[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-tumor-primary\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-tumor-primary":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,51,73,100,123,143,181,207,235,258,278,301,324],{"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":27,"conditions":28,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121",false,"NCT03213002","Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM","Phase I\u002FII Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed Glioblastoma (GBM)","CAPTEM","Inclusion Criteria:\n\n1. Be capable of giving informed consent.\n2. Have a pathology proven diagnosis of any of newly diagnosed Glioblastoma Multiforme WHO IV\n3. Have completed the first part of standard of care chemo-radiation (Stupp), for 6 weeks, and not started the maintenance phase of temozolomide\n4. Agree to use effective barrier contraception while on treatment and for 2 months thereafter, if of childbearing potential\n5. Have a life expectancy \\> 3 months\n6. Be between the ages of 18 to 74\n7. Have a performance status KPS 70 or greater\n8. Be able to swallow pills and capsules\n9. Be able to tolerate oral chemotherapeutic medications, with no health threatening allergies or side effects, based on lab and clinical findings\n10. Have adequate bone marrow function, liver function and renal function before commencing therapy\n\nExclusion Criteria:\n\n1. Prior chemotherapy with capecitabine or temozolomide for other prior malignancies. Patients previously treated with continuous infusion 5-FU or any schedule of DTIC, which are similar to capecitabine and temozolomide, respectively, will be excluded.\n2. Prior chemotherapies for newly diagnosed GBM or AA, other than temozolomide during radiation.\n3. Patients with a history of severe hypersensitivity reaction to capecitabine, 5-FU, temozolomide (i.e. anaphylaxis or anaphylactic reactions),\n4. Serious medical or psychiatric illness preventing informed consent or treatment (e.g., serious infection)\n5. Prior malignancies in the last 5 years other than curatively treated carcinoma in-situ previously treated with curative intent (cancer free for the past one year).\n6. Performance status, KPS \\\u003C 70\n7. Inability to swallow pills and capsules\n8. Concurrent chemotherapy or treatment for the active disease, including devices such as Optune, high dose vitamin supplements, or any other chemotherapy\n9. Patients taking concomitant medications such as Coumadin and phenytoin medications, need to be excluded because of interactions with capecitabine\n10. Patients with previously documented CAD will need to be evaluated by cardiology prior to start to help risk stratify for capecitabine tolerance\n11. Patients with renal insufficiency or hepatic insufficiency\n12. Patients with coagulopathies\n13. Women who are pregnant or lactating.","ALL","18 Years","74 Years",{"count":21,"type":22},67,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).\n\nCapecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg\u002Fm2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.",[29,30,31,32,33,34,35,36,37],"Glioblastoma Multiforme (GBM)","Glioblastoma","Glioma of Brain","Glioblastoma, Adult","Brain Tumor","Brain Tumor, Primary","Brain Tumor Adult","Cancer","Brain Cancer","RECRUITING","2026-05-28",{"date":41,"type":42},"2026-06-01","ACTUAL",{"date":44,"type":42},"2017-06-13",{"date":46,"type":22},"2029-06",{"name":48,"class":49},"Northwell Health","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":50},"100610352","evaluating-biomarkers-of-cognitive-dysfunction-in-patients-with-cancer-100610352","NCT07226466","Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer","Inclusion Criteria:\n\n1. \\>= 18 years old\n2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.\n3. Diagnosis of primary solid tumor and secondary involvement of the brain\n4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \\> 1 cm in max diameter.\n5. Candidate for standard of care \u002F usual care (SOC) focused brain radiotherapy.\n6. No prior brain radiotherapy, including whole brain radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.\n8. Estimated life expectancy post-treatment of \\> 2 years.\n\nExclusion Criteria:\n\n1. Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).\n2. Diagnosis of memory disorder pre-treatment.\n3. Leptomeningeal disease or disease involving either hippocampus.",{"count":58,"type":22},40,"OBSERVATIONAL","This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.",[35,62,34,33],"Brain Metastases From Solid Tumors","NOT_YET_RECRUITING","2026-05-20",{"date":66,"type":42},"2026-05-22",{"date":68,"type":22},"2026-07-01",{"date":70,"type":22},"2028-10-31",{"name":72,"class":49},"University of California, San Francisco",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":80,"targetDuration":82,"studyType":59,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":99},"100395308","registry-of-patients-with-brain-tumors-treated-with-start-gammatiles-100395308","NCT04427384","Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)","A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms","Inclusion Criteria:\n\n1. Patients who undergo maximum safe resection of intracranial neoplasm(s) AND implantation of GammaTiles.\n2. Willing and able to provide informed consent and to participate in all evaluations.\n\nExclusion Criteria:\n\n1. Inability to undergo pre-operative and post-operative imaging for disease and implant assessment.\n2. Major medical or psychiatric illness, which, in the investigator's opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and\u002For interfere with follow ups.\n3. Subjects who, in the investigator's opinion, are unable to understand the protocol or to give informed consent, have a history of poor cooperation, noncompliance with medical treatment, or difficulty in returning for follow up care. A legally authorized representative may provide consent if the potential subject lacks the capacity to provide consent themselves.",{"count":81,"type":22},600,"5 Years","The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.",[85,33,34,86,87,88],"Brain Tumor, Recurrent","Brain Tumor - Metastatic","Brain Tumor, Adult: Glioblastoma","Brain Tumor, Adult Meningioma","2026-02-11",{"date":91,"type":42},"2026-02-13",{"date":93,"type":42},"2020-09-11",{"date":95,"type":22},"2028-12-31",{"name":97,"class":98},"GT Medical Technologies, Inc.","INDUSTRY",54,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":82,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":4},"100613241","correlation-between-nutritional-status-of-childhood-neurological-tumors-and-quality-of-life-100613241","NCT07264023","Correlation Between Nutritional Status of Childhood Neurological Tumors and Quality of Life","A Prospective, Observational, Multicenter Longitudinal Cohort Study on the Correlation Between Nutritional Status and Quality of Life in Children With Neuro-oncological Tumors During the Peri-radiotherapy Period.","Inclusion Criteria:\n\n* The patient and the legal guardian have agreed to sign the informed consent form;\n* Age ≥ 5 years old and ≤ 18 years old;\n* The pathological or clinical diagnosis is a neurological tumor;\n* Patient has indications for radiotherapy;\n* The expected survival time is over 6 months.\n\nExclusion Criteria:\n\n* Accompanied by other serious complications;\n* The researcher judged that it was not suitable to participate in this study.",{"count":108,"type":22},93,"Maintaining good nutritional status during treatment for children with cancer is crucial for many outcomes, such as overall survival rate, tolerance to treatment, susceptibility to infection, and quality of life. Neurotumors in children account for the highest proportion among solid tumors in children. Previous studies have clearly shown that neurotumors in children have different nutritional characteristics from hematological tumors and other solid tumors in children. Our retrospective data found that there was a significant correlation between the BMI Z values of children with neurotumors before and during radiotherapy and the frequency of adverse events. The occurrence of adverse events has a negative impact on the quality of life of child patients. Therefore, we plan to conduct a prospective, observational, multi-center longitudinal cohort study to evaluate the dynamic changes in nutritional status during the peri-radiotherapy period, explore the correlation between nutritional status and quality of life in children with neurotumors before and after radiotherapy, and establish a nutritional management plan and nutritional risk early warning model suitable for Chinese children with neurotumors.",[111,112,113,34],"Nutritional Status","Quality of Life","Children","2025-12-14",{"date":116,"type":42},"2025-12-16",{"date":118,"type":22},"2025-12-15",{"date":120,"type":22},"2027-05-31",{"name":122,"class":49},"Nanfang Hospital, Southern Medical University",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":50},"100476185","circulating-biomarkers-repository-in-adults-diagnosed-with-primary-and-metastatic-brain-tumors-100476185","NCT05480644","Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors","Inclusion Criteria:\n\n* Have a confirmed diagnosis of primary or metastatic brain tumor (histology or imaging as appropriate)\n\nExclusion Criteria:\n\n* None",{"count":130,"type":22},300,"The purpose of this protocol is to create a repository of blood samples from patients diagnosed with primary and metastatic brain tumors who are being seen in the Department of Radiation Oncology at Duke Cancer Center.",[34,133],"Brain Metastases, Adult","2025-11-18",{"date":136,"type":42},"2025-11-19",{"date":138,"type":42},"2022-12-01",{"date":140,"type":22},"2032-12",{"name":142,"class":49},"Duke University",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":161,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":50},"100606728","phase-1-focused-ultrasound-blood-brain-barrier-disruption-for-the-treatment-of-high-grade-glioma-in-patients-undergoing-standard-chemotherapy-100606728","NCT07179328","Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Assessment of Safety and Feasibility of Focused Ultrasound Next Generational Dome Helmet Mediated Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Inclusion Criteria:\n\n1. Age between 18 and 85 years, inclusive.\n2. Able and willing to provide written informed consent.\n3. Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.\n4. Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.\n5. Tumor or tumor resection cavity is clearly defined on screening MRI scans.\n6. Karnofsky Performance Score rating 70-100.\n7. American Society of Anesthesiologists (ASA) physical status score of 1-3.\n8. Life expectancy of at least 3 months and able to attend all study visits.\n\nExclusion Criteria:\n\n1. Patients presenting with the following imaging characteristics:\n\n   i. Following steroid treatment, brain edema and\u002For mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm.\n\n   ii. Evidence of recent (less than 2 weeks) intracranial hemorrhage. iii. Calcifications in the FUS sonication beam path in the event system tools cannot tailor the treatment around these calcification spots.\n2. The sonication pathway to the tumor involves:\n\n   i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.\n\n   ii. Clips or other metallic implanted objects in the skull or the brain, except shunts.\n3. The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).\n4. Patients requiring increasing doses of corticosteroids.\n5. Patient receiving bevacizumab (Avastin) therapy.\n6. Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative MRI. This cut-off is used to differentiate between pseudoprogression (which can occur following both radiation and TMZ therapy) and true tumor progression. This will be further ascertained through a discussion between the study neurosurgeons and radiologists.\n7. Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence.\n8. Cardiac disease or unstable hemodynamics including:\n\n   i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \\\u003C50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.\n9. Severe hypertension (diastolic blood pressure (DBP) \\> 100 on medication).\n10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).\n11. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.\n12. Abnormal level of platelets (\\\u003C 100,000) or INR \\> 1.3.\n13. Documented cerebral infarction within the past 12 months.\n14. TIA in the last 1 month.\n15. Cerebral or systemic vasculopathy.\n16. Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.\n17. Known sensitivity to gadolinium-DTPA.\n18. Known sensitivity to DEFINITY® ultrasound contrast agent or perflutren.\n19. Contraindications to MRI such as non-MRI-compatible implanted devices, unable to tolerate an MRI due to for instance pain or claustrophobia, untreated, uncontrolled sleep apnea.\n20. Positive pregnancy test (for pre-menopausal women).\n21. Known life-threatening systemic disease.\n22. Severely impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 and\u002For on dialysis.\n23. Right to left or bi-directional cardiac shunt.\n24. Previous full course of chemotherapy for GBM (at the discretion of investigator).\n25. Previous radiotherapy.\n26. Allergy to eggs or egg products.\n27. Subjects with evidence of cranial or systemic infection.\n28. Subjects with chronic pulmonary disorders.\n29. Subjects with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular subjects with a history of anaphylaxis.\n30. Subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation, or QT prolongation observed on screening ECG (QTc \\> 450 for men and \\>470 for women).\n31. Subjects with evidence of Hepatitis B virus infection\u002Fcarrier state.\n32. Liver injury as indicated by liver function tests that in the Investigator's opinion precludes participation in the study.","85 Years",{"count":152,"type":22},10,[25],"The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard \"Stupp protocol\".\n\nParticipants will:\n\n* Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy.\n* Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption.\n* Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening.\n* Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response.\n* Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.",[156,29,157,158,159,160,35,34],"GBM","Glioblastoma Multiforme of Brain","Glioblastoma Multiforme Glioma","HGG","Glioma",[162,163,156,164,165,166,167,168,169,170,171],"Focused Ultrasound","FUS","TMZ","Temozolomide","blood-brain barrier disruption (BBBD)","MR-guided Focused Ultrasound (MRgFUS)","Glioblastoma multiforme","blood-brain barrier opening","Drug delivery","Chemotherapy delivery","2025-09-10",{"date":174,"type":42},"2025-09-17",{"date":176,"type":42},"2025-06-04",{"date":178,"type":22},"2027-11",{"name":180,"class":49},"Sunnybrook Health Sciences Centre",{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":17,"minAge":188,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":192,"conditions":193,"keywords":194,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":50},"100530354","radiation-induced-alterations-in-resting-state-brain-networks-in-pediatric-brain-tumor-patients-100530354","NCT06185686","Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients","Assessing Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients","Inclusion Criteria:\n\n* Between 8 and 21 years of age, inclusive\n* Newly diagnosed primary brain tumor of any location and any histology that will be treated with proton radiation therapy\n* Life expectancy of at least one year\n* Able to understand and willing to consent or assent to the research proposed (or that of a legally authorized representative, if applicable), along with consent of legal guardian(s) if applicable\n\nExclusion Criteria:\n\n* Presence of visual impairment to an extent that the patient is unable to complete the computer testing\n* Contraindication to MRI scan (i.e. due to cardiac pacemaker)\n* Presence of programmable shunt or dental braces\n* Requires sedation for MRI scans","8 Years","21 Years",{"count":191,"type":22},16,"With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.",[34],[195,196,197],"Proton therapy","Radiation","Brain tumor","2025-07-15",{"date":200,"type":42},"2025-07-18",{"date":202,"type":42},"2024-07-10",{"date":204,"type":22},"2027-07-31",{"name":206,"class":49},"Washington University School of Medicine",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":217,"studyType":59,"phases":4,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100595771","3d-decision-support-tool-for-brain-tumour-surgery-development-and-validation-observational-study-100595771","NCT07036783","3D Decision Support Tool for Brain Tumour Surgery Development and Validation: Observational Study","Multimodal Data Collection for the Development and Validation of the STRATUM Tool to Assist Surgery in Patients Affected by Brain Tumours: Observational Study","STRATUM-OS","Inclusion Criteria:\n\n* Adult patients (≥18 y\u002Fo).\n* Patients with planned surgery for suspected intraaxial malignant brain tumours (both primary and secondary) at any of the participating clinical institutions.\n\nExclusion Criteria:\n\n* Inability to deliver informed consent (unless provided by the tutor).\n* Participants in this study who have already undergone brain surgery during STRATUM-OS and need a revision surgery.",{"count":216,"type":22},320,"6 Months","This observational study (STRATUM-OS) aims to collect the necessary data from a cohort of patients with planned surgery for suspected intra-axial malignant brain tumours (both primary and secondary) following the standard surgical procedure established in current clinical protocols. These data will serve two primary purposes:\n\ni) To gather multimodal data (pre, intra and postoperative) essential for the development and technical validation of a 3D decision support tool for brain surgery guidance and diagnostics integrating augmented reality and multimodal data processing powered by artificial intelligence algorithms (called STRATUM tool);\n\nii) To collect outcome measures that will facilitate a subsequent comparative study (a non-randomized controlled clinical trial, called STRATUM-NRCCT) assessing the standard procedure alone versus the standard procedure augmented with the STRATUM tool. Patients from STRATUM-OS will act as a historical control group in the subsequent historically controlled clinical trial (STRATUM-NRCCT), which will be performed once STRATUM-OS has been completed.\n\nIn STRATUM-OS patients will receive standard care as per established clinical protocols, with no modification to their treatment. However, patients will be asked to grant access to their clinical information, complete questionnaires, and provide relevant pre, intra and postoperative information related to the surgical intervention. Data will be gathered from multiple sources, such as the Electronic Health Records (EHR), patient completed questionnaires, interviews, and reports from healthcare professionals involved in the surgical procedure. Additionally, intraoperative data will be collected from the different devices in the operating room.",[220,34],"Brain (Nervous System) Cancers",[222,223,224,225],"Hyperspectral Imaging","Brain Tumour","Neurosurgery","Multimodal imaging","2025-06-17",{"date":228,"type":42},"2025-06-25",{"date":230,"type":22},"2025-07-01",{"date":232,"type":22},"2027-04-30",{"name":234,"class":49},"Fundación Canaria Instituto de Investigación Sanitaria de Canarias",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":50},"100503159","characterization-of-circulating-and-tumor-infiltrating-immune-cells-in-malignant-brain-tumors-100503159","NCT05831631","Characterization of Circulating and Tumor-infiltrating Immune Cells in Malignant Brain Tumors","Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.","Inclusion criteria:\n\n* Adult patients (≥18 years)\n* Able to express informed consent\n* With primary or secondary malignant brain tumor\n* Requiring neurosurgical treatment (radiosurgery, stereotactic biopsy, surgery)\n\nExclusion Criteria:\n\n* Patients who do not meet inclusion criteria.",{"count":243,"type":22},200,"The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome.\n\nParticipants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.",[34,86],[247,248],"Immunophenotype","Primary and secondary brain tumor","2025-06-06",{"date":251,"type":42},"2025-06-11",{"date":253,"type":42},"2022-08-01",{"date":255,"type":22},"2029-08-01",{"name":257,"class":49},"Pietro Mortini, MD, Prof.",{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":50},"100498838","glutamate-excitotoxicity-and-its-role-in-glioblastoma-biology-100498838","NCT05775458","Glutamate Excitotoxicity and Its Role in Glioblastoma Biology","Role of Glutamate-mediate Excitotoxicity in Invasion and Progression Processes of Glioblastoma Multiforme","Inclusion Criteria:\n\n* Adult patients with a brain lesion suspected for GBM, candidate to gross total tumor resection (GTR), followed by radiotherapy and chemotherapy (concomitant and adjuvant).\n* Patient able to provide informed consent.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Liver disease\n* Severe anemia (Hb \\\u003C8mg\u002Fdl)\n* Pregnancy",{"count":266,"type":22},50,"Gliomas are the most frequent type of primary brain tumors in adults; among them glioblastoma multiforme (GBM) is the most malignant, being associated with the worst prognosis. Glutamate (Glu) is an aminoacid, responsible for essential functions in the Central Nervous System (CNS), acting both as metabolite and neurotransmitter. It is essential for regulating cellular metabolism and developmental synaptogenesis, cellular migration, differentiation and death. Recent scientific evidences have demonstrated alteration in Glu synthesis and signaling being directly involved in GBM growth and invasion",[34],[197,270],"Glutamate",{"date":251,"type":42},{"date":273,"type":42},"2020-06-01",{"date":275,"type":22},"2029-09-30",{"name":277,"class":49},"IRCCS San Raffaele",{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":4,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":286,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100587548","research-on-the-safety-and-efficacy-of-intraoperative-radiation-therapy-in-malignant-cerebral-tumor-100587548","NCT06929819","Research on the Safety and Efficacy of Intraoperative Radiation Therapy in Malignant Cerebral Tumor","Inclusion Criteria:\n\n* 18-75 years old, non-pregnant or lactating women\n* KPS ≥60\n* MRI and CT of the brain with contrast should be considered for diagnosis of high-grade glioma or other malignant brain tumors\n* No other underlying diseases that affect survival time, follow-up or quality of life, and no other serious organic lesions\n* Not receive radiotherapy, chemotherapy and other treatment methods for intracranial lesions in the past;\n* Tumor located supratentorium, and the position should ensure that the tumor resection volume is more than 90%;\n* The required dose of standard radiotherapy exceeds normal tissue tolerance\n* No related contraindications such as intraoperative radiotherapy and craniotomy.\n\nExclusion Criteria:\n\n* Refuse to undergo craniotomy or radiation therapy;\n* The postoperative paraffin pathological results were not high-grade gliomas or other cranial malignant tumors;\n* Refuse to participate in the clinical trial after informed consent without the above exclusion criteria.","75 Years",{"count":243,"type":22},[287],"NA","According to the latest national cancer statistics released by the National Cancer Center in February 2022, intracranial tumors account for about 60%-70% of the more than 3.5 million cancer patients, and the morbidity and mortality remain high. Intracranial malignant tumors have become a problem that needs to be solved urgently because of their early recurrence, rapid progression, and short survival, and intracranial malignant tumors include high-grade gliomas, metastases, lymphomas, etc.\n\nGlioblastoma (GB) is the most common primary malignancy in the adult central nervous system, accounting for about 57% of all gliomas and 48% of all primary weighted nervous system malignancies. At present, the standard treatment for glioblastoma is mainly surgical treatment, supplemented by postoperative concurrent chemoradiotherapy and adjuvant chemotherapy, but the prognosis of patients is still poor, with a one-year survival rate of 40.6%, a five-year survival rate of only 5.6%, and an average survival time of 12-15 months.\n\nFor patients diagnosed with intracranial malignancies (including high-grade glioma, metastases, lymphoma, etc.), multimodal image-guided microsurgery combined with postoperative chemoradiotherapy recommended by the guidelines, and intraoperative radiotherapy with tumor bed radiation therapy to achieve targeted and precise tumor treatment, thereby improving the prognosis of patients (including progression-free survival and median overall survival, etc.)",[30,34,86],[33,291],"Intraoperative Radiation Therapy","2025-04-15",{"date":294,"type":42},"2025-04-16",{"date":296,"type":22},"2025-06-01",{"date":298,"type":22},"2030-05-31",{"name":300,"class":49},"First Affiliated Hospital, Sun Yat-Sen University",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":50},"100537802","feelfit-high-intensity-interval-training-to-improve-self-reported-physical-fitness-in-brain-tumor-patients-100537802","NCT06282562","FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients","FeelFit: High-intensity Interval Training to Improve Self-reported Physical Fitness in Brain Tumor Patients: a Randomized Controlled Trial","FeelFit","Inclusion Criteria:\n\n* reduced self-reported physical fitness;\n* minimum age of 18 years;\n* diagnosed with a primary brain tumor;\n* stable disease, i.e. no signs of radiological or clinical tumor progression;\n* no oncological treatment for at least two months prior to inclusion;\n* able to speak, read and write in Dutch.\n\nExclusion Criteria:\n\n* Karnofsky Performance Score \\\u003C 70;\n* already participated in a HIIT program \\\u003C 1 month prior;\n* contraindication of exercise.",{"count":310,"type":22},36,[287],"The FeelFit study aims to assess the effectiveness of High-Intensity Interval Training (HIIT) in improving self-reported physical fitness in adult brain tumor patients during periods of stable disease, as compared to a waiting-list control group. Furthermore, several secondary and exploratory outcomes will be evaluated. The study is part of the GRIP (GuaRding quality survivorshiP) project, which aims to improve quality of life in brain tumor patients.",[34,314],"Exercise","2025-04-02",{"date":317,"type":42},"2025-04-06",{"date":319,"type":42},"2024-01-01",{"date":321,"type":22},"2026-08-15",{"name":323,"class":49},"Amsterdam UMC, location VUmc",{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":330,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":332,"targetDuration":334,"studyType":59,"phases":4,"briefSummary":335,"conditions":336,"keywords":341,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":50},"100458790","seoul-cohort-of-brain-tumor-monitoring-study-solomon-100458790","NCT05254197","SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)","The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study","SOLOMON","Inclusion Criteria for retrospective cohort\n\n* Patients with radiologically diagnosed brain neoplasm of CNS WHO grade 2 or less since 1998\n* Asymptomatic at first visit to the hospital\n* Patients who, based on the up-to-date knowledge, did not necessarily require immediate treatment at the first hospital visit\n* Patients who have had two or more MRs at least 3 months apart\n* No previous radiotherapy or radiosurgery for the brain lesion\n* 18 years old or more\n\nInclusion Criteria for prospective cohort\n\n* Patients with newly diagnosed brain neoplasm of CNS WHO grade 2 or less\n* Asymptomatic at first visit to the hospital\n* Patients who, based on the up-to-date knowledge, did not necessarily require immediate treatment at the first hospital visit and who are going to take follow-up MR exams\n* No previous radiotherapy or radiosurgery for the brain lesion\n* 18 years old or more\n* Patients who agree to participate by written consent\n\nExclusion Criteria\n\n* Patients who lost follow-up before the second MR exam\n* Patients requiring immediate treatment due to worsening of symptoms within 3 months of the first MR exam\n* Patients suspected to have other than a neoplasm at follow-up MR exams",{"count":333,"type":22},3000,"15 Years","The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had magnetic resonance (MR) re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. In all MRs taken by patients, the date of imaging and the volume of the tumor are measured, and we aim to establish a natural growth history for non-malignant brain tumors.",[34,337,338,339,340],"Meningioma","Schwannoma","Pituitary Adenoma","Gliomas Benign",[342,343,337,338,344,345],"Non-malignant brain tumor","Benign brain tumor","Pituitary adenoma","Benign glioma","2024-11-30",{"date":348,"type":42},"2024-12-03",{"date":350,"type":42},"2001-01-01",{"date":352,"type":22},"2035-12-31",{"name":354,"class":49},"Seoul National University Hospital"]