[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioma-high-grade\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioma-high-grade":105},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,79],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100636554",false,"NCT07567196","PET-Guided Resection in High-Grade Gliomas","ResPGlioma: Impact of PET-Guided Resection on Survival in High-Grade Gliomas - A Multicenter Prospective Study","ResPGlioma","Inclusion Criteria:\n\n* age ≥18 years\n* high-grade glioma (WHO grade III\u002FIV) diagnosed on MRI\n* provide written informed consent\n\nExclusion Criteria:\n\n* tumors located in the cerebellum, brainstem, or midline.\n* Patients with medical conditions precluding MRI\n* inability to provide written informed consent\n* secondary high-grade gliomas resulting from malignant transformation of a low-grade glioma\n* other primary malignancy within the past five years","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","Background: Glioblastoma (GBM) is the most common primary brain tumor in adults, with a poor prognosis despite maximal treatment. Current evidence suggests that supramaximal resection, including non-enhancing FLAIR-hyperintense regions, improves survival. However, the extent of FLAIR resection is often limited by functional constraints and its non-specific nature, as it may represent both tumor infiltration and peritumoral edema. This study explores the role of 18F-DOPA PET in refining supramaximal resection by providing a more specific surgical target beyond contrast-enhancing areas.\n\nObjective: To evaluate the impact of 18F-DOPA PET-guided resection on progression-free survival (PFS) and overall survival (OS) in GBM patients, by comparing outcomes between those undergoing PET-RM integrated resection versus conventional MRI-guided resection.\n\nMethods: ResPGlioma is a multicenter, prospective, non-randomized study conducted at IRCCS Ospedale Policlinico San Martino (Genoa) and AOU Città della Salute e della Scienza (Turin). Patients with newly diagnosed, supratentorial, high-grade gliomas undergo preoperative 18F-DOPA PET and MRI. Surgery follows the principle of maximal safe resection, with postoperative MRI at 48 hours assessing the extent of resection (EOR). To confirm PET resection or non-PET resection status, patients will undergo a postoperative 18F-DOPA PET scan at 30 ± 7 days following surgery, prior to the initiation of chemoradiotherapy. Patients are categorized based on EOR criteria (RANO) and PET volume resection (PET-resection vs. PET non-resection). Statistical analyses include Kaplan-Meier survival curves and regression models to identify prognostic factors.Patients are categorized based on EOR criteria (RANO) and PET volume resection (PET-resection vs. PET non-resection). Statistical analyses include Kaplan-Meier survival curves and regression models to identify prognostic factors.\n\nExpected Outcomes: The authors hypothesize that PET-guided resection improves PFS and OS by enabling a more precise tumor removal beyond contrast-enhancing margins while preserving neurological function. Preliminary data support that PET hypercaptant areas contain viable tumor cells and should be resected. This approach may offer a more accessible yet effective alternative to FLAIR-guided supramaximal resection.",[24,25,26,27],"Glioma Glioblastoma Multiforme","Glioma, High Grade","Glioma Surgery","Positron-Emission Tomography(PET)",[29,30,31],"glioma","glioblastoma","PET","RECRUITING","2026-04-27",{"date":35,"type":36},"2026-05-05","ACTUAL",{"date":38,"type":36},"2022-04-01",{"date":40,"type":20},"2029-12-31",{"name":42,"class":43},"Universita degli Studi di Genova","OTHER",2,{"id":46,"slug":4,"hasResults":10,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100629163","NCT07471100","Neuromodulation-Induced Cortical Prehabilitation in High Grade Glioma Near the Motor Pathway: Cortical Plasticity Assessed by Navigated Transcranial Magnetic Stimulation (nTMS)","Neuromodulation-Induced-Cortical-Prehabilitation In High Grade Glioma Close To The Motor Pathway: Analysis Of The Cortical Brain Plasticity Through Navigated Transacranial Magnetic Stimulation","Inclusion Criteria:\n\n1. Age 18-80\n2. Suspect of High Grade Glioma in MRI\n3. Any case of cortical\u002Fsubcortical HGG radiologically close to Motor Pathway and, thus, where intraoperative monitoring assistance is usually required\n4. Preservation of motor function (at least ≥ 3 according to Medical Research Council classification)\n5. Signed informed Consent\n\nExclusion Criteria:\n\n1. Refusal to Study participation\n2. Multifocal\u002FBilateral Disease","80 Years",{"count":53,"type":20},63,"INTERVENTIONAL",[56],"NA","The goal of this clinical trial is to learn whether Neuromodulation-Induced-Cortical-Prehabilitation (NICP)-using physical therapy (constraint-induced movement training, CIM) alone or combined with repetitive transcranial magnetic stimulation (rTMS)-can promote motor-cortex neuroplasticity before surgery in adults with high-grade gliomas near the motor pathway. It will also learn about the feasibility and safety of these prehabilitation strategies around the time of surgery. The main questions it aims to answer are:\n\n1. Does CIM (with or without rTMS) produce measurable motor-cortex plasticity from baseline to pre-surgery as assessed by neuronavigated TMS (nTMS)?\n2. Does adding rTMS to CIM lead to greater neuroplastic changes than CIM alone?\n3. What clinical, radiological, and neurophysiological outcomes are observed after surgery in participants who receive prehabilitation compared with controls?\n\nResearchers will compare standard care (control) vs CIM-based physical therapy vs CIM plus rTMS to see if these approaches induce preoperative neuroplastic changes that may support better surgical outcomes. Participants will:\n\n1. Be randomized to one of three groups: control, CIM physical therapy, or CIM + rTMS• Undergo nTMS motor mapping and excitability testing at baseline (T0) and the day before surgery (T1)\n2. Undergo planned tumor surgery (according to standard methods of care) and complete postoperative clinical, imaging, and neurophysiological follow-up assessments.",[59,60,25],"Brain Tumor Adult","Glioma",[62,63,64,65,66,67,68],"prehabilitation","neuromodulation","brain plasticity","cortical plasticity","rTMS","nTMS","physical therapy","NOT_YET_RECRUITING","2026-03-11",{"date":72,"type":36},"2026-03-13",{"date":74,"type":20},"2026-04-01",{"date":76,"type":20},"2030-03-31",{"name":78,"class":43},"Azienda Sanitaria dell'Alto Adige",{"id":80,"slug":4,"hasResults":10,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":10,"sex":16,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":54,"phases":88,"briefSummary":90,"conditions":91,"keywords":92,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100616491","NCT07306299","A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma","An Exploratory Phase I Clinical Trial of a Universal mRNA Vaccine for Recurrent or Progressive High-grade Glioma","Inclusion Criteria:\n\n1. Adequate compliance, ability to comprehend the clinical trial, and provision of written informed consent.\n2. Male or female, aged ≥16 years.\n3. Histologically or cytologically confirmed WHO Grade III or IV glioma harboring one or more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII.\n4. Recurrent or progressive high-grade glioma, defined as a CNS WHO Grade 3-4 glioma confirmed by post-surgical histopathology, with documented recurrence or progression per RANO criteria on MRI following standard therapy (radiotherapy plus temozolomide chemotherapy).\n5. Life expectancy ≥3 months.\n6. Karnofsky Performance Status (KPS) ≥50. For subjects with spinal cord lesions, functional deficits due to paralysis will not be considered in the KPS assessment.\n7. Absence of significant bone marrow, cardiac, pulmonary, or renal dysfunction, defined as:\n\n   1. Hematologic (without transfusion or hematopoietic growth factor support within 14 days):\n\n      * Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹\u002FL\n      * Platelet count (PLT) ≥100 × 10⁹\u002FL\n      * Hemoglobin (HGB) ≥90 g\u002FL\n   2. Hepatic Function:\n\n      * Alanine Aminotransferase (ALT) ≤2.5 × Upper Limit of Normal (ULN)\n      * Aspartate Aminotransferase (AST) ≤2.5 × ULN\n      * Total Bilirubin (TBIL) ≤1.5 × ULN\n   3. Renal Function:\n\n      \\* Serum creatinine ≤1.5 × ULN OR estimated creatinine clearance ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   4. Coagulation:\n\n      * Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN\n      * International Normalized Ratio (INR) ≤1.5 × ULN\n   5. Other:\n\n      * Left Ventricular Ejection Fraction (LVEF) ≥50% without clinically significant pericardial effusion on echocardiogram\n      * No clinically significant electrocardiogram (ECG) abnormalities\n      * Baseline oxygen saturation \\>92% on room air\n8. Adequate immune function, defined as receiving dexamethasone ≤2 mg\u002Fday within the 3 days prior to screening without severe lymphopenia.\n9. Negative pregnancy test for women of childbearing potential (WOCBP); non-pregnant and non-lactating females; both male and female participants must agree to use highly effective contraception and have no plan for pregnancy within 6 months after study entry.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past 5 years (except appropriately treated carcinoma in situ of the cervix or non-melanoma skin cancer).\n2. History of hypersensitivity to chemotherapy agents or radiosensitizers used for central nervous system or head and neck cancers.\n3. History of severe allergic reactions to vaccines or any components of the investigational product.\n4. Positive serology for:\n\n   * Human Immunodeficiency Virus (HIV) antibody\n   * Hepatitis C Virus (HCV) antibody with detectable HCV RNA\n   * Hepatitis B Surface Antigen (HBsAg) with HBV DNA ≥2000 IU\u002FmL\n   * Treponema pallidum (TP) antibody with a positive confirmatory test (e.g., RPR\u002FTPPA)\n5. Active, uncontrolled infection, active tuberculosis, or active immunosuppressive disease.\n6. Any concurrent non-malignant illness or psychiatric condition that would preclude safe protocol participation; uncontrolled cardiovascular disease (e.g., coronary artery disease, angina, myocardial infarction, significant arrhythmias).\n7. Inability or unwillingness to provide informed consent or participate voluntarily.\n8. Concurrent participation in another interventional clinical trial or participation within 3 months prior to screening.\n9. Severe infection or signs\u002Fsymptoms of active infection within 2 weeks prior to the first dose of the investigational product.\n10. Administration of a live-attenuated vaccine within 4 weeks prior to the first dose.\n11. History of solid organ or hematopoietic stem cell transplantation.\n12. Any other condition that, in the opinion of the investigator, would jeopardize the subject's safety or compliance with the study protocol.","16 Years",{"count":87,"type":20},10,[89],"PHASE1","This clinical trial is designed to evaluate the safety and efficacy of a universal mRNA vaccine targeting a panel of glioma-associated mutations in patients with recurrent or progressive high-grade glioma.\n\nThe primary objectives are to address the following key questions: 1) Is the mRNA vaccine safe for this patient population? 2) Does the vaccine stimulate an anti-tumor immune response and promote tumor regression?\n\nParticipants will receive the vaccine according to the following schedule:\n\n1. one injection per week for four consecutive weeks, followed by one injection every four weeks for four cycles, and subsequently, one injection every 12 weeks for maintenance.\n2. Safety and efficacy assessments, including detailed recording of adverse events and tumor growth evaluation, will be conducted at follow-up visits scheduled for weeks 6, 12, and months 6, 9, 12, 18, 24, and 36 post-treatment initiation.",[25],[60,93,94],"mRNA vaccine","Mutation","2025-12-14",{"date":97,"type":36},"2025-12-29",{"date":99,"type":36},"2025-12-01",{"date":101,"type":20},"2031-01-01",{"name":103,"class":43},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1,""]