[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-neoplasms":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,60,96,128,150,171,203,226,253,297,339,362,390,414,445,483,530,559],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":39,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603",false,"NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","ALL","16 Years",{"count":19,"type":20},124,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[26,27,28,29,30,31,32,33,34,35,36,37,38],"Melanoma","Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[40,41,42,43,44,45,46],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600","RECRUITING","2026-06-29",{"date":50,"type":51},"2026-07-01","ACTUAL",{"date":53,"type":51},"2022-11-30",{"date":55,"type":20},"2029-06-18",{"name":57,"class":58},"Pfizer","INDUSTRY",83,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":95},"100641175","connectome-guided-navigation-for-eloquent-area-tumor-surgery-trial-100641175","NCT07657403","CONNEctome-guided Navigation for Eloquent-area Tumor Surgery Trial","A Prospective, Randomized, Controlled Superiority Trial of Connectome-Guided Navigation-Assisted Microsurgical Resection for Functional Preservation in Eloquent-Area Brain Tumors","CONNECT Trail","Inclusion Criteria:\n\n1. Patients clinically diagnosed with brain tumors involving language areas, motor areas, or major functional brain networks, including the default mode network, central executive network, dorsal attention network, or ventral attention network.\n2. Karnofsky Performance Status (KPS) score of 70 or higher.\n3. Preoperative MRI demonstrating a spatial relationship between the tumor and major white matter tracts, such as the corticospinal tract or arcuate fasciculus.\n4. No other neurological disease or underlying condition that may cause neurological dysfunction.\n5. No prior treatment for a brain tumor in the same region, such as radiotherapy.\n6. Tumor not extensively adherent to multiple critical network nodes.\n7. Planned craniotomy for tumor resection and provision of written informed consent by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Pathologically or clinically suspected non-neoplastic brain lesion.\n2. Multifocal tumors.\n3. Incomplete evaluation data.\n4. Withdrawal from the study by the patient or legally authorized representative for any reason.\n5. Pregnancy, lactation, possibility of pregnancy, or planned pregnancy.",{"count":69,"type":20},200,[71],"NA","This study is designed for patients with brain tumors located in eloquent brain areas involved in language, motor, or major functional brain networks. The purpose of the study is to determine whether connectome-guided navigation-assisted microsurgical resection can better preserve neurological function after surgery than conventional tractography-guided surgery.\n\nParticipants who meet the study criteria will be assigned to one of two surgical planning strategies. In the experimental group, patients will undergo preoperative diffusion tensor imaging and resting-state functional MRI for individualized brain network reconstruction, and these data will be integrated with intraoperative navigation and neurophysiological monitoring to guide the resection boundary. In the control group, surgery will be guided by conventional DTI tractography-assisted navigation.\n\nThe main outcome is the rate of postoperative functional preservation. Other outcomes include extent of tumor resection, postoperative complications, time to neurological recovery, overall survival, and quality of life. Patients will be evaluated before surgery and followed after surgery with clinical examinations, neurological assessments, and MRI at prespecified time points.",[31,74],"Eloquent Area Brain Tumors",[76,77,78,79,80,81,82,83,84],"Connectome-guided surgery","Eloquent area brain tumor","Brain network navigation","Diffusion tensor imaging","DTI tractography","Resting-state fMRI","Functional preservation","Microsurgical resection","Intraoperative neurophysiological monitoring","2026-06-14",{"date":87,"type":51},"2026-06-18",{"date":89,"type":51},"2025-11-01",{"date":91,"type":20},"2028-12-31",{"name":93,"class":94},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100468924","phase-1-study-of-abemaciclib-and-elacestrant-in-participants-with-brain-metastasis-due-to-erher-2--breast-cancer-100468924","NCT05386108","Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+\u002FHER-2- Breast Cancer","An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","ELECTRA","Inclusion Criteria:\n\n1. Participant has the signed informed consent form before any study-related activities according to local guidelines.\n2. Women or men aged ≥18 years, at the time of informed consent signature.\n\n   * Female participants may be either postmenopausal or pre\u002Fperimenopausal. Postmenopausal status is defined by:\n\n     1. Age ≥60 years\n     2. Age \\\u003C60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges\n     3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).\n   * Pre-menopausal \u002F peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.\n3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:\n\n   * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity\n   * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing\n4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.\n\n   * Any of the following qualifies brain metastases as active:\n\n     1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.\n     2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.\n     3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.\n   * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \\[mm\\] by computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]).\n   * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.\n5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.\n6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.\n7. Participants' prior therapy received in the metastatic setting includes:\n\n   * At least one endocrine therapy\n   * Up to two chemotherapy regimens\n   * Up to two lines of prior cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, not including abemaciclib\n\n   Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).\n\n   Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.\n8. Participant has documented intracranial and\u002For extracranial radiological progression or recurrence while on or after the most recent therapy.\n9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n10. Participant has a life expectancy ≥ 12 weeks.\n11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002Fliter (L)\n    2. Platelets ≥100 × 10\\^9\u002FL\n    3. Hemoglobin ≥9.0 grams (g)\u002Fdeciliter (dL)\n    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)\n    5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL\u002Fminute\n    6. Serum albumin ≥3.0 g\u002FdL (≥30 g\u002FL)\n    7. Liver function tests:\n\n       In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.\n    8. Total serum bilirubin \\\u003C1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.\n2. Participant has imminent organ failure and\u002For visceral crisis.\n3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.\n4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced\u002Fmetastatic setting.\n5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.\n6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.\n7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.\n8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.\n9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.\n10. Prior anti-cancer or investigational drug treatment within the following windows:\n\n    * Fulvestrant treatment (last injection) \\\u003C42 days before first dose of study drug\n    * Any other endocrine therapy \\\u003C14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.\n    * Chemotherapy or other anti-cancer therapy \\\u003C14 days before first dose of study drug\n    * Any investigational anti-cancer drug therapy within \\\u003C28 days or \\\u003C5 half lives, whichever is shorter\n    * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \\\u003C1 month prior to first dose of study drug according to institutional guidelines.\n11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.\n12. Uncontrolled significant active infections\n\n    * Participants with hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening\n    * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.\n13. Major surgery within 4 weeks of starting trial therapy.\n14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.\n15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:\n\n    1. Intrauterine device (non-hormonal)\n    2. Sexual abstinence\n    3. Bilateral tubal occlusion\u002Fligation\n    4. Have a vasectomized partner with confirmed azoospermia.\n16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.\n17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.\n18. Known intolerance to either study drug or any of their excipients.\n19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:\n\n    1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \\\u003C5 half-lives, whichever is shorter)\n    2. Herbal preparations\u002Fmedications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy\n    3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.\n20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.","18 Years",{"count":106,"type":20},73,[23,108],"PHASE2","This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.",[111,31,112,113,114,115,116,117],"Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","Central Nervous System Neoplasms","Brain Diseases","Central Nervous System Diseases","2026-06-03",{"date":120,"type":51},"2026-06-04",{"date":122,"type":51},"2022-08-31",{"date":124,"type":20},"2026-12",{"name":126,"class":58},"Stemline Therapeutics, Inc.",86,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":95},"100528813","guided-meditation-during-radiation-therapy-for-brain-tumors-100528813","NCT06165653","Guided Meditation During Radiation Therapy for Brain Tumors","An Interventional Trial Using Guided Meditation During Radiation Therapy for Brain Tumors","Med-RT","Inclusion Criteria:\n\n* Participant aged ≥ 18 years.\n* Radiologically confirmed tumor of the brain. Note: Participants may have tumor resected after diagnosis.\n* Eligible to undergo radiation treatment for brain tumor for 25-33 treatments.\n* Willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment.\n* Karnofsky performance score ≥ 60 or ECOG performance score ≤ 2.\n* MoCA mini score ≥ 11\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* Active suicidal ideation or active psychotic state in the opinion of the investigator.\n* An unstable illness that, in the opinion of the investigator, would interfere with study treatment.\n* Prior radiation therapy to the brain.\n* Inability to understand and\u002For speak the English language.",{"count":137,"type":20},30,[71],"The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors.\n\nThe main question it aims to answer is:\n\n• What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions?\n\nParticipants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.",[31],"2026-03-17",{"date":143,"type":51},"2026-03-20",{"date":145,"type":51},"2024-02-29",{"date":147,"type":20},"2028-01-15",{"name":149,"class":94},"University of Utah",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":95},"100540881","ommaya-reservoir-placement-at-the-time-of-biopsy-for-longitudinal-biomarker-collection-in-patients-with-brain-tumors-100540881","NCT06322602","Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors","Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection","Inclusion Criteria:\n\n* Clinical and radiographic evidence suggesting a diagnosis of a brain tumor\n* Planned biopsy for suspected or previously diagnosed brain tumor as part of routine clinical care at Mayo Clinic (Rochester, Minnesota \\[MN\\])\n* Willingness of the patient to provide informed consent\n* Patient is willing to have their Ommaya sampled on at least 2 future occasions\n* Patients is willing to have CSF banked through the neuro-oncology biorepository (requires a separate signature)\n\nExclusion Criteria:\n\n* Adults lacking capacity to consent\n* Vulnerable populations including pregnant women, prisoners, and individuals \\\u003C 18 years old\n* Patients who are not appropriate candidates for biopsy due to current or past medical history or uncontrolled current illness\n* Prior history of any wound infection\n* Any patient who the surgeon feels is not an optimal candidate for Ommaya reservoir placement. Such reasons may include, but will not be limited to, surgical anatomy, clinical evidence of immunosuppression, and\u002For elevated risk of wound infection due to diabetes, smoking history, morbid obesity, or any other concerns",{"count":158,"type":20},20,[71],"This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.",[31],"2026-02-27",{"date":164,"type":51},"2026-03-03",{"date":166,"type":51},"2024-02-28",{"date":168,"type":20},"2029-03",{"name":170,"class":94},"Mayo Clinic",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":201,"locationsCount":95},"100625762","ot-smile-occupational-therapy-group-intervention-for-primary-brain-tumour-patients-100625762","NCT07426848","OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients","Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours","OTSMILE","Inclusion Criteria:\n\nAge ≥ 18 years Diagnosis of primary brain tumour Currently receiving systemic anti-cancer treatment (SACT) Experiencing difficulty with occupational performance (self-reported or clinician-identified) Sufficient cognitive and communication ability to participate in group sessions (assessed clinically and\u002For via screening tool) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Able to provide written informed consent\n\nExclusion Criteria:\n\nECOG performance status ≥ 3 Current inpatient status Major depressive episode or significant psychiatric condition preventing participation in group sessions Significant language barrier preventing participation in English-language sessions\n\nInability to provide informed consent\n\n\\-",{"count":180,"type":20},96,[71],"People diagnosed with primary brain tumours often experience significant symptoms such as fatigue, cognitive changes, anxiety, and reduced ability to carry out everyday activities. These symptoms may be related to the tumour itself or to ongoing systemic anti-cancer treatment. In Ireland, access to structured rehabilitation and symptom management programmes for this population is limited.\n\nThe OT SMILE study is evaluating whether a structured occupational therapy-led group programme can improve quality of life and daily functioning in adults with primary brain tumours receiving active treatment.\n\nParticipants attending Beaumont Hospital who meet eligibility criteria and provide informed consent will be randomly assigned (like flipping a coin) to one of two groups:\n\nA six-week occupational therapy group programme (OT SMILE), or\n\nUsual care, consisting of written lifestyle management information.\n\nThe OT SMILE programme consists of six weekly 90-minute group sessions delivered by occupational therapists. Sessions focus on fatigue management, activity modification, cognitive strategies, relaxation techniques, goal setting, exercise, nutrition, and peer support.\n\nParticipants in both groups will complete questionnaires before the programme begins and again after six weeks. These questionnaires measure quality of life, fatigue, and daily functioning.\n\nThe main goal of the study is to determine whether the occupational therapy group programme improves health-related quality of life compared to usual care. The results may help inform supportive care services for people living with primary brain tumours.",[184,185,31],"Primary Brain Tumour","Glioblastoma",[187,188,189,190,191,192,193,194],"Occupational Therapy","Symptom Management","Brain Cancer","Neuro-Oncology","Supportive Care","Rehabilitation","Health Related Quality of Life","FACT-BR","2026-02-16",{"date":197,"type":51},"2026-02-23",{"date":199,"type":51},"2025-12-18",{"date":91,"type":20},{"name":202,"class":94},"Royal College of Surgeons, Ireland",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":209,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":95},"100613901","detection-of-brain-metastases-using-a-novel-gadolinium-weighted-mri-sequence-a-prospective-comparison-100613901","NCT07272616","Detection of Brain Metastases Using a Novel Gadolinium-Weighted MRI Sequence: A Prospective Comparison","A Prospective Comparative Study of a Novel Gadolinium-Weighted MRI Sequence Versus Conventional T1-Weighted Imaging for the Detection of Brain Metastases","GDW","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for clinical brain MRI with gadolinium contrast\n* Known or suspected brain metastases\n* Able to provide informed consent\n* Able to lie still for the duration of the MRI examination\n\nExclusion Criteria:\n\n* Contraindications to MRI\n* Known allergy or contraindication to gadolinium-based contrast agents\n* Renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²)\n* Pregnant or breastfeeding\n* Inability to comply with study procedures",{"count":212,"type":20},100,"OBSERVATIONAL","This study will evaluate a new type of MRI sequence designed to improve the visibility of brain metastases after gadolinium contrast injection. The purpose is to determine whether this novel \"gadolinium-weighted\" imaging method can detect more or smaller tumors than standard MRI techniques. Participants will undergo a routine brain MRI with contrast, followed by an additional scan using the new method. The goal is to improve diagnostic accuracy without increasing the contrast dose or scan time.",[31],"2026-01-29",{"date":218,"type":51},"2026-01-30",{"date":220,"type":51},"2026-01-28",{"date":222,"type":20},"2027-12-31",{"name":224,"class":225},"Region Stockholm","OTHER_GOV",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":21,"phases":236,"briefSummary":237,"conditions":238,"keywords":241,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":95},"100443035","platelets-activation-in-brain-neoplasms-100443035","NCT05049148","Platelets Activation in Brain Neoplasms","Observation of Platelets in Primary and Secondary Tumors of the Central Nervous System and Association With Survival: a Prospective Cohort Study","Platon","Inclusion Criteria:\n\n* Patient to undergo excision or biopsy of a brain or medullary tumor\n* Patient over 18 years old\n* Express consent to participate in the study\n* Affiliate member of the Social Security system\n\nExclusion Criteria:\n\n* Tumor sample volume not allowing the performance of additional analyzes\n* Patient benefiting from a legal protection measure\n* Pregnant or breastfeeding woman",{"count":235,"type":20},50,[71],"Platelets are primarily known for their central role in primary hemostasis. However, they are increasingly recognized for their participation in various non-hemostatic processes, such as cancer progression and clinical expression. Experimental and clinical data indicate that the involvement of platelets in the pathophysiology of cancer goes far beyond the realm of cancer-associated thrombosis.\n\nSeveral experimental studies have shown that platelets can promote the metastatic process by various mechanisms. However, while it has been shown in vitro that direct contact with platelets initiates tumor cells for metastasis, it remains unclear whether such contacts occur in solid tumors. In addition to their ability to promote metastasis, platelets have been shown to stimulate angiogenesis and play a crucial role in lymphangiogenesis.\n\nConsidering that blood vessels, lymphatics and immune cells are major components of the tumor ecosystem, our hypothesis is that platelets contribute to the development and \u002F or regulation of the tumor microenvironment. This is because platelets stabilize tumor blood vessels by permanently repairing vascular damage caused by immune cells infiltrating tumors. Targeting platelets destabilizes tumor vessels, causing intra-tumor hemorrhage, which allows intra-tumor accumulation of intravenously administered anti-tumor drugs such as paclitaxel and improves their efficacy.\n\nStudies have also reported the role of platelets in several pathogenic mechanisms of cancer: thrombocytosis is a paraneoplastic syndrome which suggests a poor prognosis in patients with solid tumors; a negative correlation between the platelet count and the response to chemotherapy has been reported in several types of cancer; histological analyzes of esophageal cancer suggested a possible association between the presence of platelets in the tumor stroma and the level of tumor lymphangiogenesis and lymphovascular invasion; finally, a recent study reported the expression of one of the main targets of immunotherapies, PD-L1, on the platelets of patients suffering from different types of solid cancers.\n\nAll of these data support our hypothesis that platelets are components and \u002F or regulators of the tumor microenvironment and therefore potential targets for the improvement of anti-tumor therapies. In this context, the objectives of our project are to determine whether platelets are components of the microenvironment of tumors of the central nervous system, and to study the possible correlations between the intratumoral presence of platelets and the evolution of patients with central nervous system tumors",[27,239,240,31],"Blood Platelets","Inflammation",[242],"Platelets activation","2025-12-30",{"date":245,"type":51},"2026-01-05",{"date":247,"type":51},"2022-10-27",{"date":249,"type":20},"2029-10",{"name":251,"class":252},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":264,"conditions":265,"keywords":273,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":294,"locationsCount":296},"100498460","phase-2-determine-trial-treatment-arm-03-entrectinib-in-adult-paediatric-and-teenageyoung-adult-patients-with-ros1-gene-fusion-positive-cancers-100498460","NCT05770544","DETERMINE Trial Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 03: Entrectinib in Adult, Paediatric and Teenage\u002FYoung Adult Patients With ROS1 Gene Fusion-Positive Cancers.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 03 (ENTRECTINIB) OUTLINED BELOW\\*\n\n\\*When entrectinib-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the entrectinib-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a ROS1 gene fusion-positive malignancy, other than NSCLC, that has been identified using an analytically validated next-generation sequencing method.\n\nB. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nC. Patients with a BSA of 0.43m\\^2 and over.\n\nD. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nE. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nF. Women of childbearing potential are eligible provided that they meet the following criteria:\n\n* Have a negative serum or urine pregnancy test before enrolment and either:\n* Agree to use one form of highly effective birth control method such as:\n\nI. Oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n\nII. Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation\n\nIII. Intrauterine device (IUD)\n\nIV. Intrauterine hormone-releasing system (IUS)\n\nV. Bilateral tubal occlusion\n\nVI. Vasectomised partner\n\nPlus a barrier method if using a hormonal method: male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide OR\n\n• Sexual abstinence;\n\nEffective from the first administration of entrectinib, throughout the trial and for five weeks after the last administration of entrectinib.\n\nG. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of entrectinib, throughout the trial and for three months after the last administration of entrectinib:\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses a highly effective method of contraception as in F above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nExclusion Criteria:\n\nA. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within five weeks following their last dose of entrectinib\n\nB. Diagnosis of ROS1 fusion-positive NSCLC\n\nC. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to entrectinib\n\nD. Patients with significant cardiovascular disease are excluded as defined by:\n\ni. Current congestive heart failure requiring therapy (New York Heart Association III or IV) or known left ventricular ejection fraction (LVEF) \\\u003C50% (moderate to severe).\n\nii. History of unstable angina pectoris or myocardial infarction up to three months prior to trial entry, or current poorly controlled angina (symptoms weekly or more).\n\niii. Presence of symptomatic or severe valvular heart disease (severe by local echo graphic criteria or American Heart Association\u002FAmerican Cardiac College Stage C or D).\n\niv. History of a clinically significant cardiac arrhythmia up to three months prior to trial entry (asymptomatic atrial fibrillation or asymptomatic first-degree heart block are permitted.\n\nv. History of stroke (ischaemic or haemorrhagic) within the last three months.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of entrectinib, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nE. Patients with a baseline QTcF (Corrected QT interval by Fridericia formula) interval longer than 450 milliseconds (ms) for male patients and 470 ms for female patients, patients with congenital long QTcF syndrome, and patients taking medicinal products that are known to prolong the QTc interval.\n\nF. History of additional risk factors for Torsades de Pointes (e.g., family history of long QT syndrome)\n\nG. Grade ≥2 peripheral neuropathy\n\nH. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of entrectinib, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.\n\nI. Known hypersensitivity to entrectinib or any of the excipients\n\nJ. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during entrectinib treatment or within six months after the final dose of entrectinib\n\nK. Patient unable to swallow entrectinib intact, without chewing, crushing or opening the capsules (as per the dosing schedule and suitable dosing strengths available). Any active gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably affect drug absorption\n\nL. Patients with personal history of significant osteopenia (screening for osteopenia not required)\n\nM. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial",{"count":137,"type":20},[108,263],"PHASE3","This clinical trial is looking at a drug called entrectinib. Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years old or above with solid tumours which have another type of change in the cancer cells. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive). If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[266,267,268,269,270,112,271,31,26,27,272],"Haematological Malignancy","Malignancy","Malignant Neoplasm","Lymphoproliferative Disorders","Neoplasms by Histologic Type","Cancer","Solid Tumour",[274,275,271,276,277,267,30,278,279,280,112,281,282,283,284,285,286,287],"Adult","Antineoplastic Agents","Child","Entrectinib","Molecular Targeted Therapy","Mutation","Neoplasms by Histologic Site","Oncogene","Paediatric","Protein Kinase Inhibitors","Rare","ROS1 Protein, human","Tumour-agnostic","Young adult","2025-11-19",{"date":290,"type":51},"2025-11-24",{"date":292,"type":20},"2025-11-30",{"date":249,"type":20},{"name":295,"class":94},"Cancer Research UK",27,{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":21,"phases":306,"briefSummary":307,"conditions":308,"keywords":319,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":95},"100587627","hobscotch-ca-home-based-self-management-and-cognitive-training-changes-lives-in-brain-cancer-100587627","NCT06930846","HOBSCOTCH-CA (HOme-Based Self-management and COgnitive Training CHanges Lives in Brain CAncer)","HOBSCOTCH-CA","CA Participants will be referred to the study by their providers (Oncologist) who will be made aware of the study and inclusion\u002Fexclusion criteria. Inclusion Criteria 2. - 5. and Exclusion Criteria 1. - 3. will be confirmed by referring providers. Participants who learn about the study here and elsewhere will be instructed on how to confirm their eligibility with their provider.\n\nInclusion Criteria for CA Participant:\n\n1. 18 + years\n2. Service members, Veterans and civilians with a diagnosis of brain cancer (excluding glioblastoma)\n3. Diagnosis of primary brain tumor with expected survival of 2 years or greater (e.g., low-grade glioma, oligodendroglioma, IDH mutant astrocytoma, meningioma) defined as the presence of a primary lesion on neuroimaging (CT or MRI), confirmed by histopathological examination (Note: some patients being treated for meningioma may be treated with radiotherapy without need for initial histopathologic confirmation)\n4. Patients undergoing surgical and\u002For radiation therapy will have completed their treatment at least 3 months prior to being enrolled in trial (Note: patients receiving chemotherapy or other systemic therapy will be included)\n5. Stable on all CNS acting medications for one month prior to enrollment\n6. Subjective cognitive complaints\n7. Literate and proficient in English\n8. Internet access for the pre-session and Session 1 of the HOBSCOTCH-CA program; telephone access for sessions 2-8\n\nExclusion Criteria for CA Participant:\n\n1. Presence of a neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease)\n2. Acute psychiatric disorder or substance abuse\n3. Patients with glioblastoma (GBM)\n\nInclusion Criteria for CA Participant Caregiver:\n\n1. Age 18 +\n2. Caregiver to a patient with a confirmed diagnosis of brain cancer\u002Ftumor survivor\n3. CA Subject has given permission for their caregiver to participate\n4. Literate and proficient in English\n5. Internet access (for Pre-HOBSCOTCH and Session 1)\n6. Telephone access (for Session 8)\n\nExclusion Criteria for CA Participant Caregiver:\n\n1. Significant visual impairment precluding reading or writing\n2. No reliable telephone or internet access",{"count":305,"type":20},125,[71],"The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-CA, to improve the quality of life and cognitive function in Service Members, Veterans and civilians who are survivors of brain cancer or a brain tumor (CA participants). This study will also assess the ability of the HOBSCOTCH-CA program to improve quality of life in caregivers of patients with brain cancer\u002Ftumor and to reduce caregiver burden. Enrolling with a Caregiver is optional for CA participants.\n\nInvestigators will compare two groups of CA participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOCTCH-CA immediately (Group 1) and another group that will receive HOBSCOTCH-CA (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.\n\nHOBSCOTCH-CA involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a \"pre\" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. CA participants are asked to do short homework assignments and keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).",[189,309,31,310,311,312,313,314,315,316,317,318],"Brain Tumor","Primary Brain Tumor","Low-grade Glioma","Oligodendroglioma","Meningioma","Low Grade Astrocytoma","Cognitive Dysfunction","Memory Impairment","Memory Disorders","Memory Dysfunction",[320,321,322,323,324,325,326,327,328,329],"Brain cancer survivor","Brain tumor survivor","Cognition","Self-management","Cognitive training","Memory disorders","Cognitive remediation","Caregiver","Caregiver burden","Mindfulness","2025-11-18",{"date":332,"type":51},"2025-11-21",{"date":334,"type":51},"2025-11-03",{"date":336,"type":20},"2028-12",{"name":338,"class":94},"Dartmouth-Hitchcock Medical Center",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":347,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":95},"100601491","intraoperative-fluorescence-guided-aspirate-tissue-monitoring-of-5-ala-during-brain-tumor-surgery-100601491","NCT07111182","Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery","ATM 5-ALA: Intraoperative Fluorescence-Guided Aspirate Tissue Monitoring of 5-ALA During Brain Tumor Surgery","ATM5-ALA","Inclusion Criteria:-\n\n* Patient admitted to neurosurgery department for surgical resection of a suspected grade 3 or 4 glioma with 5-ALA (cases)\n* Patient admitted to neurosurgery department for surgical resection of a primary of secondary brain tumor with no 5-ALA (controls)\n* Patients aged 18 years old or older (all patients)\n* Informed consent obtained (all patients)\n\nExclusion Criteria:\n\n* Patient belongs to the following vulnerable groups: children, pregnant, prisoners or intellectually disabled.\n* The participants are not randomized. Randomization is not conducted as the number of eligible patients is limited, subjecting to a long recruitment period that reciprocally increases the bias from uncontrollable (evolving) surgical techniques and adjunct treatments.\n* The patients are screened and informed of the study before the surgical operation and enrolled after verification of eligibility and written informed consent has been received.\n\nPotential study participants are identified from the clinic's planned or urgent surgeries list. The participants are contacted before the operation by the research staff and\u002For the physician responsible for the treatment. The participants are provided with written and oral information about the research and the time to consider their participation. Finally, the participants are asked for their informed consent and enrolled to the study.","99 Years",{"count":349,"type":20},8,[71],"Gliomas are tumors that occur in all ages; they include the most common malign primary central nervous system tumors in developed countries. Gliomas are often aggressive, and their recommended treatment is surgical resection and chemoradiation. Complete tumor removal is challenging because of diffuse cell growth and the proximity of functionally critical tissues. The current golden standard for intraoperative glioma detection is fluorescence-guided surgery (FGS) using 5-ALA. In 5-ALA FGS the drug-induced fluorescence helps to visually detect tumor cells, which improves resection rates and delays tumor progression. Tumor cells are often left unnoticed because of visual obstacles or weak fluorescence, which may lead to local recurrence and reoperations. Surgical suction devices are routinely used to remove cancerous tissues, but so far, the analysis of the suction waste has not been used in near real-time tissue detection.",[31],"2025-11-07",{"date":355,"type":51},"2025-11-12",{"date":357,"type":51},"2025-10-27",{"date":359,"type":20},"2027-12-30",{"name":361,"class":94},"University of Illinois at Chicago",{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":21,"phases":372,"briefSummary":373,"conditions":374,"keywords":377,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":388,"locationsCount":95},"100525931","phase-1-phase-i-study-of-jyp0322-in-ros1-fusion-positive-solid-tumors-100525931","NCT06128148","Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of JYP0322 in Patients With Solid Tumors","JYP0322","Key Inclusion Criteria\n\n* Adult patients age 18 years or older.\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumors that have a ROS1 molecular fusion.\n* Measurable disease according to RECIST version 1.1\n* Life expectancy of at least 3 months\n* Other protocol specified criteria\n\nKey Exclusion Criteria:\n\n* Current participation in another therapeutic clinical trial.\n* Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n* A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.\n* Known active infections (bacterial, viral including HIV positivity).\n* Other protocol specified criteria",{"count":371,"type":20},101,[23],"An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced\u002Fmetastatic solid tumors .",[283,375,376,31],"Other Protocol Specified Criteria","Lung Neoplasms",[378,379,380,381],"ROS1 Fusions","ROS1 Gene Rearrangements","Primary brain tumors","ROS1","2025-07-09",{"date":384,"type":51},"2025-07-14",{"date":386,"type":51},"2022-05-04",{"date":359,"type":20},{"name":389,"class":58},"Guangzhou JOYO Pharma Co., Ltd",{"id":391,"slug":392,"hasResults":11,"nctId":393,"briefTitle":394,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":398,"conditions":399,"keywords":400,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":411,"locationsCount":413},"100371071","diagnostic-assessment-of-amino-acid-petmri-in-the-evaluation-of-glioma-and-brain-metastases-100371071","NCT04111588","Diagnostic Assessment of Amino Acid PET\u002FMRI in the Evaluation of Glioma and Brain Metastases","Inclusion Criteria:\n\n* Inclusion criteria Glioma (LGG, HGG and recurrent HGG):\n\n  * Planned treatment for WHO grade II-IV diffuse glioma\n  * Adult patients (\\>18 years)\n  * Planned tissue sampling for histopathological diagnosis.\n  * KPS \\>60 (able to care for self)\n\nInclusion criteria Brain Metastasis:\n\n* Indication of surgery or stereotactic radiosurgery for 1-4 brain metastases\n* Planned surgery: Suspicion of brain metastasis or known diagnosis\n* Stereotactic surgery: Known primary cancer\n* Adult patients (\\>18 years)\n* Estimated survival at least 3 months after inclusion\n\nExclusion Criteria:\n\n* Exclusion criteria (Glioma and Brain Metastasis):\n\n  * Pacemakers or defibrillators not compatible with 3T MRI\n  * No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).\n  * Pregnancy (pregnancy test for all women in fertile age when doubt about possible pregnancy exist)\n  * Breastfeeding\n  * Weight \\> 120 kg",{"count":397,"type":20},160,"MRI is used in clinical routine for diagnosing brain tumors, but has limitations in identifying tumor grade, true tumor extension and differentiate viable tumor tissue from treatment induced changes and recurrences.\n\nAmino acid PET has demonstrated a great potential for defining true tumor volume, differentiate viable tumor tissue from postoperative changes or radiation necrosis, selection of biopsy site, non-invasive grading of gliomas and for treatment planning and therapy response assessment. By combining PET with MRI, the diagnostic accuracy can improve significantly for these patients. More research is however needed to compare the most promising amino acid PET tracers in patients with glioma, but also to assess the diagnostic value of amino acid PET in patients with different brain metastases, where the knowledge concerning the uptake characteristics is limited.\n\nThree of the most promising amino acid tracers (\\[11C\\]-methyl-methionine (11C-MET), \\[18F\\] fluoro-ethyl-tyrosin (18F-FET) and anti-1-amino-3-\\[18F\\]fluorocyclobutane-1-carboxylic acid (18F-FACBC)) will be evaluated in 3 substudies in this project; WP1 Aminoacid PET\u002FMRI in low and high grade glioma; WP2 Role of 11C-MET in high-grade glioma Gamma Knife® radiosurgery; and WP3 Amino acid PET in brain metastasis.\n\nThe main aim of the study is to improve diagnostic accuracy, histopathological tissue sampling, delineation of tumor extent and therapy response assessment in gliomas and brain metastases with amino acid PET\u002FMRI.",[31],[401,402,403,404],"Diagnosis","Magnetic Resonance Imaging","Positron-Emission Tomography","PET-tracer","2025-06-17",{"date":407,"type":51},"2025-06-22",{"date":409,"type":51},"2019-11-25",{"date":222,"type":20},{"name":412,"class":94},"Norwegian University of Science and Technology",3,{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":424,"briefSummary":425,"conditions":426,"keywords":430,"overallStatus":436,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":95},"100498934","clinical-trial-for-the-validation-of-ar-based-neuronavigation-system-100498934","NCT05776706","Clinical Trial for the Validation of AR Based Neuronavigation System","Clinical Trial for the Evaluation of the Accuracy of Augmented Reality Based Neuronavigation System","Inclusion Criteria:\n\n* Adult patients aged 18 years or older who underwent MRI or CT scan due to brain tumor or cerebrovascular disease\n* Adult patients aged 18 years or older who need surgical treatment using navigation for brain tumor or cerebrovascular disease\n\nExclusion Criteria:\n\n* Cases where application of navigation is not necessary according to the judgment of the researcher or surgeon\n* When the patient or guardian does not agree\n* Patients with anatomical deformation due to previous surgery or requiring emergency surgery","85 Years",{"count":423,"type":20},80,[71],"The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:\n\n• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.\n\nParticipants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.",[31,427,428,429],"Cerebral Aneurysm","Cerebral Arteriovenous Malformation","Navigation, Spatial",[431,432,433,434,435],"augmented reality","neuronavigation","brain neoplasms","cerebral arteriovenous malformation","cerebral aneurysm","NOT_YET_RECRUITING","2024-11-30",{"date":439,"type":51},"2024-12-03",{"date":441,"type":20},"2025-05-01",{"date":222,"type":20},{"name":444,"class":94},"Seoul National University Hospital",{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":16,"minAge":453,"maxAge":454,"enrollmentInfo":455,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":457,"conditions":458,"keywords":470,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":481,"locationsCount":95},"100516173","prognosis-prediction-system-of-patients-with-cardiovascular-and-cerebrovascular-diseases-based-on-multi-omics-100516173","NCT06001073","Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics","Prognosis Prediction System of Patients With Cardiovascular and Cerebrovascular Diseases Based on Multi-omics (PROSPECT): a National, Multicenter, Retrospective-prospective, Cohort Study","PROSPECT","Inclusion Criteria:\n\n* Patients who are regularly visited and followed up in the appropriate patient; department.\n* All patients met at least one of the following diagnostic criteria for cardiovascular and cerebrovascular diseases:\n* coronary artery disease group;\n* arrhythmia group;\n* heart valve disease group;\n* aortic dissection group;\n* cardiac masses group;\n* myocarditis group;\n* hypertension group;\n* cardiomyopathy group;\n* structural heart disease group;\n* ischemic cerebrovascular disease group;\n* hemorrhagic cerebrovascular disease group;\n* intracranial space occupying lesion group.\n\nExclusion Criteria:\n\n* Age \\\u003C3 years or \\>80 years old;\n* Pregnant and lactating women;\n* The patient declined to provide informed consent to participate in the study;\n* None of the above was met, but the patient was temporarily unable to sign the informed consent form due to coma and other reasons, and no legal representative signed it instead. Depending on the patient's condition, the patient may not be able to regain consciousness and sign the informed consent form.","3 Years","80 Years",{"count":456,"type":20},25000,"The etiology and specific pathogenesis of many cardiovascular diseases such as coronary atherosclerosis, cardiomyopathy, atrial fibrillation, and stroke are still unclear. Improving diagnosis and treatment, clarifying the pathogenesis, and providing scientific basis for the prevention and treatment are hot research topics in the study of cardiovascular and cerebrovascular diseases. This study intends to collect clinical data and biological specimen data of patients with cardiovascular and cerebrovascular diseases who meet the inclusion and exclusion criteria, and use multi-omics technology to deeply understand the pathogenic mechanisms of cardiovascular and cerebrovascular diseases and provide new ideas for specific and individualized treatment of patients with cardiovascular and cerebrovascular diseases, to construct early predictive prognostic models and provide a basis for effective treatment of clinical practice in patients with cardiovascular and cerebrovascular diseases.",[459,460,461,462,463,464,465,466,467,468,469,31],"Coronary Artery Disease","Arrhythmias, Cardiac","Heart Valve Diseases","Aortic Dissection","Heart Neoplasms","Myocarditis","Hypertension","Cardiomyopathies","Structural Heart Disease","Ischemic Cerebrovascular Disease","Hemorrhagic Cerebrovascular Disease",[471,472,473,474],"Cardiovascular diseases","Cerebrovascular diseases","Prognosis","Multi-omics","2024-07-10",{"date":477,"type":51},"2024-07-12",{"date":479,"type":51},"2022-12-05",{"date":91,"type":20},{"name":482,"class":94},"First Affiliated Hospital Xi'an Jiaotong University",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":491,"enrollmentInfo":492,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":494,"conditions":495,"keywords":503,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":349},"100537080","the-recmap-study-resection-with-or-without-intraoperative-mapping-for-recurrent-glioblastoma-100537080","NCT06273176","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)","RECMAP","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)19\n4. The tumor is suitable for resection (according to neurosurgeon)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Multifocal contrast-enhancing lesions\n3. Medical reasons precluding MRI (e.g., pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Clinical data unavailable for the newly diagnosed setting","90 Years",{"count":493,"type":20},225,"Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.\n\nThis study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[496,185,497,498,31,499,500,501,502],"Glioblastoma, IDH-wildtype","Glioblastoma Multiforme of Brain","Astrocytoma, Malignant","Brain Neoplasms, Adult, Malignant","Brain Neoplasms, Adult","Recurrent Adult Brain Tumor","Recurrent Glioblastoma",[185,504,505,506,507,508,509,510,511,512,513,514,515,516,517,518,519,520],"Recurrent","Re-resection","Resection","Intraoperative mapping","Awake mapping","Awake craniotomy","Asleep mapping","Motor mapping","Language mapping","Overall survival","Progression-free survival","Neurological morbidity","Quality of life","Functional area","Eloquent","Extent of resection","Residual tumor volume","2024-02-20",{"date":523,"type":51},"2024-02-22",{"date":525,"type":51},"2023-01-01",{"date":527,"type":20},"2028-01-01",{"name":529,"class":94},"Erasmus Medical Center",{"id":531,"slug":532,"hasResults":11,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":536,"eligibilityCriteria":537,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":491,"enrollmentInfo":538,"targetDuration":4,"studyType":213,"phases":4,"briefSummary":540,"conditions":541,"keywords":549,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":557,"locationsCount":349},"100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206","NCT06118723","The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","SUPRAMAX","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Multifocal contrast enhancing lesions\n3. Medical reasons precluding MRI (e.g. pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin",{"count":539,"type":20},784,"A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[185,542,496,543,544,545,546,498,31,547,500,548],"High-grade Glioma","Glioblastoma, IDH-mutant","Glioblastoma Multiforme, Adult","Astrocytoma, Grade IV","Astrocytoma, Grade III","Brain Neoplasm, Primary","Brain Neoplasm, Malignant",[185,550,551,552,515,516,513,514],"Supramaximal resection","FLAIRectomy","Non-contrast enhancement",{"date":523,"type":51},{"date":555,"type":51},"2022-01-01",{"date":527,"type":20},{"name":558,"class":94},"Jasper Gerritsen",{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":491,"enrollmentInfo":567,"targetDuration":4,"studyType":21,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":585},"100351856","the-safe-trial-awake-craniotomy-versus-surgery-under-general-anesthesia-for-glioblastoma-patients-100351856","NCT03861299","The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.","The SAFE-Trial: Safe Surgery for Glioblastoma Multiforme: Awake Craniotomy Versus Surgery Under General Anesthesia. A Multicenter Prospective Randomised Controlled Study","SAFE","Inclusion Criteria:\n\n1. Age ≥18 years and ≤ 90 years\n2. Tumor diagnosed as Glioblastoma Multiforme on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumour necrosis as assessed by the surgeon\n3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya Grading II and II)\n4. The tumor is suitable for resection (according to neurosurgeon)\n5. Karnofsky performance scale 80 or more\n6. Written Informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brain stem or midline\n2. Multifocal contrast enhancing lesions\n3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation\n4. Medical reasons precluding MRI (eg, pacemaker)\n5. Inability to give consent because of or language barrier\n6. Psychiatric history\n7. Previous brain tumour surgery\n8. Previous low-grade glioma.\n9. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.\n10. Severe aphasia or dysphasia",{"count":568,"type":20},246,[71],"The trial is designed as a multicenter randomized controlled study. 246 patients with presumed Glioblastoma Multiforme in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according the eligibility criteria (see under). After written informed consent is obtained, the patient will be randomized for an awake craniotomy (AC) (+\u002F-123 patients) or craniotomy under general anesthesia (GA) (+\u002F-123 patients), with 1:1 allocation ratio. Under GA the amount of resection of the tumour has to be performed within safe margins as judged by the surgeon during surgery. The second group will be operated with an awake craniotomy procedure where the resection boundaries for motor or language functions will be identified by direct cortical and subcortical stimulation. After surgery, the diagnosis of GBM will have to be histologically confirmed. If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study. These patients will be followed-up according to standard practice. Thereafter, patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up. Total duration of the study is 5 years. Patient inclusion is expected to take 4 years. Follow-up is 1 year after surgery. Statistical analysis, cost benefit analysis and article writing will take 3 months.",[185,572,497,545,309,189,31],"Glioblastoma Multiforme",[185,515,574,519,575,576,514,513],"Postoperative complications","Gross-total resection","Health-related quality of life","2023-11-18",{"date":579,"type":51},"2023-11-21",{"date":581,"type":51},"2019-04-01",{"date":583,"type":20},"2027-09-01",{"name":558,"class":94},5]