteristics. B) Glaucoma. C) Pheochromocytoma. D) Hyperthyroidism. E) Mania. F) Psychosis. G) Anorexia nervosa. H) Current or previous severe depression. I) Suicidal behavior. J) Poorly controlled type 1 bipolar affective disorder. K) Antisocial or borderline personality disorder. L) Pre-existing cardiovascular disorders, including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening cardiac arrhythmias and channelopathies. M) Pre-existing cerebrovascular disease, cerebral aneurysm, vascular abnormalities including vasculitis or stroke. N) Treatment with irreversible MAO inhibitors within the last 14 days and reversible MAO inhibitors within the last 24 hours.\n2. History of recent poorly controlled seizures.\n3. Motor tics or Tourette syndrome (including family history of tic disorder).\n4. Known diagnosis of Attention Deficit\u002FHyperactivity Disorder or Autism Spectrum Disorder.\n5. Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \\\u003C50.\n6. Pregnancy. Participants known to be pregnant or breastfeeding at screening\u002Fregistration will not be enrolled in the trial. All sexually active women of childbearing potential (WOCBP) must have a negative pregnancy test prior to the start of treatment. Acceptableeffective contraceptive must be used for the duration of the trial. No further testing is needed during trial, unless the participant suspects to have become pregnant.\n7. Concerns about family ability to safely store or administer MPH, or to report side effects appropriately\u002Fconcerns about familial substance abuse.\n8. Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).\n9. Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention.","6 Years","27 Years",{"count":58,"type":19},50,[60],"PHASE3","Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.\n\nThe researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit\u002Fhyperactivity disorder (ADHD).\n\nIf methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.",[25,63,64],"Cancer-related Fatigue","Methylphenidate",[66,67,68,69,70,71,72,73,74,75],"methylphenidate","cancer-related fatigue","brain tumor","childhood cancer","pediatric cancer","childhood cancer survivor","late effect","long-term effects secondary to cancer therapy in children","long-term effects of cancer-treatment","pediatric brain tumor","RECRUITING","2026-06-23",{"date":37,"type":38},{"date":80,"type":38},"2025-09-02",{"date":82,"type":19},"2029-12",{"name":84,"class":45},"Odense University Hospital",4,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":15,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":20,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":46},"100481813","utility-of-pet-mri-in-surveillance-of-paediatric-brain-tumours-100481813","NCT05553899","Utility of PET-MRI in Surveillance of Paediatric Brain Tumours","Utility of PET-MRI in Post-treatment Surveillance of Paediatric Brain Tumours: a Pilot Study","PET-MRI","Inclusion Criteria:\n\n* Have a presumptive or histologically confirmed diagnosis of a malignant brain tumour requiring treatment\n* Diagnostic uncertainty about tumour recurrence post-treatment based on conventional MR imaging in the opinion of the MDT\n* Have a life expectancy of at least three months\n* Able to comply with an MRI scan without a general anaesthetic\n\nExclusion Criteria:\n\n* Unable to comply with an MRI scan without a general anaesthetic\n* Diabetes or other causes of hyperglycaemia\n* Pregnancy\n* Patient body habitus above scanner dimensions\n* Standard contra-indication to MRI (eg. pacemaker, non-compatible metallic implants, altered renal function)","8 Years","18 Years",{"count":97,"type":19},5,[22],"This is a pilot project to explore the utility of PET-MRI in the post-treatment surveillance of high-grade gliomas or medulloblastomas in children in our institution.",[25],[102],"Brain Tumor, children, PET, MRI","2026-04-29",{"date":105,"type":38},"2026-05-06",{"date":107,"type":38},"2024-02-28",{"date":109,"type":19},"2027-06",{"name":111,"class":45},"Sheffield Children's NHS Foundation Trust",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":20,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100562185","irradiation-in-paediatrics-neurocognition-neuroimaging-and-evaluation-of-memory-and-attention-100562185","NCT06599879","Irradiation in Paediatrics: Neurocognition, Neuroimaging and Evaluation of Memory and Attention","IPANEMA","Inclusion Criteria:\n\n1. Patient who has received localised brain irradiation or craniospinal irradiation for a brain tumour whose treatment includes first-line radiotherapy.\n2. Patient with one of the following tumour types: ependymomas, medulloblastomas, malignant germ cell tumours, craniopharyngioma, pinealoblastoma.\n3. Patient aged between 4 and 12 years at the time of radiotherapy treatment.\n4. End of irradiation within 2 years (+\u002F-3 months) prior to inclusion.\n5. Patient having been treated by photontherapy or proton therapy.\n6. Sufficient visual, auditory (with authorised hearing aid) and oral or written expression capacity to carry out the neuropsychological tests properly.\n7. Proficiency in the French language by the patient and parent(s).\n8. Patient affiliated to a Social Security scheme in France.\n9. Informed consent signed by the patient\u002Flegal parent(s)\u002Fguardian(s) in accordance with French law and Good Clinical Practice.\n\nExclusion Criteria:\n\n1. Patient presenting with severe ataxia.\n2. Patient with a recurrence of the disease.\n3. Not applicable since protocol version 2. Metastatic patient.\n4. Any contraindication to MRI for patients included in Toulouse (i.e. in particular patients with a pacemaker or cardiac defibrillator, implanted equipment activated by an electrical, magnetic or mechanical system, patients with haemostatic clips on intracerebral aneurysms, patients with orthopaedic implants, claustrophobic patients).\n5. Patients undergoing psychostimulant or psychotropic treatment (in particular methylphenidate, antidepressants).\n6. Any psychological, family, geographical or sociological condition that prevents compliance with medical monitoring and\u002For the procedures set out in the study protocol.\n7. Patients deprived of their liberty or under legal protection.\n8. Severe posterior fossa syndrome with akinetic mutism.","14 Years",{"count":121,"type":19},130,[22],"This is a prospective, open-label, multicentric study designed to correlate the dose delivered to the hippocampus with declarative memory deficits 2 years after radiotherapy treatment in a paediatric population who had received brain irradiation between the ages of 4 and 12 for a brain tumour.\n\nIn order to meet this objective, several neuropsychological assessments consisting of parental questionnaires and cognitive tests will be carried out during the course of the study, at the following two stages:\n\n* A 1st assessment at patient inclusion, i.e. 2 years after the end of radiotherapy treatment,\n* And a second assessment 2 years after patient inclusion, i.e. 4 years after the end of radiotherapy treatment.\n\nA retrospective assessment of the patient's neurocognitive level 1 year before the diagnosis of the disease will also be carried out at inclusion, with the parents completing a questionnaire specifically designed for the trial.\n\nIn addition, patients who have received their radiotherapy treatment at the IUCT-O will be offered participation in the ancillary imaging study. If the parents and the patient agree, multimodal MRI scans specific to the study (without injection of contrast) will be performed at inclusion and 2 years after inclusion.\n\nImaging and radiotherapy data will be collected in parallel using the PediaRT software used in current practice (collection of radiotherapy dosimetric data as well as standard MRI examinations pre-operatively, post-operatively, and at the 2-year and 4-year follow-up).\n\n130 patients will be included in this study.",[25],[25,126,127,128],"Radiotherapy","Neurocognitive sequelae","Imaging","2026-04-08",{"date":131,"type":38},"2026-04-13",{"date":133,"type":38},"2025-10-21",{"date":135,"type":19},"2030-10",{"name":137,"class":45},"Institut Claudius Regaud",15,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":15,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":20,"phases":150,"briefSummary":152,"conditions":153,"keywords":166,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":179},"100622970","phase-1-b7-h3cd28zcart-in-cns-neoplasms-100622970","NCT07390539","B7-H3.CD28Z.CART in CNS Neoplasms","A Phase 1\u002F1b Study of Autologous b7-h3 Chimeric Antigen Receptor t Cells (b7-h3.cd28z.Cart) in Children and Young Adults With Recurrent or Progressive Cns Neoplasms Expressing b7-h3 Target","Pre-screening Inclusion Criteria:\n\n* Participants must have histologically and\u002For molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent\u002Fprogressive following standard of care treatment.\n\n  --Eligible CNS embryonal tumor types include:\n  * Medulloblastoma\n  * Atypical Teratoid Rhabdoid Tumor (ATRT)\n  * Embryonal Tumor with Multilayered Rosettes (ETMR) Pineoblastoma\n  * Other CNS embryonal tumor types, at the discretion of the study chair (or designee)\n* Participants must have adequate pre-trial tumor material available to determine B7- H3 expression status. Tumor tissue from the most recent resection or biopsy of recurrent disease is preferred. If unavailable, tumor tissue from prior recurrences or from time of initial diagnosis is acceptable. Biopsies will not be performed for participation in this research trial or for research purposes.\n* Pre-screening IHC Consent: All participants ≥ 18 years of age must be able to give informed consent. For participants \\\u003C18 years of age, their legal authorized representative (LAR) (i.e. parent or guardian) must give informed consent. Pediatric participants will be included in age-appropriate discussion and written assent will be obtained for those ≥10 years of age, where appropriate. If a minor becomes of age during participation of this study, they will be asked to reconsent as an adult.\n\nInclusion Criteria:\n\n* Participants must have histologically and\u002For molecularly confirmed CNS embryonal tumor (see eligible tumor types below), OR ependymoma that is recurrent\u002Fprogressive following standard of care treatment.\n\n  --Eligible CNS embryonal tumor types include:\n  * Medulloblastoma\n  * Atypical Teratoid Rhabdoid Tumor (ATRT)\n  * Embryonal Tumor with Multilayered Rosettes (ETMR)\n  * Pineoblastoma\n  * Other CNS embryonal tumor types, at the discretion of the study chair (or designee)\n* B7-H3 expression: Demonstration of B7-H3 expression with H score greater than 100 by immunohistochemistry (IHC) is required.\n* Age: greater than or equal to two (2) years of age and less than or equal to 21 years of age. The first participant treated at each dose level within each stratum (Standard Risk and High Risk) will be ≥ 6 years of age when feasible.\n* Disease status: Participants must have evaluable disease in the central nervous system to be eligible. Evaluable disease includes either measurable OR non-measurable disease, defined as follows:\n\n  --Measurable disease (contrast-enhancing or non-enhancing tumor)\n  * Clearly defined lesional margins with two perpendicular diameters of at least 10mm, OR\n  * At least two times (in both perpendicular diameters) the MRI slice thickness, plus the interslice gap\n\n    --Non-measurable disease (tumor that is too small to be accurately measured)\n  * Lesion that is measurable in only one perpendicular dimension, OR\n  * Lesion that is less than 10mm in at least one perpendicular dimension, OR\n  * Lesion that is less than two times the MRI slice thickness, plus the interslice gap\n  * Note: Leptomeningeal (LM) disease is considered non-measurable but evaluable.\n* Performance status: Karnofsky performance status ≥60% for participants ≥16 years of age and Lansky performance status ≥60% for participants \\\u003C16 years of age (see APPENDIX A PERFORMANCE STATUS CRITERIA). NOTE: Participants with neurologic deficits must have a stable neurologic exam for seven (7) days prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Life expectancy of greater than 12 weeks\n* Prior therapy: Participants must have received prior standard of care therapy, including maximal safe surgical resection, radiation therapy and\u002For standard chemotherapy, and is recovered from all acute treatment-related toxicities (defined as ≤ Grade 1 or stable) from all prior therapy before entering this study There is no upper limit to the number of prior therapies allowed, but must have received all standard curative options for their tumor type.\n* Participants must meet the following washouts prior to enrollment:\n\n  * Radiation therapy - Participants must have had their last fraction of:\n\n    ---Craniospinal irradiation, whole brain radiation therapy, or radiation therapy to \\>50% of the pelvis or spine \\>28 days prior to enrollment\n\n    ---Focal irradiation (small port) \\>14 days prior to enrollment\n  * At least 14 days since any prior cytotoxic chemotherapy\n  * At least 7 days since any biologic antineoplastics, tyrosine kinase inhibitor, targeted agent\n  * At least 21 days or 5 half-lives (whichever is shorter) since any investigational antineoplastic or disease-directed agent (but at least 28 days from prior investigational antineoplastic vaccine therapy)\n  * At least 21 days since any monoclonal antibody therapy\n  * At least 90 days since any systemic inhibitor\u002Fstimulatory immune checkpoint therapy\n  * At least 28 days from prior autologous stem cell transplantation, with no ongoing toxicities\n  * At least 14 days after peg-filgrastim and 7 days for hematopoietic growth factor support\n* Steroid use: Must not require concurrent systemic steroid therapy, although physiologic corticosteroid replacement therapy for management of pituitary\u002Fadrenal insufficiency and\u002For topical administration (e.g. inhaled or dermatologic) is allowed. Use of topical, ocular, intranasal, or inhaled corticosteroids are permitted per PI\n\ndiscretion.\n\n* Participants must have adequate organ function, as defined below\n\n  --Adequate bone marrow function\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Absolute neutrophil count (ANC) ≥ 1000 cells\u002FuL\n  * Absolute lymphocyte count (ALC) ≥ 150 cells\u002FuL\n  * Platelets ≥100,000\u002FuL (unsupported, defined as no platelet transfusion within 4 days)\n* Adequate renal function defined as creatinine within normal limits for age OR creatinine clearance (as estimated by Cockcroft Gault Equation for participants ≥ 18yo and Bedside Schwartz for participants \\\u003C18yo) ≥70mL\u002Fmin\n\n  * Maximum Serum Creatinine mg\u002FDL ---6 months to 1 year Male 0.5 Female 0.5 ---1 to \\\u003C 2 years Male 0.6 Female 0.6 ---2 to \\\u003C 6 years Male 0.8 Female 0.8\n\n    * 6 to \\\u003C 10 years Male 1 Female 1\n    * 10 to \\\u003C 13 years Male 1.2 Female 1.2\n    * 13 years to \\\u003C 16 years Male 1.5 Female 1.4\n\n      * 16 years Male 1.7 Female 1.4\n* Adequate hepatic function\n\n  * Serum ALT\u002FAST ≤3.0 upper limit of normal (ULN)\n  * Total bilirubin ≤1.5mg\u002FdL, except in subjects with confirmed Gilbert's syndrome\n* Adequate cardiac function\n\n  --Ejection fraction ≥50% or fractional shortening ≥28%, measured by echocardiography\n* Adequate pulmonary function\n\n  * No evidence of dyspnea at rest\n  * Pulse oximetry \\>92% whilst breathing room air\n* Adequate neurologic function\n\n  * Participants with seizure disorders on anticonvulsants may be enrolled if seizures are well controlled (no seizure activity within 7 days prior to enrollment)\n  * Nervous system disorders (CTCAE v6.0) resulting from prior therapy must be ≤ Grade 2, with the exception of decreased tendon reflex (DTR; any Grade eligible). Participants with neurological deficits should be stable for a minimum of 7 days prior to enrollment. (A baseline detailed neurological exam should clearly document the neurological status of the participant prior at enrollment).\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization are not considered to be of childbearing potential)\n* Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for one year after receiving the preparative lymphodepletion regimen, or for as long as B7- H3.CD28Z.CART cells are detectable in peripheral blood or CSF, whichever is later.\n* Participant or parent of participant or legally recognized representative must be able to sign a written informed consent document. Pediatric participants will be included in age-appropriate discussion and written assent will be obtained for those ≥10 years of age, where appropriate.\n\nExclusion Criteria:\n\n* Participants with bulky tumor are ineligible. Bulky tumor is defined as:\n\n  * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR sequence\n  * Tumor with evidence of clinically significant midline shift or uncal herniation\n  * Tumor that, in opinion of the site investigator, shows significant mass effect in either the brain or spine\n* Participants with clinical or radiological evidence of brain herniation.\n* Participants who have received other B7-H3 targeted cellular therapies. Other prior cellular therapies are eligible, including immune checkpoint inhibition and vaccine therapy. These prior therapies should be discussed with the study chair (or designee) prior to participant enrollment.\n* Concurrent illness\n\n  * Participants with any prior immunodeficiency or history of autoimmune disease requiring systemic steroids\u002F immunosuppressive medication\u002F disease-modifying agents within the last two (2) years.\n  * Uncontrolled (Grade 3) bacterial, viral, fungal, or other infection.\n  * Ongoing infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n  * Evidence of severe or uncontrolled systemic disease (e.g. Grade 3 significant cardiac, pulmonary, hepatic, renal or other organ dysfunction) that in the judgement of the principal investigator is likely to interfere with assessment of safety or efficacy of the investigational regimen and its requirements.\n  * Known sensitivity or allergy to any of the agents\u002Freagents used in this study (i.e. DSMO, cyclophosphamide, fludarabine)\n  * History of severe hypersensitivity reaction to compounds of similar chemical or biologic compositions to any agent used in the study or in the manufacturing of cells.\n* Concomitant medications\n\n  * Current systemic corticosteroid therapy\n  * Note, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency will be allowed.\n  * Participants who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n  * Participants who have received the last vaccination of a live vaccine ≤ 30 days prior to the start of treatment are ineligible.\n  * Ongoing use of dietary supplements, alternative therapies or extreme diets, or any medication not approved by the study chair (or designee).\n* Any other condition which in the principal investigator's opinion makes the individual clinically unsuitable to participate in this trial, or which would jeopardize compliance with the protocol, or would make it difficult to interpret adverse events or study data.","2 Years","21 Years",{"count":149,"type":19},70,[151],"PHASE1","The purpose of this research study is to test the safety and effectiveness of a cell therapy at different doses for children and young adults with recurrent or progressive brain tumors. Recurrent\u002Frecurred means a tumor that has gone away and then came back. This cell therapy is called B7- H3.CD28Z.CART, referred to as B7-H3 CAR T cells. B7-H3 is a protein that is over-expressed on many tumor cells, making it a good target for cancer cell therapy.\n\nThe names of the study investigational therapies involved in this study are:\n\n* Fludarabine (a type of chemotherapy)\n* Cyclophosphamide (a type of chemotherapy)\n* B7-H3 CAR T cells (a type of cellular therapy)",[154,27,155,25,156,157,158,159,160,161,162,163,164,165],"Central Nervous System Neoplasms","Brain Tumor, Recurrent","Brain Tumor Adult","Medulloblastoma","Medulloblastoma, Childhood","Medulloblastoma, Adult","Medulloblastoma Recurrent","Ependymoma","Atypical Teratoid\u002FRhabdoid Tumor","Embryonal Tumor With Multilayered Rosettes","Pineoblastoma","Leptomeningeal Disease",[154,27,25,167,168,157,158,159,160,161,162,169,164,165],"Brain Tumor, Adult","Brain Tumor Recurrent","Embryonal Tumor with Multilayered Rosettes","2026-01-28",{"date":172,"type":38},"2026-02-05",{"date":174,"type":19},"2026-07",{"date":176,"type":19},"2032-08-31",{"name":178,"class":45},"Robbie Majzner",2,{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":20,"phases":191,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":46},"100618969","intensity-modulated-proton-therapy-in-pediatric-brain-tumors-import-100618969","NCT07338526","Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT)","Intensity Modulated PrOton Therapy in Pediatric BRain Tumors (IMPORT): A Phase 3 Randomized Controlled Trial","IMPORT","Inclusion Criteria:\n\n* Age at irradiation: 6 to 16 years\n* Karnofsky\u002F Lansky Play Performance Status ≥ 60\n* Diagnosis (histopathological\u002F radiological) of primary brain tumor with an expected survival of \\>5 years (e.g., circumscribed gliomas, low grade gliomas, low-grade glial\u002F glioneuronal tumors, meningioma, pituitary tumors, schwannoma, craniopharyngioma, ependymoma)\n* Planned for focal cranial radiotherapy\n* Informed consent taken\n\nExclusion Criteria:\n\n* Re-irradiation\n* Palliative radiotherapy\n* Multifocal or multicentric disease\n* Planned for whole brain irradiation or craniospinal irradiation\n* Planned for hypo-fractionated or stereotactic radiotherapy","16 Years",{"count":190,"type":19},94,[22],"Children diagnosed with benign or low-grade brain tumors often require radiation therapy to control their disease. While radiation can be effective, traditional techniques using X-rays (photon-based radiotherapy) expose healthy brain tissue to radiation, potentially leading to long-term side effects like memory loss, learning difficulties, hormone imbalances, hearing problems, and a higher risk of secondary cancers. This study, called the IMPORT Trial, aims to compare two types of radiation therapy-Intensity-Modulated Proton Therapy (IMPT) and Intensity-Modulated Radiation Therapy (IMRT)-to determine which is safer and more effective for children. IMPT, a newer technique, uses protons instead of X-rays to deliver radiation, reducing exposure to healthy brain tissue. Researchers believe this could help minimize long-term damage while maintaining effective tumor control.\n\nWhat is the goal of the study?\n\nThe primary goal is to see if IMPT leads to better survival with fewer side effects compared to IMRT. The study will track how well children function over five years, looking at:\n\n* Cognitive abilities (memory, attention, learning)\n* Hormonal balance (pituitary gland function)\n* Hearing ability\n* Overall survival without significant decline in quality of life\n\nHow will the study work?\n\n* Who can join? Children aged 6 to 16 years diagnosed with certain types of benign or low-grade brain tumors.\n* How are patients treated? Patients will be randomly assigned to receive either IMRT or IMPT.\n* What is analysed? Doctors will track survival, tumor control, cognitive function, endocrine health, and quality of life over time.\n* How long will it take? The study will last 10 years (5 years to enroll patients, 5 years to follow up).\n\nProton therapy is more expensive and not widely available, so strong scientific evidence is needed to justify its use in routine treatment. If IMPT significantly improves quality of life and survival, it could become the preferred treatment, shaping future policies and making proton therapy more accessible for children who need it.",[25],[195,196],"Brain tumor, Benign","Brain tumor, Pediatric",{"date":198,"type":38},"2026-01-30",{"date":200,"type":38},"2025-08-07",{"date":202,"type":19},"2035-07-07",{"name":204,"class":45},"Tata Memorial Centre",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":95,"enrollmentInfo":212,"targetDuration":4,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":230},"100539854","effectiveness-and-impact-on-the-quality-of-life-of-ketogenic-diet-in-pediatric-patients-100539854","NCT06309251","Effectiveness and Impact on the Quality of Life of Ketogenic Diet in Pediatric Patients","Clinical and Nutritional Effectiveness and Impact on the Quality of Life of the Ketogenic Diet in Pediatric Patients With Neurological, Genetic or Metabolic Disorders: a Multicenter Prospective Observational Study","Inclusion Criteria:\n\n* Pediatric patients (aged \\\u003C 18 years) with drug-resistant epilepsy (fail to achieve (and maintain) seizure freedom with adequate trials of two or more antiseizure medications) or genetic, metabolic, neurological (congenital and acquired) diseases treated with ketogenic diet\n* Pediatric patients (aged \\\u003C 18 years) with metabolic, genetic or neurological (congenital and acquired) diseases (not necessarily associated with drug-resistant epilepsy) treated with ketogenic diet; this includes the new KD indications or the administration of KD in the ICU for status epilepticus.\n\nExclusion Criteria:\n\n* Patients affected by beta-oxidation cycle disorders, systemic primary carnitine deficiency, primary dyslipidemia, pyruvate carboxylase deficiency, porphyria, mitochondrial disease, defects in ketone body metabolism (ketogenesis or ketolysis), defect in gluconeogenesis.\n* Children with type 1 diabetes\n* Parents (or caregivers) unable to guarantee adherence to the",{"count":213,"type":19},100,"OBSERVATIONAL","The goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (KD) in pediatric patients with genetic, neurological or metabolic conditions requiring KD.\n\nThe main question\\[s\\] it aims to answer are:\n\n* does KD support adequate growth?\n* does KD improve clinical symptoms?\n* how does KD impact quality of life? Participants will be followed up as per clinical practice",[217,218,219,25],"Drug Resistant Epilepsy","Autism Spectrum Disorder","Chronic Migraine","2025-08-26",{"date":222,"type":38},"2025-09-03",{"date":224,"type":38},"2022-03-01",{"date":226,"type":19},"2026-12-31",{"name":228,"class":229},"Danone Nutricia SpA Società Benefit","INDUSTRY",3,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":15,"minAge":238,"maxAge":239,"enrollmentInfo":240,"targetDuration":4,"studyType":20,"phases":242,"briefSummary":243,"conditions":244,"keywords":249,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":46},"100462233","phase-1-gd2-car-t-cells-for-pediatric-brain-tumours-100462233","NCT05298995","GD2-CAR T Cells for Pediatric Brain Tumours","Phase I Study of Anti-GD2 Chimeric Antigen Receptor-Expressing T Cells in Pediatric and Young Adult Patients Affected by Relapsed\u002FRefractory Central Nervous System Tumors","Inclusion Criteria:\n\n1. Imaging assessments performed within 14 days of start of treatment\n2. Age: 6months-30years\n3. Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment\n4. Karnofsky\u002FLansky≥60\n5. Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence of chronic complications (i.e. treatment-associated thrombocytopenia), patient must be clinically stable, according to the opinion of the treating physicians, and meet all other eligibility criteria\n6. Positioning of an implantable intraventricular access device (CodmanHolterRickham reservoir, Integra LifeSciences, NJ, U.S.A) and a microdialysis probe (71 high cutoff microdialysis bolt catheter, M Dialysis AB, Stockholm Sweden)\n7. Written and signed informed consent from patients, parents or legal guardians. For subjects \\\u003C 18 year-old their legal guardian must give informed consent. In addition, pediatric subjects will be included in age-appropriate discussion and written informed assent will be obtained for those greater than or equal to 7 years of age, when appropriate\n8. Patients of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen\n9. Females of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Severe,uncontrolledactiveinfections\n3. HIV or active HCV and\u002For HBV infection\n4. Rapidly progressive disease with life expectancy \\\u003C 6 weeks\n5. Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts\n6. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN based on age and laboratory specific normal ranges\n7. Renal function: serum creatinine \\> 3x ULN for age\n8. Blood oxygen saturation \\\u003C 90%\n9. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO\n10. Marrow function: absolute neutrophils count (ANC) lower than 500\u002Fmm3 and\u002For platelets lower than 20.000 (not reached by transfusion)\n11. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable risk to the subject. 12.Concurrent or recent prior therapies, before infusion:\n\n    1. If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon- absorbable steroids is not exclusionary. Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\n    2. Systemic chemotherapy in the 3 weeks preceding infusion\n    3. Immunosuppressive agents less than or equal to 30 days\n    4. Radiation therapy must have been completed at least 6 weeks prior to enrollment\n    5. Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy\n\n13.Patient-derived GD2-CART01 production failure: vitality \\\u003C80%, CD3+ cells \\\u003C80%, CD3+ CAR+ cells \\\u003C20%, CD3+ CAR+ antitumor activity \\\u003C60% in functional co-culture assay at an Effector: Target ratio 1:1, viable CAR+ cells upon AP1903 exposition \\>20%, RCR positivity, Vector Copy Number \\>10, non-sterility, endotoxin contamination (\\> 1 EU\u002Fml)","6 Months","30 Years",{"count":241,"type":19},54,[151],"The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed\u002Frefractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.",[25,158,245,246,247,248,156],"Embryonal Tumor","High Grade Glioma","Diffuse Midline Glioma","Diffuse Intrinsic Pontine Glioma",[250,251,252,247,248,253,254,255,256,257],"Brain tumors","high grade glioma","medulloblastoma","CAR T cell","GD2-antigen","Immunotherapy","Pediatric Central Nervous System tumours","Central nervous system tumour young adults","2025-02-03",{"date":260,"type":38},"2025-02-05",{"date":262,"type":38},"2023-11-09",{"date":264,"type":19},"2038-11",{"name":266,"class":45},"Bambino Gesù Hospital and Research Institute",{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":15,"minAge":274,"maxAge":147,"enrollmentInfo":275,"targetDuration":4,"studyType":20,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":4},"100523249","re-irradiation-of-diffuse-midline-glioma-patients-100523249","NCT06093165","RE-irradiation of Diffuse MIdline Glioma paTients","REMIT","Inclusion Criteria:\n\n* Diffuse midline glioma diagnosis: verified radiologically or histologically Biopsy is not mandatory for REMIT\n* Age ≥ 12 months to ≤21 years.\n* Min. 180 days\u002F6 months have elapsed from the first day of the 1st RT course\n* 1st course of radiotherapy\n* Full recovery from all acute and subacute toxicities of 1st RT course\n* Clinical progression of symptoms and\u002For radiographic progression\n* Karnofsky performance status scale or Lansky Play Scale \\> 50% The performance status should not take the neurological deficits per se into account.\n\nNB: Children and adults with a worsening performance status due to glioma-related motor deficit can be included.\n\n* Life expectancy \\> 12 weeks after start of reRT\n* Signed informed consent by patient and\u002For parents or legal guardian\n\nExclusion Criteria:\n\n* Presence of leptomeningeal spread or multifocal disease on MRI at progression\n* Other co-morbidity that according to the treating physician would impair participation in the study\n* \\>1 course of radiotherapy\n* Neurofibromatosis type 1\n* Inability to complete the medical follow-up (geographic, social, or mental reasons)","12 Months",{"count":276,"type":19},59,[22],"The REMIT (RE-irradiation of diffuse MIdline glioma paTients) study evaluates safety and the palliative efficacy of re-irradiation of patients with diffuse midline glioma (DMG). The study will introduce a standard re-irradiation treatment schedule for DMG patients who have progressed following primary treatment.",[280,248,281,282,283,25],"Diffuse Midline Glioma, H3 K27M-Mutant","Diffuse Glioma","Pontine Tumors","Thalamic Tumor","2023-10-16",{"date":286,"type":38},"2023-10-23",{"date":288,"type":19},"2023-10",{"date":290,"type":19},"2029-11",{"name":292,"class":45},"Rigshospitalet, Denmark",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":15,"minAge":301,"maxAge":95,"enrollmentInfo":302,"targetDuration":304,"studyType":214,"phases":4,"briefSummary":305,"conditions":306,"keywords":310,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":46},"100490893","genetic-and-molecular-risk-profiles-of-pediatric-malignant-brain-tumors-in-china-100490893","NCT05672043","Genetic and Molecular Risk Profiles of Pediatric Malignant Brain Tumors in China","Perspective Study on Genetic Predispositions and Clinical Prognosis of Children and Adolescents With Malignant Brain Neoplasms in China","GRIPP","Inclusion Criteria:\n\n\\- Children and adolescents aged between 0-18 years old, diagnosed with medulloblastoma or other malignant central nervous system tumors including glioma, ependymoma, germ cell tumors,tuberous sclerosis, neuronal and neuronoglial tumors, choroid plexus tumors, atypical teratoid\u002Frhabdoid tumors, ependymoblastoma, and medulloepithelioma;\n\nPatients must be eligible for and receive tumor resection;\n\nHistological examination by institutional neuro-pathological evaluation must confirmed the diagnosis of brain malignancies;\n\nParticipants consent with joining the current study and comply with follow-up visits;\n\nThe patients must have no previous radiotherapy or chemotherapy other than corticosteroids.\n\nExclusion Criteria:\n\n\\- Patients with major perioperative complications which lead to significant and sudden deterioration;\n\nPatients with major systemic illness (e.g., serious infection or significant cardiac, pulmonary, hepatic, or other organ dysfunction) which might compromise the patient's ability to tolerate standard treatment or would likely interfere with overall prognosis;\n\nPatients with major adverse events or sudden deterioration irrelevant to the current study;\n\nQuality of tumor tissue sample did not meet the criterion for genetic sequencing and laboratory investigations;\n\nPatients who refuse to participate in the study or who request dropping out from the study","0 Years",{"count":303,"type":19},400,"5 Years","Primary malignant central nervous system (CNS) tumors are the second most common childhood malignancies. Amongst, medulloblastomas are the most common malignant brain tumor of childhood and occur primarily in the cerebellum. According to molecular characteristics, medulloblastomas were classified into four subtypes: WNT, SHH, Group3 and Group4 and different prognosis were noticed between subgroups. Several genetic predispositions related to clinical outcome were also discovered and might influence the treatment of medulloblastomas as novel pharmaceutical targets. This study aims to investigate genetic and cellular profiles of pediatric brain malignancies, mostly medulloblastomas, and other central nervous system tumor based on WGS, RNA-seq, single-cell sequencing and spatial transcriptomics. We also aim to investigate the correlation between genetic characteristics and clinical prognosis.",[157,307,161,308,309,25],"Central Nervous System Tumor, Pediatric","Germ Cell Tumor","Glioma",[252,75],"2023-01-03",{"date":313,"type":38},"2023-01-05",{"date":315,"type":38},"2023-01-01",{"date":317,"type":19},"2032-12-31",{"name":319,"class":45},"Beijing Tiantan Hospital"]