[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brain-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brain-cancer":43},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,39,0,25,[9,64,77,105,134,173,212,238,267,294,318,338,362,385,417,444,475,495,528,553,576,629,655,685,725],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":44,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100053479","phase-1-novel-indenoisoquinolone-cmyctopoisomerase-1-inhibitor-lmp744-in-recurrent-glioblastoma-100053479",false,"NCT07416188","Novel Indenoisoquinolone CMYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","Phase 1\u002FPhase 2 Open Label Trial of a Novel Indenoisoquinolone C-MYC\u002FTOPOISOMERASE 1 Inhibitor (LMP744) in Recurrent Glioblastoma","* INCLUSION CRITERIA:\n\nParticipant must meet all the following inclusion criteria to be deemed eligible for this study:\n\n* Participants \\>= 18 years of age\n* Tissue-based diagnosis of recurrent glioblastoma, IDH-wildtype by a neuropathologist\n* Karnofsky Performance Status (KPS) \\>60\n* Willing to use effective birth control method\n\n  --The effects of LMP744 on developing human fetuses are unknown. Therefore, females of childbearing potential and their male partners must be willing to use an effective method of contraception during the clinical study (hormonal, barrier, surgical, or abstinence) before study enrollment and for 6 months after the last dose of the study drug. If the female becomes pregnant or suspects she is pregnant while participating in this study, she must inform her treating physician immediately.\n* Agreeable to undergo craniotomy for brain biopsy and\u002For resection\n\n  --Initial diagnostic biopsy under 03-N-0164 to confirm recurrent disease and obtain pre-treatment tissue. Only participants who were not expected to able to achieve a gross total resection of tumor will be included in the study.\n* Willing and able to appoint a durable power of attorney\n* Able to provide informed consent or have a legally authorized representative (LAR) to provide consent, if incapacitated.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant and\u002For nursing females\n\n  --As LMP744 is a novel agent with the potential for teratogenic or abortifacient effects, pregnant and\u002For nursing females will be excluded from receiving drug\n* Significant medical co-morbidities that would compromise the participant s ability to tolerate LMP744 and which cannot reasonably be controlled (per the investigator s judgment, such as poorly controlled chronic kidney disease and\u002For poorly controlled congestive heart failure)\n* Social situations that would limit compliance with study requirements, such as chronic homelessness\n* Prior chemotherapy or biologic therapy completed within 4 weeks (6 weeks for nitrosoureas and mitomycin C) or a duration of 5 half-lives (whichever is shorter)\n* Additional malignancy diagnosed or requiring active treatment within 1 year of screening\n* Unable to undergo an MRI scan of the brain\n* Active autoimmune disease that requires systemic treatment within 2 years of screening\n* Cardiac disease\n\n  * \\>=2 MIs\n  * \\>=2 coronary revascularization procedures\n  * Cardiac Troponin T or I \\>= 2x the institutional upper limit of normal at screening\n  * Ejection fraction \\\u003C45% on screening echocardiogram\n* Chronic hypokalemia (K\\\u003C2.5 mmol\u002FL)\n* Human Immunodeficiency Virus (HIV)\n\n  * Known history of HIV\n  * Positive HIV 1\u002F2 at screening.\n* Active Hepatitis B or Hepatitis C infection at screening\n* Active infection requiring systemic antibacterial, antiviral or antifungal therapy \\\u003C7 days prior to initiation of study drug\n* Recipient of autologous or allogeneic T cells\n* Solid organ or tissue transplant recipients","ALL","18 Years","99 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\nGlioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells.\n\nObjective:\n\nTo test LMP744 in people with glioblastoma.\n\nEligibility:\n\nPeople aged 18 years or older with glioblastoma that returned after treatment.\n\nDesign:\n\nParticipants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function.\n\nParticipants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein.\n\nLMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time.\n\nParticipants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery.\n\nParticipants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits.\n\nParticipants will continue to have telehealth visits every 3 months after they stop taking the drug.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Recurrent Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Relapsed Cancer","Recurrent Tumor","Glioblastoma Multiforme","Recurring Glioblastoma","Brain and Central Nervous System Tumors","Glioma","Glioblastomas","Grade IV Astrocytoma","GBM","Recurrent Glioma (Glioblastoma Multiforme)","High Grade Glioma","Glioma, Malignant","Brain Cancer",[29,36,45,46,47,48,49,50,43],"Neoplasms","Neoplasms, Nerve Tissue","Neoplasms by Histological Type","Glioblastoma Multiforme (GBM)","Phase I","Phase II","RECRUITING","2026-07-10",{"date":54,"type":55},"2026-07-13","ACTUAL",{"date":57,"type":22},"2026-07-16",{"date":59,"type":22},"2032-12-31",{"name":61,"class":62},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":65,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":66,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":27,"conditions":68,"keywords":69,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":76,"locationsCount":63},"100624942",{"count":21,"type":22},[25,26],[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],[29,36,45,46,47,48,49,50,43],"2026-07-01",{"date":72,"type":55},"2026-07-02",{"date":74,"type":22},"2026-07-07",{"date":59,"type":22},{"name":61,"class":62},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":63},"100609136","early-phase-1-window-trial-of-fluorescently-labeled-nivolumab-irdye800-nivo800-in-high-grade-glioma-hgg-100609136","NCT07210632","Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Patient must have imaging of highly suspicious high grade glioma (HGG)\n4. Patients for whom surgical craniotomy is planned as standard of care (SOC)\n5. Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) AST 9-80 (IU\u002FL) ALT 7-110 (IU\u002FL) BUN 6-50 (mg\u002FdL) Creatinine 0.5-3.0 (mg\u002FdL)\n\nExclusion Criteria:\n\n1. Patients not eligible for SOC surgical resection\n2. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n   Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n\n   Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n   Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n   Rash must cover \\\u003C 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\n   History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n6. Prior allogeneic stem cell or solid organ transplantation\n7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n8. Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n   Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n\n   Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n\n   Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n\n   Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n\n   Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment.\n10. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.",{"count":84,"type":22},38,[86],"EARLY_PHASE1","High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.",[43,89,36,41,90,91,92],"HGG","High Grade Gliomas","High Grade Glioma (III or IV)","High Grade Glioma (HGG) of the Brain With BRAF Aberration",[94,95],"hgg","high grade glioma","2026-06-29",{"date":70,"type":55},{"date":99,"type":55},"2026-03-27",{"date":101,"type":22},"2031-03-30",{"name":103,"class":104},"Eben Rosenthal","OTHER",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":63},"100630882","early-phase-1-pilot-study-evaluating-panitumumab-irdye800-as-an-optical-imaging-agent-to-detect-intracranial-lesions-during-neurosurgical-procedures-100630882","NCT07493447","Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures","Inclusion Criteria:\n\n* Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and\u002For radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.\n* Subject age ≥ 18 years.\n* Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:\n\n  1. Chemistry Panel - Potassium, BUN (or urea), and Creatinine\n  2. CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count\n  3. Magnesium and Phosphorus\n* Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.\n* Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.\n\nExclusion Criteria:\n\n* Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.\n* History of infusion reactions to any monoclonal antibody therapies.\n* Women who are currently pregnant or breastfeeding.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.\n* Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.\n* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n* Patients with severe renal disease or anuria",{"count":112,"type":22},30,[86],"This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.",[116,117,118,43,119],"Meningioma","Glioblastoma","Acoustic Neuroma","Pituitary Adenoma",[121,122,123,117,116,119,118,124,125],"Cancer","Malignant","Benign","Brain Masses","Intracranial Lesion","2026-06-26",{"date":128,"type":55},"2026-06-30",{"date":130,"type":22},"2026-07",{"date":132,"type":22},"2031-06",{"name":103,"class":104},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":172},"100618049","phase-2-study-of-silevertinib-with-temozolomide-for-the-treatment-of-newly-diagnosed-gbm-with-unmethylated-mgmt-and-egfrviii-100618049","NCT07326566","Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","Key Inclusion Criteria:\n\n* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).\n* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).\n* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.\n* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.\n* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.\n* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.\n* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.\n\nKey Exclusion Criteria:\n\n* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.\n* Progression of GBM prior to Enrollment, Screening, or Randomization.\n* Biopsy-only\u002Fno resectional surgery.\n* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.\n* Intent to use Optune® (TTF).\n* Significant other uncontrolled health conditions or other malignancies.",{"count":142,"type":22},162,[26],"The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.\n\nSpecifically, this study is being done to find answers to the following questions:\n\n* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?\n* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?\n* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?",[146,147,39,48,36,148,43],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","Central Nervous System Diseases",[150,117,151,152,153,154,155,156,157,158,159,160,161],"EGFR","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","temozolomide","Temodar","silevertinib","BDTX-1535","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)","2026-06-18",{"date":164,"type":55},"2026-06-22",{"date":166,"type":55},"2026-05-05",{"date":168,"type":22},"2029-03",{"name":170,"class":171},"Black Diamond Therapeutics, Inc.","INDUSTRY",14,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":183,"conditions":184,"keywords":200,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100431578","phase-2-stereotactic-brain-directed-radiation-with-or-without-aguix-gadolinium-based-nanoparticles-in-brain-metastases-100431578","NCT04899908","Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases","A Double-blind, Phase II Randomized Study of Brain-directed Stereotactic Radiation With or Without AGuIX Gadolinium-based Nanoparticles in the Management of Brain Metastases at Higher Risk of Local Recurrence With Radiation Alone","Inclusion Criteria:\n\n* Participants must have a biopsy proven solid malignancy and at least one intracranial measurable lesion spanning ≥5mm in maximal unidimensional size and radiographically consistent with or pathologically proven to be a brain metastasis AND meet one of the following additional criteria regarding the primary site or nature of the intracranial disease:\n\n  * Melanoma with intracranial growth consistent with tumor progression despite immunotherapy\n  * Gastrointestinal primary\n  * HER2 positive breast cancer (subtype assessed using most representative tissue available in opinion of enrolling clinician and\u002For study PI)\n  * Cystic metastases\n  * Metastases ≥2cm in maximal unidimensional size\n  * Locally recurrent metastases after prior stereotactic radiation\n  * Locally recurrent metastases after prior whole brain radiation \\*Patients with metastases from melanoma, GI primaries, or HER2+ breast cancer, as well as those with cystic metastases or metastases ≥2cm in maximal unidimensional size, who have local recurrences after prior brain-directed radiation can only be treated in the strata permitting prior radiation (last two strata above)\n* Age ≥18 years at diagnosis of brain metastases\n* Estimated glomerular filtration rate of ≥ 60 mL\u002Fmin\u002F1.73m2\n* Karnofsky performance status of at least 70 (i.e. at minimum, \"cares for self\" but \"unable to carry on normal activity or do active work\")\n* Estimated survival based on extracranial disease of at least 3 months in the opinion of the enrolling clinician and\u002For study PI\n* Ability to understand and the willingness to sign a written informed consent document\n* The effects of AGuIX on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception prior to study entry and for the duration of the therapeutic component of study participation\n\nExclusion Criteria:\n\n* Participants who cannot undergo a brain MRI\n* Participants who cannot receive gadolinium\n* Participants with widespread, definitive leptomeningeal disease\n* Patients requiring radiation to either \\>10 targets (if naïve to whole brain radiation) or \\>20 targets (if whole brain radiation has been given previously) per the discretion of the treating clinician and\u002For study PI\n* Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study\n* In cohorts who have received prior brain-directed radiation, patients are not eligible for this study if they have active (at the time of protocol screening) brain metastases that require radiation that are in or within 1.0cm of the brainstem, eyes, optic nerves, or optic chiasm if the juxtaposed organ at risk (i.e. brainstem, eyes, optic nerves, or optic chiasm) has previously received either \\>6.0 Gy in a single fraction or, if prior radiation was fractionated, a cumulative dose in 2.0 Gy equivalents, using an alpha\u002Fbeta ratio of 2, of \\>40.0 Gy. In addition, all patients who have had prior brain-directed radiation, regardless of technique\u002Fdose\u002Ffractionation, are not eligible for the study until written approval is provided by the study\u002Fsite PI",{"count":181,"type":22},134,[26],"The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.",[43,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199],"Brain Metastases","Melanoma","Lung Cancer","Breast Cancer","HER2-positive Breast Cancer","Colorectal Cancer","Gastrointestinal Cancer","SRS","SRT","Whole Brain Radiation","Stereotactic Radiation","AGuIX","Nanoparticle","Cystic","Brain Tumor",[43,185,186,187,188,189,190,191,192,193,201,195,196,197,198,199],"Whole brain radiation","2026-06-16",{"date":204,"type":55},"2026-06-17",{"date":206,"type":55},"2021-09-15",{"date":208,"type":22},"2029-05",{"name":210,"class":104},"Brigham and Women's Hospital",2,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":23,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":234,"leadSponsor":236,"locationsCount":63},"100640528","phase-1-vorasidenib-with-lomustine-in-patients-with-recurrent-idh-mutant-glioma-harboring-idh1-andor-idh2-mutations-100640528","NCT07629089","VorAsidenib With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and\u002For IDH2 Mutations","VALIENT: Phase 1 Clinical Trial of VorAsidenib in Combination With Lomustine In Patients With rEcurrent IDH-mutaNT Glioma Harboring IDH1 and\u002For IDH2 Mutations","VALIENT","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment:\n\n1. Age ≥18 years.\n2. Karnofsky performance status score of ≥ 60%.\n3. Be able to understand and willing to sign informed consent or assent as determined by local requirements.\n4. Be willing to comply with scheduled visits, treatment plans, and laboratory tests, including serial peripheral blood sampling and during the study.\n5. Must have recurrent IDH-mutant oligodendroglioma or astrocytoma grade 2-4 harboring IDH1 and\u002For IDH2 mutation per WHO 2021 criteria (Louis et al, 2021).\n6. Must have IDH1 (IDH1 R132H\u002FC\u002FG\u002FS\u002FL mutation variants tested) and\u002For IDH2 (IDH2 R172K\u002FM\u002FW\u002FS\u002FG mutation variants tested) mutation(s) as determined by standard of care local testing.\n7. Must have available 1p\u002F19q and tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) status available from a pathological report as per standard of care local testing.\n8. Have presence of measurable disease based on RANO2.0 criteria AND imaging review meeting definition of progression of disease as per RANO2.0 criteria (see Section 10.1.1 for more information).\n\n   o Note: Contrast enhancing disease will be allowed.\n9. Participants must have received appropriate standard of care treatment options (in the opinion of the treating investigator) with at least 1 prior surgery (biopsy, subtotal resection, gross-total resection) and 1 prior treatment (radiation, chemotherapy).\n\n   o Note: Prior exposure to IDH-inhibitors will be allowed.\n10. Have expected survival of ≥3 months.\n11. Sexually active fertile subjects and their partners must agree to use a highly effective method of contraception prior to study entry, during the course of the study, and for 90 days after the last dose of vorasidenib or 3.5 months after the last dose of lomustine, (whichever is later). Females of reproductive potential should be advised to use effective non-hormonal contraception during treatment with vorasidenib, since vorasidenib can redner some hormonal contraceptives ineffective. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n12. Female subjects of childbearing potential (FOCBP) must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n    o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n13. Must have normal organ and marrow function as defined below:\n\n    * Hemoglobin ≥ 9.0 g\u002FdL\n    * Absolute neutrophil count ≥ 1,500\u002FmcL\n    * Platelet count ≥ 100,000\u002FmcL\n    * Serum total bilirubin ≤1.5 × upper limit of reference range (ULN); if \\>1.5 × ULN and due to Gilbert syndrome, total bilirubin ≤3×ULN with direct bilirubin ≤ULN\n    * Aspartate aminotransferase (AST) at or below ULN\n    * Alanine aminotransferase (ALT) at or below ULN\n    * Alkaline phosphatase (ALP) ≤2.5 X institutional ULN\n    * Serum creatinine ≤ 2.0 × ULN, OR Creatinine clearance \\> 40 mL\u002Fmin based on the Cockcroft-Gault glomerular filtration rate estimation: (140 - Age) × (Weight in kg) × (0.85 if female) \u002F 72 × Serum Creatinine\n14. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.\n15. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within six (6) months are eligible for this trial.\n16. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n17. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\nExclusion Criteria:\n\n1. Patients who have not recovered to grade 0 or 1 or pre-treatment baseline from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia.\n2. Presence of extracranial metastatic or leptomeningeal disease.\n3. Have had any prior anticancer therapy within 28-days of treatment other than surgery (biopsy, sub-total resection, gross- total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.\n4. Early progression prior to 3 months from completion of radiotherapy.\n5. Have features assessed as high-risk by the Investigator, including:\n\n   * Brainstem involvement either as primary location or by tumor extension\n   * Clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed)\n   * Uncontrolled seizures (defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).\n6. Concurrent active malignancy except for:\n\n   * Curatively resected non-melanoma skin cancer\n   * Curatively treated carcinoma in situ.\n   * Note: Subjects with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.\n7. Are pregnant or breastfeeding.\n8. Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.\n9. Have a known hypersensitivity to any of the components of vorasidenib or lomustine.\n10. Have a heart-rate corrected QT interval using Fridericia's formula (QTcF) ≥450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome).\n\n    o Note: Subjects with bundle branch block and prolonged QTcF are permitted with approval of the principal investigator.\n11. Are taking therapeutic doses of steroids at a dexamethasone equivalent of \\> 4mg\u002Fday for signs\u002Fsymptoms of glioma.\n\n    o Note: Subjects taking physiologic doses (defined as equivalent of ≤10 mg prednisone daily) for medical conditions not related to glioma will be permitted.\n12. Are taking any medications that are cytochrome CYP2C19, or CYP3A substrates with a narrow therapeutic index or strong inhibitors of CYP1A2. (Subjects should be transferred to other medications before receiving the first dose of study drug.)\n13. Are unable to swallow pills or have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or lap band dysphagia, short-gut syndrome, gastroparesis, or other condition that limits the ingestion or gastrointestinal absorption of drugs administered orally.\n\n    o Note: Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).\n14. Previous treatment with bevacizumab for the treatment of glioma with therapeutic intent, or with bevacizumab as supportive therapy (e.g., edema reduction) within six (6) weeks (42 days) of initiation of study treatment.\n15. Have any other acute or chronic medical or psychiatric condition, including recent (within 12 months of C1D1) or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.",{"count":221,"type":22},24,[25],"This study will test the hypothesis that vorasidenib in combination with lomustine will be safe and tolerable. The overall goal of this study is to identify the optimal vorasidenib dose that can be tested in a subsequent phase 2 study to determine the efficacy of vorasidenib in combination with lomustine in patients with recurrent IDH mutant gliomas.",[43],[226,227,228],"isocitrate dehydrogenase (IDH)","IDH mutations","glioma","NOT_YET_RECRUITING","2026-06-02",{"date":232,"type":55},"2026-06-05",{"date":128,"type":22},{"date":235,"type":22},"2035-06-30",{"name":237,"class":104},"Megan Mantica",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":250,"conditions":251,"keywords":252,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":211},"100638970","living-well-with-brain-cancer-a-group-based-intervention-to-promote-whole-person-well-being-100638970","NCT07628647","Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being","Pilot Study of the Living Well With Brain Cancer Intervention","LWBC","Inclusion Criteria:\n\n* Currently living in the United States\n* Aged 18 years or older\n* Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)\n* Treating prescribing provider who follows regularly with participant\n\nExclusion Criteria:\n\n* \\\u003C1 month since initial diagnosis and\u002For \\\u003C1 month since surgical resection\n* Enrollment in hospice\n* Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed\n* Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)\n* Not able to communicate in English at a conversational level",{"count":247,"type":22},64,[249],"NA","The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:\n\n* Is it feasible to conduct this program?\n* Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?",[43],[253,117,254,255,256,257,258,36,259],"Brain cancer","Astrocytoma","Ependymoma","Oligodendroglioma","Brain tumor","Mental health","Quality of life",{"date":232,"type":55},{"date":262,"type":22},"2026-06",{"date":264,"type":22},"2027-10-31",{"name":266,"class":104},"University of Colorado, Denver",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":63},"100512623","surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-glioblastoma-100512623","NCT05954858","Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma","Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).\n2. TPFF and\u002For pericranial flap is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n3. Subject intends to participate in another clinical trial\n4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n5. Subject has an active infection requiring treatment.\n6. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n7. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n8. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n9. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":275,"type":22},32,[249],"This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.\n\nThe objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).",[42,117,33,279,41,39,43],"Glioblastoma Multiforme, Adult",[281,282,283,284],"tissue autograft","blood brain barrier","pedicled temporoparietal fascial","pericranial flap","2026-05-28",{"date":287,"type":55},"2026-06-01",{"date":289,"type":55},"2023-06-29",{"date":291,"type":22},"2029-06-30",{"name":293,"class":104},"Northwell Health",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":63},"100514481","omental-tissue-autograft-in-human-recurrent-glioblastoma-multiforme-rgbm-100514481","NCT05979064","Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)","Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).\n2. Omental graft is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject intends to participate in another clinical trial.\n3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.\n10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.\n11. Subject who are unable to have an MRI scan for any reason.",{"count":302,"type":22},10,[249],"This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.",[36,42,117,33,306,39,43,41],"Glioblastoma Multiforme of Brain",[282,308,309,310,311],"omentum autograft","omental autograft","omentum","omental",{"date":287,"type":55},{"date":314,"type":55},"2023-04-04",{"date":316,"type":22},"2028-04",{"name":293,"class":104},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":63},"100460101","phase-3-repeated-superselective-intraarterial-cerebral-infusion-siaci-of-bevacizumab-with-temozolomide-and-radiation-compared-to-temozolomide-and-radiation-alone-in-newly-diagnosed-gbm-100460101","NCT05271240","Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM","A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Subject must be able to undergo MRI evaluation.\n6. Subject meets the following laboratory criteria:\n\n   i. White blood count ≥ 3,000\u002FμL ii. Absolute neutrophil count ≥ 1,500\u002FμL iii. Platelets ≥ 100,000\u002FμL iv. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).\n\nExclusion Criteria:\n\n1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.\n3. Subject intends to participate in another clinical trial\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject, if female, is pregnant or is breast feeding.",{"count":326,"type":22},432,[328],"PHASE3","Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology.\n\nThe investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg\u002Fkg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I\u002FII clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.",[117,33,42,39,43,331,279],"Glioblastoma, IDH-wildtype",{"date":287,"type":55},{"date":334,"type":55},"2022-04-27",{"date":336,"type":22},"2028-04-01",{"name":293,"class":104},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":356,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":63},"100302121","phase-1-oral-capecitabine-and-temozolomide-captem-for-newly-diagnosed-gbm-100302121","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.","74 Years",{"count":348,"type":22},67,[25,26],"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.",[48,117,352,353,199,354,355,121,43],"Glioma of Brain","Glioblastoma, Adult","Brain Tumor, Primary","Brain Tumor Adult",{"date":287,"type":55},{"date":358,"type":55},"2017-06-13",{"date":360,"type":22},"2029-06",{"name":293,"class":104},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":371,"briefSummary":372,"conditions":373,"keywords":377,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":63},"100275179","phase-1-super-selective-intra-arterial-repeated-infusion-of-cetuximab-for-the-treatment-of-newly-diagnosed-glioblastoma-100275179","NCT02861898","Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Phase I\u002FII Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age.\n* Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)\n* Patients with pathology confirmed histologic EGFR overexpression\n* Patients must have at least one confirmed and evaluable tumor site.∗\n\n  \\*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.\n* Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.\n* No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.\n* Patients must have adequate hematologic reserve with WBC≥3000\u002Fmm3, absolute neutrophils ≥1500\u002Fmm3 and platelets ≥100,000\u002F mm3. Patients who are on Coumadin must have a platelet count of ≥150,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5X the institutional upper limit of normal (IUNL); AST or ALT\\\u003C2.5X IUNL and creatinine\\\u003C1.5X IUNL.\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.\n* Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Women of childbearing potential and fertile men will be informed as to the potential risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.\n* Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring\n* Patients with radiological evidence of leptomeningeal disease.\n* Patients with history of allergic reaction to CTX\n* Patients who initiated or completed chemo\u002FRT",{"count":370,"type":22},33,[25,26],"Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol).\n\nThis trial will be a non-randomized open label Phase I\u002FII clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.",[117,43,374,199,375,376,39],"Brain Neoplasm","Brain Neoplasm, Malignant","EGFR Gene Overexpression",[150,378,160],"Epidermal Growth Factor Receptor",{"date":287,"type":55},{"date":381,"type":4},"2016-06",{"date":383,"type":22},"2029-12",{"name":293,"class":104},{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":391,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":395,"briefSummary":396,"conditions":397,"keywords":403,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":63},"100621751","observational-study-of-responses-to-treatments-in-advanced-central-nervous-system-cns-tumors-100621751","NCT07374692","Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors","* INCLUSION CRITERIA\n* Participants must have advanced CNS tumors confirmed by a documented pathology report, including:\n\n  * recurrent isocitrate dehydrogenase (IDH)-wild-type high-grade glioma\n  * recurrent IDH-mutant gliomas\n  * other recurrent CNS tumors\n* Participants must have been scheduled for a brain tumor biopsy or resection. Note: Scheduled brain tumor biopsy or resection must be at least 6 months after any previous radiation therapy, if applicable. All procedures are planned to take place at NIH.\n* Age \\>= 15 years.\n* Ability of participant, parent\u002Fguardian, or Legally Authorized Representative (LAR) to understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nNone.","15 Years","120 Years",{"count":394,"type":22},80,[249],"Background:\n\nPrimary central nervous system (CNS) tumors grow in the brain and spinal cord. These tumors are rare, but they are difficult to treat and often fatal. SmartMatch is a new technology that tries to help find the best medicines for the particular tumor by testing how small pieces of surgically removed tumor tissue react to different drugs. The study team wants to see if SmartMatch can complete the analysis and generate a report within 21 days from the time of the surgery.\n\nObjective:\n\nTo better understand CNS tumors so doctors can find better ways to treat them in the future.\n\nEligibility:\n\nPeople aged 15 years and older with recurrent CNS tumors. Patient must already be scheduled for a surgery for the tumor at the NIH.\n\nDesign:\n\nThe study team will collect a small amount of tumor samples during the planned surgery. They may also use tumor samples from previous procedures. No new or additional procedures will be done for the purpose of this study.\n\nThe tumor samples will be sent to a lab for SmartMatch analysis. Once completed, the results will be shared with the patient and his\u002Fher local doctor. Together they can decide whether to incorporate the results into the treatment plan. It is important to know that the results may or may not be helpful.\n\nThere will only be one blood test for research. Blood and tissue samples collected may be used for additional analysis. Tumor tissue may be used to grow additional samples for further study. Participants will receive a pathology diagnosis and mutation profile generated by pathologists who specialize in CNS tumors.\n\nThe study team will seek updates on participant's health approximately every 6 months for 3 years. Tumor samples may also be collected from any additional surgery done at NIH during this time....",[398,43,399,400,401,402],"Recurrent CNS Tumors","Gliomas","IDH-wildtype Gliomas","IDH-mutant Gliomas","Rare CNS Tumor",[404,199,405,406,399,407],"CNS Tumor","Rare Tumor","SmartMatch","Drug Screen","2026-05-21",{"date":410,"type":55},"2026-05-22",{"date":412,"type":55},"2026-02-04",{"date":414,"type":22},"2030-12-30",{"name":416,"class":62},"National Cancer Institute (NCI)",{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":23,"phases":427,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":63},"100519787","phase-1-18f-fluciclovine-pet-amino-acid-evaluation-of-brain-metastasis-treated-with-stereotactic-radiosurgery-100519787","NCT06048094","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery","18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery (FACILITATE)","FACILITATE","Inclusion Criteria:\n\n* Diagnosis of cancer with radiographic finding of brain metastasis\n* Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension\n* Planned treatment with SRS as per the treating physician team\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an additional 1 week following the last 18F-fluciclovine PET\n\nExclusion Criteria:\n\n* Prior anaphylactic reaction to 18F-fluciclovine\n* Radiographic evidence of leptomeningeal disease\n* Prior whole-brain radiation therapy\n* Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n* Pregnant or positive serum pregnancy test within 14 days of registration\n* Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 24 hours after the time of imaging is allowed.\n* Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol and\u002For preclude informed consent\\*\n\n  * A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the protocol.",{"count":426,"type":22},46,[25],"This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.",[185,430,43],"Brain Metastases, Adult",[432,433,434],"stereotactic radiosurgery","18F-flucicloivine","PET imaging","2026-05-18",{"date":437,"type":55},"2026-05-20",{"date":439,"type":55},"2024-04-11",{"date":441,"type":22},"2033-05",{"name":443,"class":104},"Baptist Health South Florida",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":448,"acronym":449,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":453,"phases":4,"briefSummary":454,"conditions":455,"keywords":463,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":435,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100453457","learn-learning-environment-for-artificial-intelligence-in-radiotherapy-new-technology-100453457","NCT05184790","LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology","LEARN","Inclusion Criteria:\n\n* Will receive radiation therapy for brain, breast, head and neck, kidney, liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment at a participating centre.\n* Will receive CT planning, and a cone beam CT scan for at least one fraction of radiation therapy.\n* Will receive intrafraction x-ray imaging for the liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment. As intrafraction imaging is not common standard of care for brain, breast, head and neck and kidney cancer treatments there is no requirement to have intrafraction x-ray imaging data for these anatomical sites.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years of age",{"count":452,"type":22},300,"OBSERVATIONAL","This study will develop a whole-of-body markerless tracking method for measuring the motion of the tumour and surrounding organs during radiation therapy to enable real-time image guidance.\n\nRoutinely acquired patient data will be used to improve the training, testing and accuracy of a whole-of-body markerless tracking method. When the markerless tracking method is sufficiently advanced, according to the PI of each of the data collection sites, the markerless tracking method will be run in parallel to, but not intervening with, patient treatments during data acquisition.",[456,188,457,43,458,459,460,461,462],"Arrhythmias, Cardiac","Prostatic Cancer","Kidney Cancer","Head and Neck Cancer","Liver Cancer","Pancreatic Cancer","Spinal Neoplasm",[464,465],"Radiation Therapy","markerless tracking",{"date":467,"type":55},"2026-05-19",{"date":469,"type":55},"2023-02-28",{"date":471,"type":22},"2028-01-31",{"name":473,"class":104},"University of Sydney",4,{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":63},"100632320","precision-radiotherapy-enabled-by-molecular-mri-100632320","NCT07512154","Precision Radiotherapy Enabled by Molecular MRI","Inclusion Criteria:\n\n* Histologic confirmation of glioblastoma or grade 4 astrocytoma\n* Age \\>18\n* KPS at least 60\n* Patients must have normal organ and marrow function as defined below:\n\n  * leukocytes \\>3,000\u002FmcL\n  * absolute neutrophil count \\>1,500\u002FmcL\n  * platelets \\>100,000\u002FmcL\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C2.5\n  * institutional upper limit of normal\n  * creatinine within normal institutional limits OR creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional normal.\n* Patients of child-bearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are unable to receive MRIs will be excluded from the study.\n* Patients may not be receiving any other investigational cancer treatment agents at the time of enrollment.\n* Patients may not have previously been treated with an overlapping course of radiotherapy to the brain.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and\u002For breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 12 weeks after the study are excluded. Male subjects must also agree to use effective contraception for the same period as above.",{"count":482,"type":22},20,[249],"This is a research study to determine if a novel molecular magnetic resonance imaging (MRI) technique, called amide proton transfer (APT) imaging, is useful in identifying the most aggressive areas of tumor needed for radiotherapy of brain tumors.",[43],[117],{"date":488,"type":55},"2026-05-06",{"date":490,"type":55},"2026-04-29",{"date":492,"type":22},"2032-05",{"name":494,"class":104},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":502,"sex":17,"minAge":18,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":505,"briefSummary":506,"conditions":507,"keywords":509,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":63},"100441061","a-study-to-measure-the-effect-of-brain-stimulation-on-hand-strength-and-function-in-patients-with-brain-tumors-100441061","NCT05023434","A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors","The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies","AWAKE CRANIOTOMY COHORT\n\nInclusion Criteria:\n\n1. Age 18 - 75\n2. Ability to understand a written informed consent document, and the willingness to sign it\n3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.\n4. Karnofsky performance status (KPS) ≥ 70\n5. Normal or near normal motor strength (i.e., at least 3\u002F5 in relevant areas)\n6. Normal or near normal speech (Can consistently name at least 4\u002F5 cards)\n7. Free of other illness, in the judgment of the investigator, that may shorten life expectancy\n8. Willing and able to participate in all aspects of the study\n\nExclusion Criteria:\n\n1. Presence of other malignancy not in remission\n2. Evidence of bi-hemispheric or widespread tumor involvement\n3. Medically high-risk surgical candidate\n4. History of recent scalp or systemic infection\n5. Presence of other implants or foreign bodies in the head\n6. Inability to receive an MRI for any reason\n7. Inability to receive cortical stimulation for any reason\n8. Presence of implanted cardiac device (such as a pacemaker or defibrillator)",true,"75 Years",{"count":482,"type":22},[249],"The neurosurgical standard of care for treating a patient with a tumor invading hand primary motor cortex (M1) includes performing a craniotomy with intraoperative direct electrical stimulation (DES) mapping and to resect as much tumor as possible without a resultant permanent neurological deficit. However, the subjective nature of current intraoperative hand motor assessments do not offer a comprehensive understanding of how hand strength and function may be impacted by resection. Additionally, there is a paucity of data to inform how altering DES parameters may effect motor mapping. Here, the investigators seek to demonstrate a feasible, standardized protocol to quantitatively assess hand strength and function and systematically assess several stimulation parameters to improve intraoperative measurements and better understand how cortical stimulation interacts with underlying neural function.",[199,43,508],"Motor Cortex; Lesion",[510,511,512,513,514,515,516,517,518,519],"Brain Stimulation","Cortex Stimulation","Hand Motor Cortex","Primary Motor Cortex","M1","Resection","Surgery","Healthy Volunteers","Hand Strength","Hand Function",{"date":521,"type":55},"2026-05-11",{"date":523,"type":55},"2023-04-17",{"date":525,"type":22},"2028-12-01",{"name":527,"class":104},"Medical College of Wisconsin",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":63},"100415393","phase-1-assess-use-of-18f-fluciclovine-for-patients-with-large-brain-metastases-treated-with-staged-stereotactic-radiosurgery-100415393","NCT04689048","Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery","Characterization of Large Brain Metastases With 18F-Fluciclovine PET\u002FCT Treated With Staged Stereotactic Radiosurgery","Inclusion Criteria:\n\n1. Male or female, age ≥18 years\n2. Performance status, Eastern Cooperative Oncology Group 0-2\n3. Confirmed diagnosis of brain metastases with at least one untreated lesion \\>2 cm in maximum diameter\n4. Plan for SSRS per the treating team\n5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required\n6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography\u002Fcomputerized tomography\n\nExclusion Criteria:\n\n1. Prior anaphylactic reaction to 18F-fluciclovine\n2. Evidence of leptomeningeal disease\n3. Prior whole-brain radiation therapy\n4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)\n5. Females pregnant at the expected time of 18F-fluciclovine administration\n6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed\n7. Major medical illness or psychiatric\u002Fcognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and\u002For preclude informed consent",{"count":482,"type":22},[25],"The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.",[430,185,43],[540,541,542,543,544],"brain","brain metastases","brain metastases, adult","brain cancer","Stereotactic Radiosurgery","2026-04-20",{"date":547,"type":55},"2026-04-22",{"date":549,"type":55},"2022-04-04",{"date":551,"type":22},"2027-12",{"name":443,"class":104},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":562,"briefSummary":563,"conditions":564,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":63},"100270475","phase-2-super-selective-intra-arterial-repeated-infusion-of-cetuximab-erbitux-with-reirradiation-for-treatment-of-relapsedrefractory-gbm-aa-and-aoa-100270475","NCT02800486","Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed\u002FRefractory GBM, AA, and AOA","Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed\u002FRefractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma","Inclusion Criteria:\n\n* Male or female patients of ≥18 years of age\n* Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)\n* Patients with pathology confirmed histologic EGFR overexpression\n* Patients must have at least one confirmed and evaluable tumor site.∗\n\n  \\*A confirmed tumor site is one in which is biopsy-proven\n* Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.\n* No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol\n* Patients must have adequate hematologic reserve with WBC≥3000\u002Fmm3, absolute neutrophils ≥1500\u002Fmm3 and platelets ≥100,000\u002F mm3. Patients who are on Coumadin must have a platelet count of ≥150,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5X the institutional upper limit of normal (IUNL); AST or ALT\\\u003C2.5X IUNL and creatinine\\\u003C1.5X IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL\n* Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating.\n* Women of childbearing potential and fertile men will be informed of the potential unknown risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period\n* Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring\n* Patients with radiological evidence of leptomeningeal disease\n* Patients with history of allergic reaction to CTX\n* Patients who completed chemo\u002FRT less than 6 months prior to enrollment\n* Patients who have not failed standard Stupp protocol",{"count":561,"type":22},37,[26],"Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg\u002Fm2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.",[117,565,566,36,374,43,199,567,375],"Anaplastic Astrocytoma","Anaplastic Oligoastrocytoma","Brain Tumor, Recurrent","2026-04-08",{"date":570,"type":55},"2026-04-13",{"date":572,"type":55},"2016-05",{"date":574,"type":22},"2036-05",{"name":293,"class":104},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":586,"studyType":453,"phases":4,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100368284","the-momentum-study-the-multiple-outcome-evaluation-of-radiation-therapy-using-the-mr-linac-study-100368284","NCT04075305","The MOMENTUM Study: The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","The Multiple Outcome Evaluation of Radiation Therapy Using the MR-Linac Study","MOMENTUM","Inclusion Criteria:\n\n* Patient is to undergo or has completed imaging or treatment procedures on an MR-Linac;\n* Patient provides written, informed consent;\n* Patient is 18 years old or older.\n\nExclusion Criteria:\n\n* MRI exclusion criteria, including\n* MRI contraindications as per usual clinical care, such as (possible) pregnancy; claustrophobia and metal or electronic implants not compatible with MRI.",{"count":585,"type":22},8000,"2 Years","The Multi-OutcoMe EvaluatioN of radiation Therapy Using the Unity MR-Linac Study (MOMENTUM) is a multi-institutional, international registry facilitating evidenced based implementation of the Unity MR-Linac technology and further technical development of the MR-Linac system with the ultimate purpose to improve patients' survival, local, and regional tumor control and quality of life.",[589,188,590,591,199,43,592,593,594,595,596,597,598,599,600,187,601,602,603,604,605,606,607,608,461,609,610,459,611,612,613,45,614,615,460,616,617,618],"Oncology","Prostate Cancer","Gynecologic Cancer","Gynecologic Tumor","Prostate Tumor","Prostate Neoplasm","Breast Tumor","Radiation Toxicity","Quality of Life","Rectal Cancer","Rectal Tumor","Rectal Neoplasms","Lung Tumor","Lung Neoplasm","Esophageal Cancer","Esophagus Cancer","Esophageal Tumor","Esophageal Neoplasm","Esophagus Tumor","Esophagus Neoplasm","Pancreatic Tumor","Pancreatic Neoplasms","Head and Neck Neoplasms","Head and Neck Tumor","Tumor","Bladder Cancer","Bladder Neoplasm","Liver Neoplasms","Liver Metastases","Oligometastases","2026-03-03",{"date":621,"type":55},"2026-03-05",{"date":623,"type":55},"2019-02-01",{"date":625,"type":22},"2030-08-01",{"name":627,"class":104},"UMC Utrecht",18,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":642,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":63},"100520624","phase-2-trastuzumab-deruxtecan-t-dxd-for-people-with-brain-cancer-100520624","NCT06058988","Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer","Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT)","Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection\u002Fbiopsy\n* Pathologically-documented glioblastoma; or\n* Metastatic cancer that:\n\n  o Has a history of Her2 expression or activating Her2-mutation\n* Her2+ defined as 3+ on IHC\n* Her2-low defined as IHC1+ or 2+ and ISH- according to ASCO-CAP 2018 Her2 testing guidelines52\n* Her2 mutations must be described to be activating, occur at a known hotspot (e.g. exon 20 insertions, S310, G660, R678, L755, D769, L777), or involve the transmembrane, juxtamembrane or tyrosine kinase domains\n* Other untreated brain tumors (and prior radiation, including whole-brain and\u002For stereotactic radiation) are allowed\n* Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection\u002Fbiopsy\n* Prior treatments:\n\n  * Cohort A: Brain parenchymal metastases in patients with Her2-expressing\u002FERBB2- activating-mutant cancer with no prior T-DXd exposure (T-DXd naïve)\n  * Cohort B: Brain parenchymal metastases in patients with Her2-expressing\u002FERBB2- activating-mutant cancer with prior T-DXd exposure\n  * Cohort C: Recurrent glioblastoma\n  * For all cohorts: no limit on prior CNS radiation or systemic therapy, including Her2- targeting antibody therapy (including trastuzumab, pertuzumab, trastuzumab emtansine)\n* KPS ≥ 60 Or ECOG \\\u003C 2\n* Life expectancy \\>12 weeks\n* Left ventricular ejection fraction ≥50%\n* Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):\n\n  * Absolute neutrophil count (ANC) ≥1.5 × 103\u002FμL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)\n  * Platelet count ≥10.0x104\u002FμL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x104\u002FμL are not eligible. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 8.0 g\u002FdL. Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g\u002FdL are not eligible (\\> 8 g\u002FdL in gastric cancer \u002F gastroesophageal cancer indications). (Red blood cell transfusion is not allowed within 1 week prior to C1D1)\n  * Serum albumin ≥ 2.5 g\u002FdL\n  * Creatinine clearance ≥30 mL\u002Fmin, as calculated using the Cockcroft-Gault equation\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (\\\u003C5x ULN in participants with liver metastases)\n  * Total bilirubin ≤1.5 × ULN) if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline\n  * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.0xULN unless on medication known to reversibly alter INR and\u002For aPTT\n* Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available within 7 days of the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of T-DXd.\n* Women of childbearing potential are defined as those who are not surgically sterile (i.e.\n\nunderwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy). Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n\n* Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 from the time of screening and must agree to continue using such precautions for 7 months after the last dose of T-DXd. Note: estrogen\u002Fprogesterone is contraindicated in ER+ breast cancer, and in other cancers could increase the risk of DVT. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of T-DXd.\n* Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose ofT-DXd. Complete heterosexual abstinence for the drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use ≥1 highly effective method of contraception throughout this period, as described in Table 1. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of enrollment until 4 months after the last dose of T-DXd; sperm preservation should be considered prior to enrollment in this study.\n* Female subjects must not donate, or retrieve for their own use, ova from the time of enrollment through at least 7 months after the final study drug administration. Preservation of ova may be considered prior to enrollment in this study.\n* Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator.\n\nTable 1: Highly effective methods of contraception (\\\u003C1% failure rate) Non-Hormonal Methods\n\n* Total heterosexual abstinence (evaluate in relation to the duration of the clinical study and the preferred and usual lifestyle choice of the participant)\n* Vasectomised sexual partner (if partner is the sole sexual partner of the trial participant and that the vasectomised partner has received medical assessment of the surgical success)\n* Bilateral tubal occlusion\n* Intrauterine device (provided coils are copper banded)\n\nHormonal Methods\n\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (noting relevant contraindications in ER+ breast cancer, and risk of DVT in other cancers)\n* oral\n* intravaginal\n* transdermal\n* Progestogen-only hormonal contraception associated with inhibition of ovulation\n* oral\n* injectable\n* implantable\n* Intrauterine hormone-releasing system (IUS)\n\nExclusion Criteria:\n\n* Contraindication or history of allergic reaction to T-DXd\n* Significant comorbidities as per investigator evaluation\n* Inability to comply with protocol and\u002For unwilling or not available for follow up assessments or any condition which in the investigator's opinion makes the patient unsuitable for study participation\n* Ferrous or other contraindication to MR imaging\n* History of myocardial infarction within 6 months before enrollment\n* History of symptomatic congestive heart failure (New York Heart Association Class II to IV)\n* Corrected QT interval (QTc) prolongation to \\>470 ms (females) or \\>450 ms (male) based on12-lead electrocardiogram (ECG)\n* Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI\n* History of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis can not be ruled out by baseline chest CT at Screening.\n* Lung criteria:\n\n  1. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)\n  2. Any autoimmune, connective tissue or inflammatory disorders (e.g. Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  3. Prior pneumonectomy (complete)\n* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of T-DXd.\n* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to \\[randomization\u002Fenrollment\u002FCycle 1 Day 1\\] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as:\n\n  1. Chemotherapy-induced neuropathy\n  2. Fatigue\n  3. Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n\n  i. Hypothyroidism\u002Fhyperthyroidism ii. Type 1 diabetes iii. Hyperglycemia iv. Adrenal insufficiency v. Adrenalitis vi. Skin hypopigmentation (vitiligo)\n* Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the Principal Investigator; reactions will be managed per standard institutional protocol\n* History of severe hypersensitivity reactions to other monoclonal antibodies\n* Pregnant or breastfeeding female patients, or patients who are planning to become pregnant.\n* Patients with substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n* Multiple primary malignancies within 3 years, with the exception of:\n\n  1. adequately resected non-melanoma skin cancer\n  2. carcinoma in situ of the cervix\n  3. Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider\n  4. curatively treated in-situ disease\n  5. other solid tumors curatively treated\n  6. contralateral breast cancer \\[patients with metastatic breast cancer\\].\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)",{"count":112,"type":22},[26],"The purpose of this study is to find out how much tratuzumab deruxtecan (T-DXd) can penetrate the tumor when injected into the body, and whether T-DXd may be an effective treatment for brain cancers that express the HER2 protein.",[43,117,640,641,29],"Metastatic Cancer","Leptomeningeal Metastasis",[43,117,640,641,29,643,644,645,646],"Trastuzumab Deruxtecan","T-DXd","22-208","Memorial Sloan Kettering Cancer Center","2026-02-19",{"date":649,"type":55},"2026-02-23",{"date":651,"type":55},"2023-09-22",{"date":653,"type":22},"2027-09-22",{"name":646,"class":104},{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":661,"eligibilityCriteria":662,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":663,"enrollmentInfo":664,"targetDuration":4,"studyType":23,"phases":666,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":679,"completionDateStruct":681,"leadSponsor":683,"locationsCount":4},"100623548","dexmedetomidine-for-postoperative-analgesia-and-delirium-prevention-after-neurosurgery-dex-neuro-trial-100623548","NCT07398066","DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)","DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery: A Double-blinded Randomised Placebo-controlled Trial (DEX-NEURO Trial)","DEX-NEURO","Inclusion Criteria:\n\n* All adult (American Society of Anaesthesiologists (ASA 1-2) who \\>18 years old and \\\u003C65 years old undergoing elective craniotomy\n\nExclusion Criteria:\n\n* Patients who are ASA 3-5 or BMI \\\u003C18\u002F \\>40 or allergic to dexmedetomidine will be excluded. Patients with high-grade heart block or uncontrolled bradyarrhythmia will also be excluded.","65 Years",{"count":665,"type":22},60,[249],"Post-craniotomy pain is common and often undertreated. Inadequate analgesia can lead to patient discomfort and higher opioid consumption, which may result in respiratory depression, sedation risks and impaired neurological assessment in the early postoperative period. The incidence of post-operative delirium after intracranial surgery was 19%, ranging from 12 to 26% caused by variation in clinical features and delirium assessment methods1. It is associated with increased morbidity, longer length of hospital stay, and harm to self or staffs.\n\nDexmedetomidine (Precedex) is a highly selective α2-adrenergic agonist with the properties of analgesia, sedative, anxiolytic and neuroprotection without significant respiratory depression. Most of the trials administered a loading dose of 0.5-1.0 μg\u002Fkg intravenous dexmedetomidine over 10 minutes followed by infusion dose 0.2-0.7 μg\u002Fkg\u002Fhour. The use of intraoperative dexmedetomidine is believed to reduce the usage of postoperative opioids where frequent neurological assessment is often required in neurosurgical patients. Beyond the benefit of analgesia, perioperative dexmedetomidine has been studied for prevention of postoperative delirium. Randomized trials in mixed noncardiac surgical populations reported that low-dose perioperative dexmedetomidine may reduce the incidence of delirium. Dexmedetomidine produces dose-dependent bradycardia and hypotension, which should be carefully monitored to maintain the cerebral perfusion pressure in brain surgery. However, most trials and meta-analyses have focused on general surgical or cardiac cohorts; the evidence remains limited in neurosurgical (craniotomy) patients.\n\nAlthough it showed promising benefits of analgesia and neuroprotection in non-neurosurgical patients, recent meta-analyses of intraoperative dexmedetomidine reported high degree of heterogeneity due to the inclusion of varied procedures (elective vs emergent craniotomy), dosing regimes (loading dose only versus loading dose + infusion versus infusion only) and varied primary endpoints (postoperative pain scores, cumulative opioid consumption or incidence of delirium). Therefore, this randomized, double-blind, placebo-controlled trial is designed to examine the use of intravenous dexmedetomidine in the reduction of postoperative pain score and delirium in neurosurgical patients. We hypothesised that intravenous dexmedetomidine reduces postoperative pain score and delirium with lower need of rescue analgesia and amount of morphine consumption in patients undergoing craniotomy.",[669,43,116],"Neurosurgery",[671,672,673,674,675],"dexmedetomidine","precedex","neurosurgery","delirium","pain","2026-02-02",{"date":678,"type":55},"2026-02-09",{"date":680,"type":22},"2026-07-22",{"date":682,"type":22},"2027-08-22",{"name":684,"class":104},"University of Malaya",{"id":686,"slug":687,"hasResults":12,"nctId":688,"briefTitle":689,"officialTitle":690,"acronym":691,"eligibilityCriteria":692,"healthyVolunteers":502,"sex":17,"minAge":693,"maxAge":4,"enrollmentInfo":694,"targetDuration":4,"studyType":453,"phases":4,"briefSummary":696,"conditions":697,"keywords":709,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":715,"lastUpdatePostDateStruct":716,"startDateStruct":718,"completionDateStruct":720,"leadSponsor":722,"locationsCount":724},"100467447","cfdna-assay-prospective-observational-validation-for-early-cancer-detection-and-minimal-residual-disease-100467447","NCT05366881","cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease","cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse","CAMPERR","Case Inclusion Criteria:\n\n* Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed \\>5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma\n* Able and willing to provide informed consent\n* ≥40 years of age\n\nCase Exclusion Criteria:\n\n* Currently receiving any treatment for cancer\n* Currently taking any demethylating agents\u002FDNA hypomethylating agents\n* Simultaneously diagnosed with two or more invasive cancers\n* Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years\n* Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer\n* Currently diagnosed with any myelodysplastic syndromes and\u002For precursor hematologic conditions (e.g. MGUS) in addition to the index cancer\n* Women who are known to be pregnant (self-reported)\n\nControl Inclusion Criteria\n\n* Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed)\n* Able and willing to provide informed consent\n* ≥40 years of age\n\nControl Exclusion Criteria\n\n* Currently receiving any treatment for cancer\n* Currently taking any demethylating agents\u002FDNA hypomethylating agents\n* Women who are known to be pregnant (self-reported)","40 Years",{"count":695,"type":22},7000,"This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care.\n\nAdditionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.",[43,188,614,698,190,699,603,700,459,701,702,187,703,704,705,461,590,706,707,708],"Cervical Cancer","Endometrial Cancer","Stomach Cancer","Hepatobiliary Cancer","Leukemia","Lymphoma","Multiple Myeloma","Ovarian Cancer","Renal Cancer","Sarcoma","Thyroid Cancer",[710,711,712,713,714],"Multi-cancer early detection","Liquid Biopsy","Methylome","Cancer screening","cell-free DNA","2026-01-16",{"date":717,"type":55},"2026-01-20",{"date":719,"type":55},"2022-05-03",{"date":721,"type":22},"2027-03",{"name":723,"class":171},"Adela, Inc",17,{"id":726,"slug":727,"hasResults":12,"nctId":728,"briefTitle":729,"officialTitle":730,"acronym":4,"eligibilityCriteria":731,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":663,"enrollmentInfo":732,"targetDuration":4,"studyType":23,"phases":734,"briefSummary":735,"conditions":736,"keywords":739,"overallStatus":229,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":749,"completionDateStruct":751,"leadSponsor":753,"locationsCount":4},"100419702","a-study-using-brain-stimulation-and-behavioral-therapy-to-increase-extent-of-resection-in-low-grade-gliomas-100419702","NCT04745156","A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas","Inducing Functional Plasticity in Glioma-Involved Functional Cortex With Deficit-Inducing Cortical Stimulation and Targeted Behavioral Therapy to Increase Extent of Resection","Inclusion Criteria:\n\n1. Age 18-65 years old\n2. Ability to understand a written informed consent document, and the willingness to sign it\n3. Radiographic evidence of likely low-grade glioma on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.\n4. Karnofsky performance status (KPS) ≥ 75\n5. Normal or near normal motor strength (i.e., at least 3\u002F5 in relevant areas)\n6. Normal or near normal speech (Can consistently name at least 4\u002F5 cards)\n7. No medical contraindication to surgery\n8. Free of other illness that may shorten life expectancy\n\nExclusion Criteria:\n\n1. Presence of other malignancy not in remission\n2. Evidence of bi-hemispheric or widespread tumor involvement\n3. Likely candidate to receive GTR on initial resection\n4. Medically high-risk surgical candidate\n5. History of recent scalp or systemic infection\n6. Presence of other implants or foreign bodies in the head\n7. Inability to receive an MRI for any reason\n8. Inability to receive cortical stimulation for any reason\n9. Coagulation disorders and\u002For use of anti-thrombotic therapies\n10. Platelet count \\\u003C 50\n11. Diathermy procedures\n12. Electroconvulsive Therapy (ECT)\n13. Transcranial Magnetic Stimulation (TMS)\n14. Presence of implanted cardiac device (such as a pacemaker or defibrillator)\n15. Pregnant women",{"count":733,"type":22},3,[249],"This study uses a cranial implant to deliver cortical stimulation that, when paired with physiotherapy, will remap the brain so that critical brain functions can be protected during brain tumor surgery. This pilot study will provide initial evidence for the safety and feasibility of such a protocol which will lead to future pivotal trials that could radically change eloquent area brain surgery. For patients with otherwise incompletely resectable brain tumors, this could mean a longer life expectancy and a better quality of life.",[36,737,738,199,43,508],"Glioma Intracranial","Gliomas Benign",[510,740,511,741,742,512,513,514,743,515,516,744,745],"NeuroPace","Neuroplasticity","Plasticity","Motor Mapping","Motor Rehabilitation","Prehabilitation","2026-01-09",{"date":748,"type":55},"2026-01-12",{"date":750,"type":22},"2026-08-01",{"date":752,"type":22},"2027-09",{"name":527,"class":104}]