[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-gbm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-gbm":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,45,78,120,145,176,208,238,303,323,351,389,416,445,468,493,521,542,580,611,639,663,684,707,730],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100577977","phase-2-doc1021-dendritic-cell-immunotherapy-for-treatment-of-newly-diagnosed-adult-glioblastoma-gbm-100577977",false,"NCT06805305","DOC1021 Dendritic Cell Immunotherapy for Treatment of Newly Diagnosed Adult Glioblastoma (GBM)","Randomized Study of DOC1021 Dendritic Cell Immunotherapy in Combination With Standard of Care for Newly Diagnosed Adult Glioblastoma","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age 18 years or older\n4. Presumed diagnosis of glioblastoma IDH-wt (as per the 2021 WHO Classification of CNS Tumors) deemed to be potentially resectable and deemed to be a good candidate for post-operative standard of care temozolomide and radiation therapy.\n\n   1. Surgical objective is for gross total resection (GTR)\u002Fnear-total resection (NTR) de-fined as ≥ 95% of contrast enhancing (CE) tumor removed plus ≤ 1 cm3 residual CE tumor. Patients with subtotal resection will still be eligible if at least 70% of the CE tumor is resected.\n   2. Eligibility will be confirmed after surgery when diagnosis of glioblastoma IDH-wt confirmed prior to randomization. Randomization can occur with only IDH1 immunohistochemistry and when additional molecular testing is available, if glioblastoma IDH-wt is not confirmed, the participant will be deemed a screen failure and replaced.\n   3. Patients with prior biopsy or subtotal resection are eligible if no other anti-cancer treatment received for glioblastoma and additional resection indicated.\n5. Ability to receive filgrastim (e.g., Neupogen), leukapheresis and 3 bi-weekly injections of DOC1021 near deep cervical lymph nodes + weekly pIFN x 6 weeks.\n6. Females of reproductive potential must have a negative serum pregnancy test and agree to use effective contraception (as determined appropriate for the patient by the investigator) during study treatment.\n7. Adequate kidney, liver, bone marrow function, and immune function, as follows:\n\n   1. Hemoglobin ≥ 8.0 gm\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n   3. Platelet count ≥ 75,000\u002Fmm3\n   4. Calculated creatinine clearance (CrCl) \\> 30 mL\u002Fmin using Cockcroft and Gault for-mula:\n\n   i. For males = (140 - age\\[years\\]) x (body weight \\[kg\\]) \u002F (72 x serum creatinine \\[mg\u002FdL\\]) ii. For females = 0.85 x value from male formula e. Total bilirubin ≤ 1.5 times upper limit of normal (ULN) except in patients with Gilbert's disease for which total bilirubin must be ≤ 2 times ULN f. Aspartate transaminase AST (SGOT) and alanine aminotransferase ALT (SGPT) ≤ 3 times the ULN\n8. Karnofsky Performance Score ≥ 70\n\nExclusion Criteria:\n\n1. Infratentorial, recurrent, leptomeningeal or extracranial disease.\n2. Patients who are pregnant or breastfeeding.\n3. Known active HIV or hepatitis infection. Patients with HIV that is well-controlled and have undetectable viral titers remain eligible. Patients with history of HCV adequately treated such that RNA viral load is negative also remain eligible.\n4. Any severe or uncontrolled medical condition or other condition that could affect participation in this study as determined by the investigator, including but not limited to: uncontrolled or severe cardiac disease, systemic autoimmune disorders requiring immunosuppression in the past 2 years\\*, autoimmune hyper\u002Fhypothyroidism, untreated viral hepatitis, autoimmune hepatitis. \\*autoimmune disorders include but are not limited to rheumatoid arthritis, psoriasis and inflammatory bowel disease and immunosuppressive medications include DMARDs like methotrexate, TNF inhibitors, IL-6 receptor blockers, CD80\u002F86 inhibitors, anti-CD20 and JAK inhibitors\n5. Treatment with another investigational drug or other experimental intervention within the last 30 days.","ALL","18 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to learn if DOC1021 + pIFN alongside standard of care (SOC) will improve survival in adult patients newly diagnosed with glioblastoma (IDH-wt). It will also evaluate the safety of DOC1021 + pIFN. Researchers will compare DOC1021 dendritic cell immunotherapy regimen added to SOC compared to SOC treatment alone.\n\nParticipants in the DOC1021 + pIFN + SOC arm will:\n\n* Take filgrastim subcutaneously x 5 doses and subsequently undergo a leukapheresis collection\n* Undergo ultrasound guided perinodal DOC1021 injections every 2 weeks for a total of 3 doses\n* Receive subcutaneous pIFN injections weekly for a total of 6 doses in parallel with the DOC1021 injections\n\nBoth arms of the trial will:\n\n\\- Visit the clinic regularly to assess quality of life, symptoms, medication use, imaging, bloodwork, and to receive SOC treatment with surgery, temozolomide chemotherapy and radiation",[27],"Glioblastoma (GBM)",[29,30,31],"Dendritic Cell Vaccine","Immunotherapy","Tumor vaccine","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2025-03-17",{"date":40,"type":21},"2032-03",{"name":42,"class":43},"Diakonos Oncology Corporation","INDUSTRY",18,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100644629","brain-radiotherapy-imaging-for-high-grade-glioma-using-hypoxia-targeting-through-oxygen-enhanced-response-100644629","NCT07670455","Brain Radiotherapy Imaging for High-grade Glioma Using Hypoxia Targeting Through Oxygen-Enhanced Response","BRIGHTER","Inclusion Criteria:\n\n* ≥18yrs.\n* Participants able to communicate with staff and safely comply with the study procedures.\n* Participants to provide informed written consent.\n\nExclusion Criteria:\n\n* Participants with any MRI contraindications including inability to lie flat in MRI scanner, claustrophobia and no foreign bodies, medical devices or other items which are considered an MRI contraindication.\n* Geographically remote patients unable to agree to imaging schedule.\n* Participants with illness or condition which means they cannot understand the requirements of the study.\n* Participants with cardiac or pulmonary disease that are unable to tolerate the flow of oxygen delivered via a mask.\n* Participants who have previously been treated with bleomycin (a chemotherapy used to treat some cancers including Hodgkin lymphoma and germ cell tumours).\n* Participants with contraindications to gadolinium-based contrast agent",true,{"count":7,"type":21},[55],"NA","High-grade gliomas (HGGs) are the most common type of brain cancer in adults. Life expectancy for patients with HGGs is low. Radiotherapy aims to cure the tumour, but this is hard because HGGs are resistant to treatment. Among the possible causes of resistance may be tumour cells with low-oxygen levels (hypoxia). The investigators know that hypoxia reduces tumour sensitivity to radiotherapy. Using a special imaging technique called oxygen-enhanced MRI (OE-MRI), the investigators can try to identify areas of the tumour with hypoxia. The investigators could then give those areas a higher dose of radiotherapy. This might improve tumour control. This study aims to see if OE-MRI can find low-oxygen areas in HGGs. The study will also assess whether higher radiotherapy doses can be simulated in these regions.\n\nProject summary:\n\n1. Set up the OE-MRI process at Leeds Cancer Centre (LCC). OE-MRI settings will be tested on healthy volunteer participants to ensure the images are as good as possible.\n2. Participant Imaging. Patient participants with HGG will be recruited to take part. OE-MRI will be used to image participants during their treatment and track low-oxygen areas before treatment, halfway through treatment and 3 months after treatment has finished.\n3. Dose Escalation Assessment. Computer programs will be used to design radiotherapy treatments to test if higher radiation doses to the tumour's low-oxygen areas can better control the cancer. This will help understand if this targeted approach has potential benefits. This is modelling and will not alter routine clinical patient participant management.",[58,59,27,60],"High Grade Gliomas","Hypoxia Brain","Brain Neoplasms, Adult",[62,63,64,65,66,67],"Oxygen-enhanced MRI","OE-MRI","Functional MRI","Hypoxia imaging","Quantitative MRI","Tumour hypoxia","NOT_YET_RECRUITING","2026-06-26",{"date":33,"type":36},{"date":72,"type":21},"2026-09-01",{"date":74,"type":21},"2028-10-31",{"name":76,"class":77},"The Leeds Teaching Hospitals NHS Trust","OTHER",{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"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":86,"type":21},162,[24],"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?",[27,90,91,92,93,94,95],"Newly Diagnosed Glioblastoma","GBM","Glioblastoma Multiforme (GBM)","Glioma","Central Nervous System Diseases","Brain Cancer",[97,98,99,100,101,102,103,104,105,106,107,108,109],"EGFR","Glioblastoma","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":112,"type":36},"2026-06-22",{"date":114,"type":36},"2026-05-05",{"date":116,"type":21},"2029-03",{"name":118,"class":43},"Black Diamond Therapeutics, Inc.",14,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100621851","music-therapy-in-newly-diagnosed-glioblastoma-after-chemoradiation-therapy-melody-gbm-100621851","NCT07375992","Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM)","Music Therapy in Newly Diagnosed Glioblastoma After Chemoradiation Therapy (MELODY-GBM) J2556","MELODY","Inclusion Criteria:\n\n* Glioblastoma (Newly Diagnosed)\n* Cognitive capacity to respond to surveys\n* Access to computer and web access\n* Ability to attend virtual music therapy sessions\n* Audibly process music\n* Proficient in English\n\nExclusion Criteria:\n\n* Not planning to undergo standard of care radiation therapy and concurrent and adjuvant temozolomide.\n* A life expectancy of less than 6 months.\n* Concurrent use of any other standard or investigational agents (excepting tumor treating fields).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness\u002Fsocial situations that would limit adherence with study requirements.",{"count":129,"type":21},35,[55],"The Brain Cancer Program, in partnership with the Center for Music and Medicine at Johns Hopkins, will study whether music therapy is feasible in newly diagnosed GBM patients undergoing standard care.",[27],[134,98,135],"newly diagnosed","Music Therapy","2026-06-17",{"date":110,"type":36},{"date":139,"type":36},"2026-05-26",{"date":141,"type":21},"2029-02-28",{"name":143,"class":77},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",1,{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100581473","the-feasibility-and-efficacy-of-dose-timing-morning-vs-evening-of-temozolomide-in-the-treatment-of-glioblastoma-100581473","NCT06850766","The Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma","A Randomized, Multicentre Pilot Trial Evaluating the Feasibility and Efficacy of Dose Timing (Morning vs Evening) of Temozolomide in the Treatment of Glioblastoma","TMZ-CHRONO","Inclusion Criteria:\n\n* 18 years of age or older\n* Newly diagnosed IDH-wildtype glioblastoma\n* Completed maximal safe brain tumor resection\n* Completed post-operative brain RT\n* Plan to proceed with up to 6 cycles of adjuvant TMZ within 8 weeks of completing post-operative RT\n* Able and willing to provide oral informed consent\n\nExclusion Criteria:\n\n* Unable or unwilling to complete study questionnaires\n* Metastatic or incurable cancer other than IDH-wild type glioblastoma",{"count":154,"type":21},50,[55],"The body's biological functions follow a circadian rhythm, meaning that individual biological functions in the body change over a 24-hour cycle. There is evidence suggesting that the body and cancer cells may react differently to anti-cancer treatment based on the time of day they are exposed. In fact, researchers have already found that giving anti-cancer treatments at a particular time of the day works better in rectal and ovarian cancer. Temozolomide (TMZ) is a chemotherapy pill\u002Fcapsule commonly given to patients with newly diagnosed glioblastoma after brain surgery and radiation treatment. However, there is no current standard for what time of day TMZ should be taken for the treatment of glioblastoma.\n\nIn the current study, participants are randomly placed in one of two groups: a morning group and an evening group. Based on this group placement, participants are instructed to either take their TMZ in the morning or in the evening and record the date and time they take their TMZ in a pill diary. Participants will wear a wrist actigraphy device for the first cycle of TMZ. The primary goal of the study is to understand if taking TMZ at a prescribed time of day (morning\u002Fevening) is feasible in adults with glioblastoma. This is a pilot trial, and the investigators hypothesize that it will be feasible for glioblastoma patients to take TMZ at the prescribed time of day. The secondary goals of this study are to evaluate participant recruitment, safety, health-related quality of life, biological timing of TMZ delivery, and changes in condition over time. This pilot study will help investigators plan for a larger, pragmatic randomized clinical trial in the future.",[158,27],"IDH-Wildtype Glioblastoma",[102,160,161,162,163,164,165],"chronotherapy","dose timing","cancer","oncology","glioblastoma","chemotherapy","2026-06-15",{"date":168,"type":36},"2026-06-16",{"date":170,"type":36},"2025-05-08",{"date":172,"type":21},"2031-11",{"name":174,"class":77},"Ottawa Hospital Research Institute",2,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":22,"phases":186,"briefSummary":188,"conditions":189,"keywords":193,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":175},"100642374","early-phase-1-dosimetry-safety-and-efficacy-study-of-177lulu-xt771-in-patients-with-recurrent-glioblastoma-100642374","NCT07648823","Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma","An Investigator-Initiated Trial to Evaluate the Dosimetry, Safety, Tolerability, and Preliminary Efficacy of a Single-Dose [177Lu]Lu-XT771 Injection in Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Subject has fully understood the study and voluntarily signed the informed consent form.\n2. Age ≥ 18 and ≤ 80 years old.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n4. Life expectancy of at least 3 months.\n5. Histologically confirmed glioblastoma (based on the 2021 WHO Classification of Tumors of the Central Nervous System, 5th edition), and confirmed CA IX\u002FCA XII positive by histology or \\[68Ga\\]Ga-XT771 PET\u002FCT.\n6. Histologically confirmed recurrence of glioblastoma following prior treatments.\n7. Suitable for Ommaya reservoir placement and meets the conditions for drug administration, as judged by the investigator.\n8. Tumor resection cavity volume between 2.5 and 25 cm\\^3.\n9. On a stable or decreasing dose of corticosteroids (≤5 mg\u002Fday of dexamethasone or equivalent) for at least 1 week prior to the first dose.\n10. Toxicity from prior anti-tumor treatments (e.g., chemotherapy, radiotherapy, immunotherapy) recovered to ≤ Grade 1 (excluding alopecia).\n11. Adequate organ and bone marrow function meeting the following criteria:\n\n    * Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 ×10\\^9\u002FL and white blood cell (WBC) count ≥ 3 ×10\\^9 \u002FL (without growth factor support within 28 days prior to dosing); Platelet count ≥ 75 ×10\\^9\u002FL; Hemoglobin ≥ 90 g\u002FL.\n    * Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 2.0 × ULN for subjects with liver metastases; ≤ 3.0 × ULN for subjects with confirmed Gilbert's syndrome); ALT and AST ≤ 3 × ULN (\\\u003C 5 × ULN for subjects with liver metastases); Albumin \\> 30 g\u002FL.\n    * Renal function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL\u002Fmin.\n    * Coagulation: INR ≤ 2.0, APTT ≤ 1.5 × ULN. (Exception: subjects receiving warfarin may have an INR between 2 and 3 inclusive).\n12. Fertile subjects (and their partners) must agree to use highly effective contraceptive methods (e.g., condoms, oral or injectable contraceptives) during the treatment period and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Received anti-tumor treatments (including radiotherapy, chemotherapy, biological therapy, endocrine therapy, targeted therapy, etc.) within 4 weeks prior to dosing. Exceptions: (1) immunotherapy, nitrosoureas, or mitomycin C within 6 weeks prior to dosing; (2) oral fluorouracils and small molecule targeted drugs within 2 weeks or 5 half-lives (whichever is longer) prior to dosing; (3) Traditional Chinese Medicine with anti-tumor indication within 2 weeks prior to dosing; (4) cranial radiotherapy within 3 months prior to dosing.\n2. Received any other unapproved investigational drug within 4 weeks prior to dosing.\n3. Underwent major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to dosing, or expected to require elective surgery during the study period.\n4. Known or suspected allergy to the study drug or its analogue components.\n5. Inability to undergo contrast-enhanced MRI scans (e.g., due to pacemakers, contrast agent allergy).\n6. Presence of active or uncontrolled infections requiring systemic intravenous treatment, or unexplained fever \\>38.5°C during the screening period or before dosing.\n7. Presence of severe coagulation disorders or evidence of significant bleeding risk; history of gastrointestinal bleeding; any Grade ≥2 bleeding event (CTCAE v5.0) within the past 6 months.\n8. Active Hepatitis B (HBsAg positive and HBV-DNA \\> 500 IU\u002FmL or above the lower limit of detection of the study center) or Active Hepatitis C (HCV antibody positive and HCV-RNA \\> the lower limit of detection of the study center).\n9. Uncontrolled hypertension as judged by the investigator (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg despite standard treatment).\n10. History of severe cardiovascular disease, such as ventricular arrhythmias requiring clinical intervention; QTc interval \\> 480 ms; acute coronary syndrome, congestive heart failure, stroke, or other ≥ Grade III cardiovascular events within 6 months prior to dosing; NYHA class II-IV or LVEF \\\u003C 50%.\n11. History of other uncured malignancies within the past 3 years or concurrently, except for curable in situ cancers (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin).\n12. Presence of two or more intracranial lesions, extracranial metastases, or tumors located in the infratentorial compartment or basal ganglia.\n13. Brain MRI indicating that the enhancing edge of the tumor invades the ventricular wall, or the surgical cavity communicates with the ventricle.\n14. Psychiatric disorders or poor compliance.\n15. Pregnant or lactating women.\n16. The investigator considers the subject unsuitable for participation in this clinical study due to other severe systemic diseases or other reasons.","80 Years",{"count":185,"type":21},5,[187],"EARLY_PHASE1","The primary objective of this study is to evaluate the dosimetry, safety, and tolerability of the investigational radiopharmaceutical \\[177Lu\\]Lu-XT771 in patients with recurrent glioblastoma, an aggressive form of brain cancer. \\[177Lu\\]Lu-XT771 is designed to specifically target and deliver beta radiation directly to tumor cells that overexpress carbonic anhydrase IX and XII (CA IX and CA XII).\n\nThis early-phase, investigator-initiated trial will enroll a small group of approximately 3-5 patients, each receiving a single dose of \\[177Lu\\]Lu-XT771. The drug will be administered locoregionally via an implanted Ommaya reservoir, directly into the tumor cavity. Following administration, patients will be closely monitored using single-photon emission computed tomography\u002Fcomputed tomography (SPECT\u002FCT) to assess the biodistribution of the drug and to quantify the absorbed radiation dose to both the tumor and normal organs.\n\nThe study will also document all adverse events to characterize the safety profile of the treatment and will provide a preliminary assessment of its anti-tumor activity, as measured by progression-free survival. The information gathered from this exploratory study will be used to determine the recommended safe starting dose for future Phase I clinical trials.",[190,191,27,192],"Recurrent Glioblastoma (WHO-Grade IV Glioma)","Recurrent Glioblastoma","Recurrent Glioblastoma IDH Wildtype",[191,194,195,196,197,198,199],"[177Lu]Lu-XT771","Carbonic Anhydrase IX","Carbonic Anhydrase XII","Safety and Tolerability","Dosimetry","Efficacy","2026-06-13",{"date":168,"type":36},{"date":203,"type":21},"2026-06-20",{"date":205,"type":21},"2028-06-01",{"name":207,"class":77},"Beijing Tiantan Hospital",{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":175},"100619555","phase-1-study-of-an-aav-mediated-dual-payload-gene-therapy-in-patients-with-high-grade-glioma-100619555","NCT07346144","Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","A Phase I\u002FII Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","ADePT","Inclusion Criteria:\n\n* Aged 18-70 years\n* Karnofsky performance status ≥70\n* Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI\n* Recurrent patients: First radiological progression (as determined by the multidisciplinary team \\[MDT\\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological\u002Fmolecular diagnosis of GBM\n* Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)\n* Debulking surgery is indicated for optimal patient care\n* Able to swallow oral medication\n* Willing to avoid live vaccines\n* Adequate organ function\n* Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0.\n* All patients must agree to practice true abstinence or to use highly effective contraception\n* Patient is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patient who is pregnant, lactating or planning pregnancy during the course of the study\n* Immunodeficiency or active auto-immune disease requiring systemic therapy.\n* Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery\n* Live vaccine within 28 days prior to Day 0\n* Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0\n* History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection\n* Received previous treatment with a gene therapy\n* Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment\n* Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted\n* Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007\n* Contraindication to MRI with gadolinium\n* Any condition expected to interfere with the intended timing of debulking surgery\n* Previous non-glioma cancer within 3 years (other than treated squamous\u002Fbasal cell skin cancer, treated early-stage cervical cancer or treated\u002Fbiochemically stable, organ confined prostate cancer)\n* Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study\n* Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product\n* Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the study\n* Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study\n\nNewly diagnosed patients only:\n\n* Any prior therapy for glioma\n* Intended use of tumour treating fields\n\nRecurrent patients only:\n\n* Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity\n* Intended use of tumour treating fields","70 Years",{"count":218,"type":21},68,[220,24],"PHASE1","The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma.\n\nTGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour.\n\nPatients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery.\n\nThe study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM.\n\nApproximately 68 people aged 18-70 will take part in the study.",[27,58,191,90],[98,30,224,225,226,227,228],"Gene Therapy","AAV","HSV-tk","IL-12","TGX-007","2026-06-11",{"date":231,"type":36},"2026-06-12",{"date":233,"type":36},"2026-04-21",{"date":235,"type":21},"2033-09",{"name":237,"class":43},"Trogenix ltd",{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":246,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":270,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":144},"100562786","phase-1-study-in-children-and-adolescents-of-177lu-dotatate-lutathera-combined-with-the-parp-inhibitor-olaparib-for-the-treatment-of-recurrent-or-relapsed-solid-tumours-expressing-somatostatin-receptor-sstr-luparped-100562786","NCT06607692","Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","Single-arm Open-label Phase I\u002FII Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).","LUPARPED","Inclusion criteria:\n\n* 18 months - 18 years of age at the time of the initial diagnosis.\n* ≥ 3 years at the moment of inclusion in the trial.\n* Diagnosis: relapsed\u002Frefractory solid tumours with positive uptake on SSTR-PET (PET-CT or PET-MRI), performed in the previous three months before entering the study.\n\nThe evaluation of SSTR expression will be classified according to a qualitative 4-point scale: SSTR expression V (visual score):\n\n* Score = 0: Below or equal to blood pool\n* Score = 1: Above blood pool and lower than liver\n* Score = 2: Equal to or above liver and lower than spleen\n* Score = 3: Equal to or above spleen\n\nPatients with scores ≥ 2 in the majority of the tumoral lesions will be considered to have a positive SSTR-PET and will be therefore eligible for the trial. Patients with a higher score are presumed to have a better response to the treatment.\n\nIt is admissible to have non-measurable disease only (e.g., HR-NB with bone-only or bone-marrow-only active disease).\n\n* Performance status ≥ 50% according to Lansky scale (\\\u003C16 years old) or Karnofsky scale (for ≥16 years old).\n* Life expectancy of at least 3 months.\n* Availability of ability to swallow tablets or capsules.\n* Adequate organ function within 28 days prior to enrolment, as defined by:\n\n  * Hb ≥10 g\u002Fdl (packed red blood transfusion is acceptable up to 24 hours prior starting treatment);\n  * White blood cell (WBC) count ≥ 2500\u002FμL (equivalent to 2.5 x 109\u002FL)\n  * Absolute Neutrophil Count (ANC) ≥ 1000\u002Fμl;\n  * Platelets ≥ 100.000\u002Fμl, without transfusion in the prior ≥7 days;\n  * Serum plasma creatinine ≤ 1.5 x upper limit of normal (ULN) OR estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (assessed by 2009-Schwartz formula).\n  * Total bilirubin ≤ 1.5 x the institutional ULN. For patients with known Gilbert's Syndrome ≤ 3.0 ULN is permitted.\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3.0 ULN.\n  * Albumin \\>3.0 g\u002FdL (3.0 g\u002FdL is equivalent to 30 g\u002FL)\n* A negative serum or urine pregnancy test in women with onset of menses or ≥12 years of age.\n* Patients of reproductive potential must agree to use highly effective contraceptive methods for the entire study duration and up to 7 months, in case of females, and 4 months in case of males, after the last dose of Lutathera, or up to 6 months, in case of females, and 3 months in case of males, after the last dose of olaparib, whichever takes places later.\n* Have the ability to comprehend and willingness to provide written informed consent (ICF) for the study before patient registration or any trial-related screening procedures. If the patient is \\\u003C18 years old, the written informed consent must be signed by the parent(s) or legal guardian(s) according to national regulations. In the case of patients between 12 and 17 years, they must sign an assent form, and if the patient turns 18 during their participation in the study, they must sign an informed consent form.\n* Adequate recovery from major surgery prior to receiving study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n\nExclusion criteria\n\n* Previous significant drug-induced hepatitis toxicity experienced in the past that has required treatment dose reductions, treatment discontinuation or that, at the investigator discretion, could infer a risk.\n* Having received more than one previous treatment with other radiolabelled somatostatin analogues.\n* Inability to swallow tablets or capsules.\n* Subjects who are currently receiving any other anticancer and\u002For investigational agents (e.g. chemotherapy, immunotherapy or biological therapy \\[including monoclonal antibodies\\]). There must be at least 28 days of washout from any prior treatment. In case of checkpoints inhibitors, there should be at least 4 months of washout. Palliative Radiation Therapy for symptom control (e.g. pain relief) could be acceptable, at the discretion of the investigator.\n* Treatment with long-acting somatostatin analogues within 28 days prior the administration of 177Lu-DOTATATE.\n* Known hypersensitivity to any of the excipients.\n* Subjects who have an uncontrolled infection.\n* Lactating women.","3 Years",{"count":7,"type":21},[220,24],"Study in children and adolescents of 177Lu DOTATATE (Lutathera®) combined with the PARP inhibitor olaparib for treatment of recurrent or relapsed solid tumours expressing somatostatin receptors (SSTR) (LuPARPed)",[251,252,253,58,254,255,256,257,258,259,98,27,260,261,262,263,264,265,266,267,268,269],"Solid Tumor Cancer","Medulloblastoma","High Risk Neuroblastoma","Meningioma","Paraganglioma","Pheochromocytoma","Neuroendocrine Tumours (NET)","Adrenal Tumours","DIPG","Osteosarcoma Recurrent","Carcinoma Adrenal","Synovial Sarcomas","Esthesioneuroblastoma","Neuroblastoma Recurrent","Solid Tumor Refractory to Conventional Treatment","Medulloblastoma Recurrent","Paraganglioma\u002F Phaeochromocytoma","Ependymoma","Ependymoma Recurrent",[271,272,273,274,275,276,277,278,279,280,281,282,283,259,284,285,286,287,288,289,290,291,292,268,293],"solid tumours","somatostatin receptors","SSTR","LUTETIUM","OLAPARIB","MEDULLOBLASTOMA","NEUROBLASTOMA","HIGH GRADE GLIOMA","MEININGIOMA","PARAGANGLIOMA","PHEOCHROMOCYTOMA","NEUROENDOCRINE TUMOURS","ADRENAL TUMOR","GLIOBLASTOMA","OSTEOSARCOMA","CARCINOMA ADRENAL","SYNOVIAL SARCOMA","ESTHESIONEUROBLASTOMA","RECURRENT","RELAPSED","RELAPSE","REFRACTORY","Ependimoma Recurrent","2026-06-02",{"date":296,"type":36},"2026-06-04",{"date":298,"type":36},"2024-09-20",{"date":300,"type":21},"2029-12",{"name":302,"class":77},"Fundación de investigación HM",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":144},"100638377","personalized-targeted-glioblastoma-therapies-by-ex-vivo-drug-screening-advanced-brain-tumor-therapy-clinical-trial-in-patients-scheduled-for-short-course-radiation-100638377","NCT07627334","Personalized Targeted Glioblastoma Therapies by ex Vivo Drug Screening: Advanced Brain Tumor TheRApy Clinical Trial In Patients Scheduled for shOrt Course radiatioN","ATTRACTION","Inclusion Criteria:\n\n* ECOG performance status 0-2\n* Newly diagnosed glioblastoma, IDH-wildtype - according to the 2021 WHO classification of Tumors of the Central Nervous System\n* Unmethylated MGMT promotor per local assessment\n* Successful PDC establishment and PDCs available for drug screening - based on inclusion in one of the following studies: (EK Nrs. (a) Medical University of Graz: 32-650 ex 19\u002F20; (b) Medical University of Vienna: 1407\u002F2021; (c) Karl Landsteiner University of Health Sciences: GS1-EK-4\u002F823-2022; (d) Kepler University Hospital Linz: 1323\u002F2022; (e) Medical University of Innsbruck 1003\u002F2023) and follow-up ethics covering the establishment of an Austrian GlioBank (EK Nrs. (a) Medical University of Graz: 36-253 ex 23\u002F24; (b) Medical University of Vienna: 2186\u002F2023; (c) Karl Landsteiner University of Health Sciences: GS3-EK-1\u002F211-2024; (d) Kepler University Hospital Linz: 1002\u002F2024; (e) Medical University of Innsbruck 1095\u002F2024)\n* Scheduled short-course radiotherapy with or without concomitant temozolomide\n* Written informed consent\n* No exclusion criteria\n\nExclusion Criteria:\n\n* Current participation in another therapeutic clinical trial.\n* Patients with a concurrent malignancy or malignancy within five years of study enrolment except for carcinoma in situ of the cervix, non-melanoma skin carcinoma or stage I uterine cancer within the last 3 years.\n* Pregnant or lactating women.\n* Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection are eligible. Patients positive for anti-HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥350 cells\u002Fmm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen). If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended.\n* Participants who are unable or unwilling to comply with the requirements of the protocol as assessed by the investigator.",{"count":311,"type":21},30,[55],"Patients will receive in addition to standard histology analysis also the PDC- based drug screening.",[27],"2026-05-31",{"date":296,"type":36},{"date":318,"type":21},"2026-06-01",{"date":320,"type":21},"2029-01-01",{"name":322,"class":77},"Medical University of Vienna",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":336,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":144},"100640405","litt-for-ultra-early-gbm-recurrence-100640405","NCT07616986","LITT for Ultra-early GBM Recurrence","Laser Interstitial Thermal Therapy for Ultra-Early, Pre-Radiotherapy Glioblastoma Recurrence","Inclusion Criteria:\n\n* Histologically confirmed glioblastoma, IDH-wildtype, regardless of MGMT status\n* ≥18 years of age\n* CRET\n* Karnofsky Performance Status (KPS) ≥70\n* No contra-indication for radio-chemotherapy\n* Scheduled for adjuvant radio-chemotherapy at University Hospital of Bern\n* Able to provide informed consent\n* No contra-indication for LITT\n* No pregnancy or active breast-feeding\n* No known coagulopathy independent of medication\n* No dissemination or multifocal disease\n* Patients lacking capacity to consent or considered vulnerable (e.g., minors, those under legal protection) are not included.\n\nExclusion Criteria:",{"count":331,"type":21},12,[55],"Glioblastoma (GBM) remains aggressive despite standard therapy (surgery (CRET) + RT\u002FCT). Over 40% of patients develop recurrence between surgery and pre-RT MRI, with median overall survival (OS) of 13.3m and 24.4m for patients with and without recurrence in pre-RT MRI, respectively. Reoperation is avoided as it delays adjuvant therapy.\n\nLITT offers a minimally invasive alternative that may:\n\n* Treat recurrence without delaying RT\u002FCT\n* Potentially sensitize tumors to subsequent therapy This study tests if LITT can be practically integrated within the critical 1-week window between pre-RT MRI and radiotherapy initiation, maintaining the adjuvant schedule.",[27,335],"Glioblastoma - Category",[337,338,339,340,341,342],"LITT","Laser Interstitial Thermal Therapy","ultra-early recurrence","GMB","GMB recurrence","GMB ultra-early recurrence","2026-05-28",{"date":318,"type":36},{"date":346,"type":36},"2026-02-06",{"date":348,"type":21},"2028-01-31",{"name":350,"class":77},"Insel Gruppe AG, University Hospital Bern",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":355,"acronym":356,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":369,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":144},"100638098","pire-20-a-stepped-care-model-for-involving-relatives-across-sectors-100638098","NCT07590726","PIRe 2.0: A Stepped-Care Model for Involving Relatives Across Sectors","PIRe","Inclusion Criteria\n\n* Primary relative of an adult diagnosed with acquired brain injury (ABI) or malignant brain tumor (MBT), admitted to a participating hospital department.\n* Formally identified as the primary relative by the patient.\n* Aged ≥18 years.\n* Ability to read, understand, and complete questionnaires in Danish.\n\nExclusion Criteria\n\n* Insufficient proficiency in Danish to complete questionnaires and participate in structured conversations.\n* Concurrent participation in another interventional study with a similar aim that may interfere with the present study.",{"count":359,"type":21},160,[55],"Serious brain diseases and injuries affect not only the person who becomes ill or injured, but also their family. Relatives of people with acquired brain injury (ABI) or malignant brain tumor (MBT) often take on a major role in daily care, decision-making, and coordination across healthcare services. This role can include managing information, supporting rehabilitation, and acting as a link between hospital care and community rehabilitation. Many relatives report high levels of stress, uncertainty, and emotional burden, especially during transitions between care settings.\n\nDespite recommendations for greater involvement of relatives, support for this group is often uneven and poorly coordinated across healthcare sectors. Relatives frequently experience lack of overview, limited guidance, and unclear expectations regarding their role. These challenges may increase caregiver burden and negatively affect both relatives' well-being and the continuity of care.\n\nThe PIRe 2.0 study aims to further test, and implement a structured intervention to support systematic involvement of relatives of people with ABI or MBT across hospital and community rehabilitation services. The intervention is designed as a \"caregiver compass\" that helps relatives understand their role, clarify their needs and wishes for involvement, and gain better overview of the care pathway.\n\nPIRe 2.0 is delivered through a stepped-care model, which allows the level of support to be adjusted over time based on each relative's level of burden and support needs. All relatives receive basic information and screening for caregiver burden using the 4-item Zarit Burden Interview (ZBI-4). Relatives who show signs of increased burden are offered additional support in steps, ranging from structured conversations with nurses to extended cross-sector coordination and specialized support for relatives with high or complex needs. Decisions about stepping up or down are based on both screening results and clinical assessment to ensure flexibility and person-centered care.\n\nThe study includes two groups of relatives: an intervention group receiving support through the PIRe stepped-care model, and a control group receiving usual care only. A total of 160 relatives will participate. Data are collected at baseline, at transitions between hospital and community care, and three to six months after the intervention.\n\nThe primary outcome is change in caregiver burden, measured with the Caregiver Burden Scale (CBS). Secondary outcomes include relatives' roles and responsibilities, perceived support and involvement in care, and mental well-being, assessed using validated patient-reported outcome measures.\n\nIn addition to evaluating the effect of the intervention, the study examines how the PIRe model can be implemented and sustained in everyday practice across healthcare sectors. The results are expected to show whether a structured, stepped-care approach can reduce caregiver burden, improve coordination between hospital and community services, and support more coherent and secure care pathways for people with ABI or malignant brain tumor and their relatives.",[363,364,365,366,367,27,368],"Brain Injuries, Acute","Brain Tumor Adult","Brain (Nervous System) Cancers","Traumatic Brain Injuries","Glioblastom WHO Grade 4","Stroke",[370,371,372,373,374,375,376,377,378,379],"Acquired brain injury","Malignant brain tumor","Relatives","Caregiver Burden","Involvement","Communication","Care transitions","Rehabilitation","Implementation","Stepped-care","2026-05-15",{"date":382,"type":36},"2026-05-19",{"date":384,"type":21},"2026-10-01",{"date":386,"type":21},"2029-09-30",{"name":388,"class":77},"Rigshospitalet, Denmark",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":399,"phases":4,"briefSummary":400,"conditions":401,"keywords":402,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":411,"leadSponsor":413,"locationsCount":415},"100624434","mental-health-and-suicidality-in-glioblastoma-patients-in-germany-100624434","NCT07409584","Mental Health and Suicidality in Glioblastoma Patients in Germany","Mental Health and Suicidality in Glioblastoma Patients in Germany - a Multicenter Observational Study (SHINE-GLIO Study)","SHINE-GLIO","Inclusion Criteria:\n\n* Diagnosis of glioblastoma, IDH wild-type (CNS WHO classification of 2021)\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Participants with clinically significant aphasia or language barrier as assessed by the investigator\n* History of other malignant tumors\n* Known tumor predisposition syndrome (e.g., Li-Fraumeni syndrome, Cowden syndrome, etc.)",{"count":398,"type":21},176,"OBSERVATIONAL","The aim of the study is to use standardized questionnaires to systematically record influencing factors or predictors for suicidal behavior in glioblastoma patients, particularly with regard to existing depression and anxiety symptoms.",[27],[164,403,404,405],"suicidality","depression","observational","2026-05-13",{"date":408,"type":36},"2026-05-18",{"date":410,"type":36},"2026-03-18",{"date":412,"type":21},"2027-12-01",{"name":414,"class":77},"University Hospital, Essen",6,{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":144},"100630236","early-phase-1-bgb-58067-in-newly-diagnosed-glioblastoma-patients-with-mtap-deleted-tumors-100630236","NCT07485049","BGB-58067 in Newly Diagnosed Glioblastoma Patients With MTAP-Deleted Tumors","A Phase 0\u002F2 Study of BGB-58067, an MTA Cooperative PRMT5 Inhibitor, in Newly Diagnosed Glioblastoma Patients With Methylthioadenosine Phosphorylase (MTAP) Deleted Tumors Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With Pharmacodynamic (PD)-Triggered Expansion Cohorts","Inclusion Criteria:\n\n* 1\\. Suspected newly diagnosed glioblastoma according to 2021 WHO criteria who have not received any tumor directed intervention other than biopsy.\n* 2\\. Has measurable disease (preoperatively), defined as at least one contrast-enhancing lesion with two perpendicular measurements of at least 1 cm.\n* 3\\. Age ≥ 18 at time of consent.\n* 4\\. Has a performance status of ≤ 2 on the ECOG scale.\n* 5\\. Has adequate bone marrow and organ function as defined by the following laboratory values (as assessed by the local laboratory for eligibility):\n\n  1. Adequate Bone Marrow Function Absolute neutrophil count ≥ 1500\u002FμL (≥ 1.5 x 109\u002FL) Platelets (at time of surgery) ≥ 100,000\u002FμL (≥ 100 x 109\u002FL) Hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL (Criteria must be met without erythropoietin dependency and without pRBC transfusion within prior 2 weeks.)\n  2. Adequate Hepatic Function Total Bilirubin ≤ 1.5x ULN (Participants with Gilbert's syndrome with a total bilirubin ≤ 3x ULN and direct bilirubin ≤ 1.5x ULN will be permitted.) AST (SGOT) ≤ 2.5x institutional ULN (Participants with liver metastases with ALT \\\u003C 5x ULN will be permitted) ALT (SGPT) ≤ 2.5x institutional ULN (Participants with liver metastases with ALT \\\u003C 5x ULN will be permitted.)\n  3. Adequate Renal Function eGFR ≥ 60 mL\u002Fmin\u002F1.73 m2 (Calculated as individualized eGFR using the CKD-EPI formula \\[2021\\]) If measured or calculated GFR (e.g., creatinine clearance; mGFR) is required or used: ≥ 60 mL\u002Fmin\n  4. Adequate Metabolic Function Albumin ≥ 2.8 g\u002FdL\n  5. Adequate Coagulation INR or PT and aPTT ≤ 1.5x ULN\n* 6\\. For females of childbearing potential:\n\n  1. Must have a confirmed negative serum pregnancy test (β-hCG) before starting study treatment (within 24 hours of first dose of study treatment); in rare cases where hCG is suspected to be elevated in the absence of pregnancy (e.g., due to a tumor producing hCG), an ultrasound must be performed to rule out possible pregnancy.\n  2. Must use a highly effective method of contraception (with a failure rate of \\\u003C1% per year and low user dependency) for at least 28 days prior to treatment, and agree to use such a method during study participation and for an additional 6 months after final study drug administration.\n  3. Agrees not to breastfeed starting at screening, during study participation, and for 6 months after final study drug administration.\n  4. Agrees not to donate eggs (ova, oocytes) for the purpose of reproduction starting at screening, during study participation, and for 6 months after final study drug administration.\n* 7\\. For females of non-childbearing potential, is no longer of childbearing potential due to surgical, chemical, or natural menopause.\n* 8\\. For males:\n\n  1. Agrees not to donate sperm starting at screening, during study participation, and for 3 months after final study drug administration.\n  2. Abstains from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agrees to remain abstinent starting at screening, during study participation, and for 3 months after final study drug administration.\n\nOR Must use a male condom and their female partner must use an additional highly effective method of contraception (with a failure rate of \\\u003C1% per year and low user dependency) starting at screening, during study participation, and for 3 months after final study drug administration.\n\n* 9\\. Agrees to adhere to protocol defined Lifestyle Considerations throughout study duration.\n* 10\\. Able and willing to comply with scheduled visits, treatment plans, laboratory tests and other procedures.\n* 11\\. Understands the informed consent document and has voluntarily agreed to participate by giving written informed consent (personally or via legally authorized representative(s), and assent if applicable). Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.\n\nExclusion Criteria:\n\n* 1\\. Unable to undergo MRI of the brain with intravenous (IV) contrast.\n* 2\\. Has a known active systemic bacterial infection (on IV antibiotics or has fever \\> 38.5°C at time of initiating study treatment) or fungal infection, or has a detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[e.g., hepatitis B surface antigen positive\\]). NOTE: Screening of viral infection is not required for enrollment.\n* 3\\. Has cardiovascular abnormalities including:\n\n  1. LVEF \\\u003C 50%\n  2. History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \\> 480 msec, except for right bundle branch block.\n  3. Uncontrolled\u002Fsymptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following: cardiac angioplasty or stenting, unstable angina pectoris, myocardial infarction, stroke\u002Ftransient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III or IV congestive heart failure, pericarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).\n* 4\\. Has symptomatic or radiographic leptomeningeal disease.\n* 5\\. Has other known concurrent severe psychiatric and\u002For uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risks, contraindicate participation in the clinical study, or compromise compliance with the protocol.\n* 6\\. Has received prior treatment with another investigational drug or other intervention within 5 half lives of the investigational product, whichever is longer.\n* 7\\. Has received prior treatment with another PRMT5 inhibitor.\n* 8\\. Has known allergic reactions to components of BGB-58067.\n* 9\\. Patients who require ongoing treatment with a strong CYP3A or CYP2C8 inhibitor or inducer, ≤ 5 half-lives or ≤ 14 days, whichever is shorter or known. Consider using alternative medications, per Investigator judgment.\n* 10\\. Has received a live\u002Fattenuated vaccine within 30 days of anticipated first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted.\n* 11\\. Is pregnant or breastfeeding.",{"count":424,"type":21},78,[187],"This is an open-label, multi-center, Phase 0\u002F2 trial designed to enroll up to 78 total participants with suspected newly diagnosed glioblastoma (nGBM) who are scheduled for surgical resection to accrue at least 14 participants in Arm A and 10 participants in Arm B. The trial will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of BGB-58067.\n\nThe study is composed of a Phase 0 and expansion Phase 2 component. The Phase 0 primary endpoint will be suppression of symmetric dimethylarginine (SDMA) in tumor tissue measured by immunohistochemistry (IHC). The Phase 2 primary endpoint will be 12-month overall survival rate (OS12).\n\nThe Phase 0 secondary endpoint will be to characterize the PK of BGB-58067 in tumor tissue, plasma, and cerebrospinal fluid (CSF). The Phase 2 secondary endpoints will include assessing the safety profile of BGB-58067 and evaluating clinical efficacy of BGB 58067 using overall survival (OS) and the 6-month progression-free survival rate (PFS6) estimated by Kaplan-Meier (K-M) methods.",[27],[429,430,431,432,433,434,90,435],"MTAP-Deleted","MGMT Methylation","Methylthioadenosine Phosphorylase","O6-Methylguanine-DNA Methyltransferase","PRMT5 Inhibitor","PRMT5i","Newly Diagnosed Grade 4 Glioma","2026-05-11",{"date":438,"type":36},"2026-05-14",{"date":440,"type":36},"2026-05-07",{"date":442,"type":21},"2028-11",{"name":444,"class":77},"Nader Sanai",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":457,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":144},"100619389","phase-1-study-of-low-intensity-focused-ultrasound-in-combination-with-immunotherapy-in-newly-diagnosed-unmethylated-glioblastoma-100619389","NCT07343986","Study of Low-Intensity Focused Ultrasound in Combination With Immunotherapy in Newly Diagnosed Unmethylated Glioblastoma","Phase I Clinical Trial of Anti-CD3 × Anti-EGFR Bispecific-armed T Cells (EGFR BATs) and Low-Intensity Focused Ultrasound (LIFU) Blood-brain Barrier Opening in Patients With MGMT Unmethylated Glioblastoma (GBM)","BATs FUS","Inclusion Criteria:\n\n1. Newly diagnosed supratentorial glioblastoma or gliosarcoma IDH wildtype and MGMT unmethylated that express EGFR (score ≥ 1 by IHC)) and confirmed by UVA pathology review.\n2. Age ≥ 18 and ≤ 70 years at the time of signing informed consent.\n3. Karnofsky Performance Status (KPS) ≥ 70.\n4. Be willing and able to provide written informed consent for the trial.\n5. Females of childbearing potential, and males, must be willing to use an effective method of contraception.\n6. Maximal surgical debulking of the tumor was performed where residual contrast enhancement is 2 cm3 or less on immediate post-operative MRI. Intraoperative post-resection MRI is acceptable.\n7. Able to communicate during the LIFU BBB opening procedure.\n8. BBB opening target(s) must lie in non-eloquent area(s).\n9. The brain tumor to be treated must be in the treatment envelope of the NaviFUS system with a minimum distance of 30 mm from the inner skull table.\n10. Females of childbearing potential should have a negative serum pregnancy test. Males who are partners of females of childbearing potential must agree to use an acceptable method of contraception throughout the study and for 1 month following completion of the EGFR BATs infusions.\n11. Demonstrate adequate organ function as defined in Table 1. All screening labs should be performed within 10 days before leukapheresis.\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of another malignancy within 2 years of being on-study. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, or any type of in situ cancer. Patients must not be on any treatment for another malignancy.\n2. Patients undergoing only biopsy (partial resection or greater is required).\n3. Patients with cerebellar or brainstem tumors.\n4. Patients with evidence of leptomeningeal dissemination or subependymal spread on initial MRI.\n5. Patients with extracranial metastases.\n6. Patients with evidence of acute intracranial hemorrhage.\n7. Known hypersensitivity to cetuximab or another EGFR antibody.\n8. Known sensitivity to gadolinium-based contrast agents.\n9. Known sensitivity to Lumason® ultrasound contrast agent.\n10. Alpha 1,3 Galactose IgE (\"alpha gal\") test result outside of the reference range (indicating likely hypersensitivity to cetuximab).\n11. Patients with claustrophobia.\n12. Clips, shunts, or other non-MRI compatible metallic implanted objects in the skull or the brain.\n13. Evidence of active bleeding or bleeding diathesis.\n14. Unable to discontinue use of anticoagulant therapy as per local standard.\n15. Scalp atrophy or scars in the expected location of the ultrasound transducer.\n16. Cardiac Status: Patients will be ineligible for treatment on this protocol if (before protocol entry):\n\n    * There is a history of a recent (within one year) myocardial infarction or stroke.\n    * There is a current or prior history of angina\u002Fcoronary symptoms requiring medications and\u002For a history of depressed left ventricular function (LVEF \\\u003C 45%).\n    * Patient has a pacemaker.\n17. There is clinical evidence of congestive heart failure requiring medical management.\n18. Has Human Immunodeficiency Virus (HIV) (HIV 1\u002F2 antibodies) or known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n19. Has received a live vaccine within 30 days of leukapheresis.\n20. Has received any treatment for GBM besides surgery.\n21. Females must not be pregnant or breastfeeding.\n22. Ongoing immunosuppressive therapy except for corticosteroids\n23. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n24. A patient may be excluded if, in the opinion of the treating investigator, the patient is not capable of being compliant.",{"count":331,"type":21},[220],"This is a phase 1 study for patients with newly diagnosed MGMT unmethylated IDH wild-type glioblastoma utilizing autologous activated T-cells armed with bispecific antibody (EGFR-BATs) that recognize the tumor. The investigators hypothesized that the combination of infusions of EGFR BATs and low-intensity focused ultrasound would induce blood-brain barrier opening and increase the permeability of the adoptive immunotherapy. The investigators will radiolabel the EGFR BATs with 89Zr-oxine for subsequent PET imaging to determine the trafficking and uptake of this approach. There is a concern that several infusions of EGFR BATs before BBB opening could change the immune tumor microenvironment that would not allow a permissive BBB after LIFU. Therefore, Arm A will have two LIFU with BBB opening after the 4th and the 8th infusion, and Arm B will have three LIFU with BBB opening after the 1st, 4th, and 8th infusions. This study will determine the safety and feasibility of the combination of low-intensity focused ultrasound (LIFU) with microbubbles BBB opening and EGFR BATs and the access of the adoptive cell immunotherapy to the tumor microenvironment to inform future studies.",[27],[458,99,459],"Focused Ultrasound","Immune Therapy",{"date":461,"type":36},"2026-05-06",{"date":463,"type":36},"2026-03-23",{"date":465,"type":21},"2028-12",{"name":467,"class":77},"University of Virginia",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":482,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":144},"100566028","phase-2-g-csf-after-chemo-radiation-in-patients-with-glioblastoma-100566028","NCT06649851","G-CSF After Chemo-radiation in Patients With Glioblastoma","A Phase 2 Randomized Open-Label Pilot Study of Granulocyte Colony Stimulating Factor (G-CSF) to Preserve Brain Structure and Function Following Standard Chemoradiation in Patients With Newly Diagnosed MGMT-Methylated Glioblastoma","Inclusion Criteria:\n\n* Participants must have confirmed newly diagnosed glioblastoma multiforme (GBM), World Health Organization (WHO) grade 4, IDH wildtype, either by histological or molecular criteria.\n* Molecular analysis needs to confirm a positive MGMT promoter methylation status using standard institutional testing methods.\n* Treatment needs to involve a planned 6-week course of standard of care radiation therapy with concurrent and adjuvant 6 monthly chemotherapy with temozolomide. Patients scheduled to receive an abbreviated radiation course (e.g., 3 weeks in elderly patients) are eligible.\n* Age ≥18 years. GBM is considered a biologically distinct disease in children. Children are excluded from this study but will be eligible for future pediatric clinical trials.\n* Karnofsky Performance Status (KPS) \\> 60, see Appendix A\n* No prior cranial irradiation.\n* No existing diagnosis of clinical dementia or high clinical suspicion for presence of any neurodegenerative disease (e.g., Alzheimer's Disease, Fronto-temporal Dementia (FTD), Parkinson's Disease, Motor Neuron Disease, etc.) prior to diagnosis of GBM.\n* Life expectancy of greater than 6 months.\n* Must be able to undergo repeated brain Magnetic resonance imaging (MRI) studies with administration of gadolinium (contrast enhanced brain MRI).\n* Participants must have adequate organ and bone marrow function (as defined below) to be able to receive standard chemoradiation therapy:\n\n  * leukocytes ≥2,500\u002FmcL\n  * absolute neutrophil count≥1,500\u002FmcL\n  * platelets ≥100,000\u002FmcL\n  * total bilirubin≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT)≤3 × institutional ULN creatinine≤ institutional ULN OR\n  * glomerular filtration rate (GFR) ≥60 mL\u002Fmin\u002F1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73 m2.\n\nFor patients with Gilbert's syndrome, total bilirubin can be ≤ 3xULN.\n\n* For participants with evidence of chronic hepatitis B virus (HBV) infection by history, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (use of granulocyte colony stimulating factor (G-CSF)) are eligible for this trial.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to G-CSF (Filgrastim associated allergic reactions).\n* Participants with uncontrolled intercurrent illness that could influence leukocyte counts, such as severe infection requiring intravenous antibiotics, or known HIV (human immunodeficiency virus), since HIV\u002FAIDS is an immunocompromising disease affecting lymphocyte counts (one of the correlative biomarkers in this study)\n* Pregnant women are excluded from this study because of the use of cytotoxic chemotherapy (temozolomide) and radiation, given as part of standard of care in this trial, is of teratogenic potential or has abortifacient effects. Because there is a risk for adverse events in nursing infants secondary to treatment of the mother with cytotoxic chemotherapy, breastfeeding should be discontinued if the mother is treated with cytotoxic chemotherapy.\n* Participants must be able to undergo repeated neurocognitive testing in English (or Spanish). As cognitive outcome is one of the main secondary endpoints of this study, the lack of normative and comparison data for non-English or non-Spanish-speaking patients would confound this outcome in our small sample size (see Statistical Analysis Plan for more details). Presence of significant aphasia or any other language impairment at time of diagnosis with GBM is considered an exclusion criterion. Any concerns or questions about a subject's ability to participate in neurocognitive testing can be directed to the study investigators for further discussion and clarification.\n* Participants with active thromboembolic event (pulmonary embolism or deep venous thrombosis) or prior thromboembolic event within 6 months prior to diagnosis of GBM may need to be excluded because of possible risks of thromboembolism with the use of G-CSF and will require further discussion with the PI prior to enrollment on a case-by-case basis.\n* Participants with the following medical conditions are excluded and not eligible based on elevated risk of G-CSF associated toxicity: Sickle cell disease or sickle cell trait, congenital neutropenia, hematological malignancy (leukemia or myelodysplastic syndrome).\n* Patients who are dependent on high doses of corticosteroids equivalent to 8mg of daily dexamethasone or more, or who are expected to be unable to taper steroids post-operatively to a dose of 4mg of dexamethasone or less prior to start of chemo-RT.",{"count":476,"type":21},60,[24],"This research study involves the study of granulocyte colony stimulating factor (G-CSF) in patients with MGMT-methylated glioblastoma multiforme (GBM) that are undergoing standard chemoradiation. The study aims to evaluate G-CSF's effects on brain health and cognitive function.\n\nThe name of the study drugs involved in this study are:\n\n* G-CSF (also called Filgrastim)\n* Temozolomide (TMZ), a standard of care chemotherapy drug",[480,27,481],"MGMT-Methylated Glioblastoma","Newly Diagnosed Glioblastoma Multiforme",[483,484,98,92],"MGMT-methylated glioblastoma multiforme (GBM)","Newly diagnosed MGMT-methylated glioblastoma multiforme (GBM)","2026-05-03",{"date":114,"type":36},{"date":488,"type":36},"2025-04-02",{"date":490,"type":21},"2030-01-31",{"name":492,"class":77},"Massachusetts General Hospital",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":508,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100635403","nk-cell-therapy-for-malignant-solid-brain-tumors-100635403","NCT07552233","NK Cell Therapy for Malignant Solid Brain Tumors","NK Cell Therapy for the Treatment of Malignant Solid Brain Tumors","Inclusion Criteria:\n\n1. Male or female, age 18-70 years old (both ends included)\n2. At least one evaluable lesion with previous biopsy or pathohistologic confirmation of malignant central nervous system tumor, with imaging suggestive of continued progression or recurrence after comprehensive treatment\n3. Karnofsky Performance Status (KPS) ≥ 60%\n4. Life expectancy \\> 4 weeks, and must be able to undergo an MRI with contrast\n5. Patients who completed radiotherapy or systemic therapies (including temozolomide\u002Fbevacizumab or other agents) for at least 4 weeks prior to enrollment. All prior treatment-related toxicities should be defined as ≤ grade 1 (except for toxicities such as alopecia or leukoplakia) according to the Common Terminology Standard for Adverse Events (CTCAE 6.0)\n6. Dexamethasone dose ≤ 4 mg\u002Fday or equivalent corticosteroid dose, or no dexamethasone administered\n7. Must have adequate organ and marrow function as defined below:\n\n   * White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL\n   * Absolute neutrophil count (ANC) \\> 1 x 10\\^9\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL\n   * Platelet (PLT) ≥ 80×10\\^9\u002FL\n   * Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C 1.5 × institutional upper limit of normal (ULN)\n   * Serum creatinine (Cr) \\\u003C 1.5 x institutional ULN\n   * Total bilirubin \\\u003C 1.5 x institutional ULN\n   * PT \\& PTT ≤ 1.25 x institutional ULN\n8. No obvious hereditary diseases\n9. Normal cardiac function with left ventricular ejection fraction \\>55%\n10. No bleeding and coagulation disorders\n11. Absence of positive blood cultures for bacteria, fungus, or virus within 48-hours prior to NK cell infusion and\u002For there aren't any indications of meningitis\n12. Fertile women must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception (hormonal or barrier method of birth control or abstinence) during the clinical trial and for 6 months after the last cell infusion; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately\n13. Signed, written informed consent\n\nExclusion Criteria:\n\n1. Active hepatitis B or C virus, HIV infection, or other untreated active infection\n2. Pregnant and lactating women\n3. Participants with organ failure\n4. Participants with a chronic disease requiring immunologic or hormonal therapy\n5. Participants with an allergy to immunotherapy and related cells\n6. Participants with uncontrolled intercurrent illness\n7. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n8. Participants with a history of organ transplantation or who are awaiting organ transplantation",{"count":501,"type":21},27,[55],"This is a multi-center, open-label investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and feasibility of combined intracranial and intravenous administration of ex vivo expanded and activated natural killer (NK) cells in adult patients with malignant solid brain tumors who have failed standard treatment modalities. The primary objective is to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of the combined NK cell therapy. Secondary objectives include preliminary assessment of anti-tumor activity as measured by progression-free survival (PFS), overall survival (OS), objective response rate (ORR) per RANO criteria, and evaluation of the immunological effects of NK cell infusion in the tumor microenvironment and peripheral blood.",[505,27,92,506,507],"Malignant Solid Brain Tumors","Brain Metastasis","Malignant Meningioma",[505,30,509,510],"Natural Killer Cell","NK Cell","2026-04-20",{"date":513,"type":36},"2026-04-27",{"date":515,"type":21},"2026-04",{"date":517,"type":21},"2030-12-31",{"name":519,"class":77},"Peking University Third Hospital",4,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":4},"100634975","phase-4-efficacy-of-zoster-vaccination-in-glioblastoma-patients-100634975","NCT07546669","Efficacy of Zoster Vaccination in Glioblastoma Patients","Herpes Zoster Vaccine and Autologous CMV-specific T Cells as an Immunomodulatory Adjunct to Standard Neurosurgical Resection Radiochemotherapy in Glioblastoma","STARGATE","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:\n\n* At least 18 years of age\n* Written informed consent of the subject\n* Life expectancy at least 3 months\n* Participants of child-bearing age must use effective contraception\n* Indication for definitive radiotherapy of glioblastoma or adjuvant radiation therapy of glioblastoma resection cavity according to interdisciplinary tumor board consensus and after radiation oncologists evaluation\n* Histopathologically proven glioblastoma\n* Incorporation of pre-neurochirurgical \u002F-treatment PET\u002FCT or\u002F and PET\u002FMRI findings into the radiation therapy plan if patient undergoes PET\u002FCT or\u002F and PET\u002FMRI\n\nExclusion Criteria:\n\nSubjects will not be included in the study if any of the following criteria apply. General Exclusion Criteria:\n\n* Subjects not able to give consent\n* Subject without legal capacity who is unable to understand the nature, scope, significance, and con- sequences of this clinical trial\n* Simultaneously participation in another clinical trial or participation in any clinical trial involving ad- ministration of an investigational medicinal product within 30 days prior to clinical trial beginning\n* Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk may confound the trial results or may interfere with the subject's participation in this clinical trial\n* Known or persistent abuse of medication, drugs or alcohol\n* Contraindications for radiotherapy (including active inflammatory disease)\n* Known hypersensitivity against vaccine contra herpes zoster, or its constituents\n* Gliomatosis cerebri at time of enrollment on any imaging or proved by histopathology\n* Synchronous secondary malignancy\n\nExclusion criteria regarding special restrictions for females as the treatment procedures require the highest degree of safety for the child:\n\n* Current or planned pregnancy or nursing women\n* Females of child-bearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep- tives, or intrauterine contraceptive devices) unless they are surgically sterilized \u002F hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases\n\nIndication-specific exclusion criteria in order to guarantee the highest degree of safety of all treatment procedures from a medical point of view:\n\n* Primary infra-tentorial located glioblastoma (justification: specific subgroup of patients with different prognosis)\n* Significant comorbidities at baseline, which would prevent possible chemotherapy, including:\n\n  i. Platelet count \\\u003C 100\u002Fnl ii. Absolute neutrophil count (ANC) \\\u003C 1.5\u002Fnl iii. AST or ALT \\> 3 times the upper limit of normal iv. Total bilirubin above the normal range v. Serum creatinine \\> 1.7 mg\u002Fdl\n* Patients with clinically significant liver-, renal- or blood disorder\n* Patients with known additional significant neurological disease (e.g. primary seizure disorder\\*, de-mentia, progressive degenerative neurological disease, meningitis or encephalitis, hydrocephalus with increased intracranial pressure)\n* Patients with brain tumor-related epilepsy, seizure-free under antiepileptic therapy are eligible\n* Active implanted medical device (e.g. deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts) or documented clinically signifi- cant arrhythmias\n* History of HIV infection",{"count":530,"type":21},230,[532],"PHASE4","In modern practice a trimodality treatment has emerged as standard of care for histologically confirmed glioblastoma.\n\nWe hypothesize that the additional vaccination against herpes zoster, after surgical resection followed by irradiation therapy and chemotherapy of patients with glioblastoma will lead to a superior local control, overall and progression free survival. In an additional experimental setting based on patient preference the immunological effectiveness of the adoptive transfer of autologous polyclonal cytomegalovirus (CMV) specific T cells will be examined.",[27],"2026-04-16",{"date":537,"type":36},"2026-04-23",{"date":539,"type":21},"2027-01-02",{"date":517,"type":21},{"name":414,"class":77},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":553,"conditions":554,"keywords":559,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":520},"100600687","phase-3-study-of-tlx101-tx-plus-standard-of-care-soc-versus-soc-alone-for-the-treatment-of-patients-with-recurrent-glioblastoma-100600687","NCT07100730","Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma","A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])","IPAX BrIGHT","Inclusion Criteria:\n\n1. Previously confirmed neuropathological diagnosis of glioblastoma, IDH-wildtype according to the WHO 2021 classification.\n2. Radiographic evidence of first recurrence or progressive glioblastoma according to RANO 2.0 criteria after first-line treatment with biopsy or maximal safe resection and standard radiotherapy or chemoradiotherapy having occurred at least 3 months after the end of prior radiotherapy. Prior first-line therapy may include a combination of:\n\n   1. Any systemic antineoplastic treatment other than nitroureas\n   2. Tumor-treating fields\n   3. Conventionally fractionated or abbreviated (minimum 15 fractions) radiotherapy\n3. Increased \\[18F\\]\\]FET PET tracer uptake inside or in the vicinity of tumor. Specifically, amino acid-based molecular imaging using \\[18F\\]FET PET will be evaluated following co-registration with MRI. The allocated physician\u002Freader will assess whether the observed pathologically increased amino acid uptake is located within the tumor or in the vicinity. This determination will serve as a guidance to confirm whether the uptake is tumor-associated. The uptake must be clearly discernible from background activity and measurable per PET RANO 1.0 criteria, as determined by central review.\n4. Tumor debulking for recurrent, progressive disease is allowed. The patient must have post-surgical (4-6 weeks) radiographic evidence for residual tumor according to RANO 2.0 with increased \\[18F\\] FET PET uptake and measurable disease according to PET RANO 1.0.\n5. 18 years or older\n6. Have the capacity to understand the study and be willing to comply with all protocol requirements.\n7. Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 or KPS≥70\n8. Patients on stable, not increasing dose of steroids in the previous 7 days can be included in the study\n9. Adequate hematological, liver and renal function at the time of screening.\n10. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of investigational drug product; must not be breast-feeding; and must agree to use a highly effective method of contraception during treatment and for 6 months following last dose of investigational product.\n11. Male patients must agree to use condoms during sex during the treatment period and for 3 months after the last dose of the investigational drug product and must not make semen donations during treatment and for 6 months following last dose of investigational drug product. For male patients with female partners of childbearing potential, females must agree to use a highly effective method of contraception during the treatment period and for 6 months following last dose of investigational drug product.\n\nExclusion Criteria:\n\n1. Prior course with external beam radiation to the brain in the past 3 months. Prior treatment with brachytherapy in the brain.\n2. Treatment with bevacizumab within the prior 6 weeks.\n3. Known contraindication to imaging tracer or any product of contrast media and MRI contraindications including implanted medical devices. Unable to lie still for at least 20 min or the duration of the MRI and PET imaging or the need for general anesthesia as part of the imaging procedure.\n4. History or evidence of delayed-type hypersensitivity-dependent chronic infection (ie, tuberculosis, systemic fungal or parasitic infection).\n5. Radiographic progression based on RANO 2.0 associated with clinical deterioration and life expectancy less than 3 months.\n6. Hemostaseologic conditions, precluding catheterization or invasive procedures.\n7. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product.\n8. Known liver or kidney disease, such as hepatitis, cirrhosis, renal failure.\n9. Severe chronic or active infections (including active tuberculosis, hepatitis B virus, or hepatitis C virus infection) requiring systemic therapy.\n10. Ongoing toxicity \\> Grade 2 NCI-CTCAE (version 5.0) from previous standard or investigational therapies.\n11. Administration of another investigational product within 90 days prior to screening.\n12. Expected non-compliance with longer-term admission at isolated nuclear medicine ward per regional regulations.\n13. Inability to complete the needed investigational and standard imaging examinations due to any reason (ie, severe claustrophobia, inability to lie still for the entire imaging time).\n14. Patients with known phenylketonuria.\n15. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the study investigator, would make the patient inappropriate for entry into the study.",{"count":154,"type":21},[552],"PHASE3","This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.",[555,98,27,556,557,558],"Neoplastic Disease","Glioblastoma Multiform","Glioblastoma Multiforme, Adult","Glioblastoma Multiforme (GBM) WHO Grade IV",[560,561,562,563,564,565,98,91,566,567,568,569,570,571],"Lomustine","Radiation Therapy","Radiopharmaceuticals","Positron-Emission Tomography","Brain Neoplasms","Glioblastoma Multiforme","Neoplasm Recurrence, Local","Central Nervous System Neoplasms","Brain cancer","Recurrent brain tumor","Brain tumor recurrence","LAT-1 targeted therapy","2026-04-15",{"date":535,"type":36},{"date":575,"type":36},"2025-11-02",{"date":577,"type":21},"2027-11",{"name":579,"class":43},"Telix Pharmaceuticals (Innovations) Pty Limited",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":593,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":610},"100607232","phase-1-a-phase-12-study-of-the-safety-and-tolerability-of-mt-125-in-gbm-patients-100607232","NCT07185880","A Phase 1\u002F2 Study of the Safety and Tolerability of MT-125 in GBM Patients","A Phase 1\u002F2 Single-Arm Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of MT-125 Monotherapy With Radiation in Newly Diagnosed Glioblastoma","STAR-GBM","Inclusion Criteria:\n\n1. Age ≥18 years at the time of signing the informed consent form (ICF).\n2. New Diagnosed with histologically or molecularly confirmed IDH wild type and MGMT unmethylated GBM.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2.\n4. The following laboratory values obtained ≤15 days prior to registration:\n\n   1. Hemoglobin ≥9.0 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥1500\u002Fmm3\n   3. Platelet count ≥100,000\u002Fmm3\n   4. Total bilirubin ≤1.5 x upper limit of normal (ULN)\n   5. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3 x ULN (or ≤5 x ULN for participants with liver involvement)\n   6. Prothrombin time (PT)\u002F International normalized ratio (INR)\u002F Activated partial thromboplastin time (aPTT) ≤1.5 x ULN OR if participant is receiving anticoagulant therapy and INR or aPTT is within target range of therapy\n   7. Serum eGFR ≥60 ml\u002Fmin\n5. QTc 470 ms on triplicate 12 lead ECG ≤29 days prior to registration. NOTE: QTc intervals will be corrected using Fridericia's formula (Fridericia 1920)\n6. Echocardiographic Assessment: Left Ventricular Ejection Fraction (LVEF) ≥ 55%.\n7. Negative serum pregnancy test done ≤7 days prior to first dose of MT-125 administration, for persons of childbearing potential only.\n\n   a. If \\>7 days between last test and first dose of study treatment, the serum pregnancy test will be repeated.\n8. Has provided written informed consent.\n9. Ability to complete questionnaire(s) by themselves or with assistance.\n10. Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).\n11. On a stable dose of steroids for at least 2 weeks prior to enrollment\n\nExclusion Criteria:\n\n1. Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n   1. Pregnant persons\n   2. Nursing persons\n   3. Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception.\n2. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.\n3. Receiving any other investigational agent.\n4. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.",{"count":589,"type":21},36,[220,24],"The purpose of the study is to determine the recommended dose and further understand the safety of MT-125 in participants who have been diagnosed with glioblastoma, a primary brain tumor, when administered in combination with your standard of care treatment.\n\nInitially, participants with newly diagnosed glioblastoma will be given different doses of MT-125 in combination with radiotherapy (RT) with the goal of identifying the highest tolerated dose.\n\nUp to 36 people with glioblastoma who are at least18 years old are being invited to join this study. MT-125 is a type of study treatment which acts on cancer cells in the brain to destroy them. It will be administered on the same day as your standard of care radiotherapy because it is also designed to help radiotherapy work better. However, this is the first time MT-125 will be studied in humans. Therefore, the use is considered investigational. If you would like more details about MT-125 in glioblastoma participants, please ask the Study Doctor.\n\nYou will be among the first participants with glioblastoma to receive this study treatment. Its safety and effectiveness have not yet been established in humans. Thus, we do not know whether it will work for you. Your condition may improve, may get worse, or there may be no change.\n\nThe selected participant population-individuals newly diagnosed with histologically and\u002For molecularly confirmed IDH wild-type, MGMT-unmethylated glioblastoma-represents those least likely to experience safety concerns or adverse events related to the study treatment, and most likely to derive therapeutic benefit.\n\nThere are certain tests\u002Fquestions you must complete to find out if you meet the requirements to be in the study. If you do not meet these requirements, you cannot take part in the study. If this happens, you can talk to your Study Doctor about other options.",[27],[98,594,595,596,597,134,598,91,599,600],"MGMT unmethylated GBM","IDH wild type","small molecule","MT-125","O6-methylguanine- DNA methyltransferase","isocitrate dehydrogenase (IDH) wild type","non-muscle myosin II","2026-04-09",{"date":603,"type":36},"2026-04-14",{"date":605,"type":36},"2026-04-01",{"date":607,"type":21},"2032-02",{"name":609,"class":43},"Myosin Therapeutics Inc.",3,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":619,"enrollmentInfo":620,"targetDuration":4,"studyType":22,"phases":622,"briefSummary":623,"conditions":624,"keywords":625,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":144},"100632287","phase-2-prophylactic-regimen-with-intrathecal-thiotepa-in-svz-positive-or-meningeal-risk-glioblastoma-100632287","NCT07511725","Prophylactic Regimen With Intrathecal Thiotepa in SVZ-positive or Meningeal-risk Glioblastoma","A Pilot Study of Prophylactic Intrathecal Thiotepa Plus the Stupp Regimen for Glioblastoma With Subventricular Zone Contact or Intraoperative Ventricular Entry（PRISM-Trial）","PRISM","Inclusion Criteria:\n\n* Age 18-75 years, either sex.\n* Histologically confirmed newly-diagnosed WHO grade IV glioblastoma with at least one measurable lesion on MRI.\n* Must fulfil ONE of the following high-risk imaging\u002Fsurgical conditions:\n\n  1. Pre-operative MRI showing tumour in direct contact with the lateral ventricular sub-ventricular zone (SVZ+); OR\n  2. Operative record and post-operative imaging documenting an intra-operative cerebro-spinal-fluid leak (ventricular entry, VE).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and estimated life expectancy ≥ 3 months.\n* Neurological symptoms stable for ≥ 7 days before enrollment.\n* Adequate bone-marrow reserve: neutrophils ≥ 1.5 × 10⁹\u002FL, haemoglobin ≥ 90 g\u002FL, platelets ≥ 75 × 10⁹\u002FL.\n* Coagulation acceptable: PT\u002FINR and aPTT ≤ 1.5 × upper limit of normal (ULN). Hepatic: total bilirubin ≤ 1.5 × ULN, ALT \\& AST ≤ 1.5 × ULN, albumin ≥ 30 g\u002FL. Renal: serum creatinine ≤ 2 × ULN and calculated or 24-h creatinine clearance ≥ 50 mL\u002Fmin.\n* Reliable contraception from first dose until 3 months after the last dose for both sexes.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Active infection requiring intravenous antibiotics within 7 days before study entry, or therapeutic anticoagulation with warfarin.\n* History of any other malignancy within the previous 5 years (except adequately treated basal-cell carcinoma of skin or cervical carcinoma in-situ).\n* Known HIV infection, AIDS, immunodeficiency syndromes, or active autoimmune disease needing systemic therapy.\n* Severe medical, neurological or psychiatric conditions that would preclude compliance with protocol procedures.\n* Disrupted ventricular drainage catheter or anatomical contraindication preventing safe lumbar puncture or Ommaya reservoir placement.\n* Uncontrolled chronic illnesses: diabetes, congestive heart failure (NYHA III\u002FIV), hepatic cirrhosis, chronic kidney disease stage ≥ 3b, etc.\n* Any condition judged by the investigator to increase the risks of intrathecal chemotherapy or to confound toxicity assessment.","75 Years",{"count":621,"type":21},38,[24],"The goal of this clinical trial is to test whether adding preventive intrathecal chemotherapy (thiotepa) to the standard Stupp regimen can lower the risk of leptomeningeal metastasis (LM) and extend survival in patients with newly diagnosed glioblastoma (GBM) whose tumors touch the sub-ventricular zone (SVZ+) or whose surgery accidentally opened the ventricle (VE). The main questions it aims to answer are:\n\nCan six weekly intrathecal injections of thiotepa (10 mg) given during chemoradiotherapy increase the chance of remaining free of LM at one year? Does the approach also prolong overall survival and progression-free survival compared with historical controls? Is the combination safe and well-tolerated in this high-risk population?\n\nParticipants will:\n\nReceive maximal safe tumor resection followed by standard radiotherapy (60 Gy\u002F30 fractions) plus daily temozolomide (75 mg\u002Fm²).\n\nBegin thiotepa injections (via lumbar puncture or Ommaya reservoir) within 1 week of starting radiotherapy, repeated every 7 days for 6 doses.\n\nContinue standard adjuvant temozolomide (150-200 mg\u002Fm² days 1-5\u002F28) for 6 cycles.\n\nUnderstand that all procedures, toxicities and survival will be tracked for 2 years, with MRI and clinical visits every 4-8 weeks.\n\nProvide CSF and blood samples for exploratory biomarkers that may predict response or resistance.",[27],[626,627,628,629],"Prophylactic Intrathecal chemotherapy","thiotepa","ventricular invasion","ventricular entry","2026-03-30",{"date":632,"type":36},"2026-04-06",{"date":634,"type":36},"2026-01-04",{"date":636,"type":21},"2029-01-04",{"name":638,"class":77},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":640,"slug":641,"hasResults":12,"nctId":642,"briefTitle":643,"officialTitle":644,"acronym":4,"eligibilityCriteria":645,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":183,"enrollmentInfo":646,"targetDuration":4,"studyType":22,"phases":647,"briefSummary":648,"conditions":649,"keywords":651,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":656,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":175},"100630521","local-targeted-therapy-with-alpha-emitter-225acac-dota-sp-tat-in-newly-diagnosed-glioma-who-g3-g4-100630521","NCT07488754","Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) In Newly Diagnosed Glioma (WHO G3-G4)","Medical Experiment - Assessment of Efficacy & Safety of Local, Targeted Therapy With Neuropeptide Labelled With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) as Supplementary Therapy Following Standard Treatment Of Glioma (WHO G3-G4)","Inclusion Criteria:\n\n* age 18-80;\n* histologically confirmed diffuse glioma (CNS WHO G3-G4);\n* after standard treatment with biopsy or resection, radiotherapy and\u002For chemotherapy;\n* no sign of progression or radiation necrosis;\n* functional state \\>70 according to Karnofsky's performance scale (KPS);\n* ability to give informed consent to participate in the study.\n\nExclusion Criteria:\n\n* low-grade glioma;\n* progression or recurrence defined as: deterioration of the patient's condition according to the Karnofsky Performance Scale, worsening of neurological function, progressive neurological deficit, need to initiate or increase corticosteroid dose by \\>50%, progression or recurrence assessed on MRI (RANO criteria);\n* radiation-induced necrosis secondary to radiotherapy; may occur within the first 3 months after radiotherapy (exception: a patient after resection of radiation necrosis - not earlier than 4 weeks post-surgery, after a follow-up MRI);\n* need for emergency surgery (e.g., acute increase in intracranial pressure);\n* significant postoperative complications, e.g., KPS \\\u003C 70, wound infection, cerebrospinal fluid leak;\n* leak into the ventricular system \\>10% during the catheter patency check;\n* open\u002Fventricle-connected resection cavity;\n* catheter obstruction;\n* estimated life expectancy under 3 months;\n* patients without preserved logical\u002Fverbal contact;\n* lack of cooperation from the patient;\n* inability to give informed, voluntary consent to participate in the study;\n* patients enrolled in another medical trial;\n* patients who received any other investigational drug within 1 month prior to the first dose;\n* prior treatment with \\[225Ac\\]Ac-DOTA-SP;\n* breastfeeding or pregnant women;\n* severe comorbid organ diseases that, in the Investigator's opinion, significantly increase the procedural risk.",{"count":129,"type":21},[55],"Brain tumors account for 1.35% of all cancers and cause 2.2% of cancer-related deaths. Gliomas are the most common type, comprising 40-90% of central nervous system tumors in different age groups. The incidence of malignant gliomas is approximately 0.5-2 per 100,000 people annually. Standard treatments include surgical resection, radiotherapy, and chemotherapy, yet overall survival remains low, typically 1-3 years post-diagnosis. The study highlights the pressing need for novel treatment strategies, particularly given the infiltrative nature of gliomas and the potential for targeted therapies using neuropeptides.The aim of this study is to assess the efficacy and safety of local targeted therapy with \\[225Ac\\]Ac-DOTA-SP in newly diagnosed glioblastoma following standard treatment.It is an interventional study without a control group, initiated by the researcher. Patients included are aged 18-80 with WHO G3-G4 glioma post-first-line treatment, not requiring immediate surgery and meeting specific MRI criteria.Patients will receive a maximum of six cycles of \\[225Ac\\]Ac-DOTA-SP, involving pre-treatment assessments, local administration of the agent after ensuring catheter patency, and continuous monitoring. Blood tests and neurological evaluations will be performed regularly.Outcome will be assessed by measuring overall survival (OS) and progression-free survival (PFS). The study anticipates improvements in both OS and PFS when compared to current treatments, contributing to critical insights into targeted alpha therapy's effectiveness in glioblastoma.Treatment with \\[225Ac\\]Ac-DOTA-SP previously indicated few significant side effects, primarily transient issues like seizures. Patients will be closely monitored throughout the study to identify any adverse effects promptly.The estimated study duration is three years, with biological material collected for histopathological and genetic analysis during surgical reoperation.Data will be anonymized to protect patient confidentiality, stored securely, and made available only for the scope of the study.Led by Prof. Przemysław Kunert, the research team includes multiple co-investigators from neurosurgery and nuclear medicine departments.",[98,650,27],"High-Grade Glioma (WHO III-IV)",[652,164,653,654,655],"alpha emitter","local therapy","225-Ac","high-grade glioma",{"date":632,"type":36},{"date":658,"type":36},"2025-10-01",{"date":660,"type":21},"2028-09",{"name":662,"class":77},"Medical University of Warsaw",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":667,"acronym":4,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":669,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":682,"locationsCount":4},"100626098","phase-1-a-phase-1b2a-study-to-evaluate-the-safety-pharmacokinetics-and-objective-response-of-star-001-lp-184-in-combination-with-spironolactone-in-supratentorial-glioblastoma-at-first-progression-100626098","NCT07431216","A Phase 1b\u002F2a Study to Evaluate the Safety, Pharmacokinetics, and Objective Response of STAR-001 (LP-184) in Combination With Spironolactone in Supratentorial Glioblastoma at First Progression","Inclusion Criteria:\n\n1. Histopathology confirmed supratentorial GBM at first recurrence including both IDHwt GBM and IDHm Grade 4 astrocytoma.\n2. Provision of archival tissue and in re-resected subjects, contemporaneous tissue.\n3. No more than one prior systemic treatment (temozolomide + involved field radiotherapy +\u002F- an experimental agent +\u002F- tumor treating fields device) in IDHwt GBM\n4. No more than one prior systemic therapy following diagnosis of IDHm Grade 4 astrocytoma\n5. Radiographically measurable disease that can be assessed per RANO 2.0.\n6. Subjects are ≥ 18 and \\\u003C 70 years old at the time of informed consent with a diagnosis of progressive or recurrent GBM by MRI findings.\n7. Up to 5 subjects in each Simon stage have a clinically indicated need for surgical intervention per institutional standard of care.\n8. Performance status must be ≥ 70% on the Karnofsky scale within 14 days prior to enrolment.\n9. Subjects on a stable or decreasing dose of systemic corticosteroid regimen (no increase for 7 days and dexamethasone dose or equivalent steroid dose \\\u003C 4 mg\u002Fday) prior to baseline screening MRI are allowed. Exception is for subjects undergoing planned tumor resection where the dexamethasone dose may be temporarily increased and subsequently tapered as clinically indicated.\n10. Subject has adequate organ function, defined as follows:\n\n    Note: Complete blood count should be obtained without transfusion or receipt of colony-stimulating factors in the 2 weeks before obtaining a sample.\n    1. absolute neutrophil count ≥1,000\u002FμL\n    2. platelets ≥100,000\u002FμL\n    3. haemoglobin ≥ 8 g\u002FdL\n    4. serum creatinine clearance ≥60 mL\u002Fmin\n    5. total bilirubin ≤1.5× ULN or direct bilirubin ≤1 × ULN (exceptions are granted for patients with Gilbert's syndrome)\n    6. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN\n    7. international normalised ratio or prothrombin time (PT) ≤1.5 × ULN unless the participant is receiving anticoagulant therapy (PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants).\n    8. activated PTT ≤1.5 × ULN unless the participant is receiving anticoagulant therapy, if the PT or PTT is within therapeutic range of intended use of anticoagulants.\n11. A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    a. Is not a woman of childbearing potential (WOCBP). OR b. Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency, from the Screening Visit through at least 180 days after the last dose of study drug and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. Further guidance is provided in Appendix 5. Contraceptive and Barrier Guidance. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) within 72 hours before the first dose of study drug.\n\n    The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n12. A male subject of reproductive potential is eligible to participate if he agrees to the following starting with the first dose of study drug through at least 90 days (a spermatogenesis cycle) after the last dose of study drug:\n\n    1. refrain from donating sperm.\n\n       PLUS, either:\n    2. be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.\n\n    OR c. must agree to use a male condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a WOCBP who is not currently pregnant.\n13. The Investigator, or a person designated by the Investigator, will obtain written informed consent from each study participant or the participant's legally acceptable representative, when applicable, before any study-specific activity is performed. The Investigator will retain the original copy of each participant's signed consent document.\n14. Subject must provide archival tumor tissue sample at screening for retrospective exploratory biomarker analysis (see Laboratory Manual for tumor requirements). Subjects undergoing re-resection must also provide contemporaneous tumor sample at screening as well.\n15. Patients have been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.\n\n    \\-\n\nExclusion Criteria:\n\n1. Any radiation therapy within 12 weeks prior to the first dose of study drug. unless the progression is clearly outside the radiation field (e.g., beyond the high-dose region or 80% isodose line) or there is pathologic confirmation of disease progression.\n2. Subject has received more than 1 systemic therapy.\n3. Subject has known hypersensitivity to STAR-001 (LP-184) or spironolactone, their components, or their excipients.\n4. Subjects had a known additional malignancy that progressed or required active treatment within the last 2 years. Exceptions include treated basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.\n5. Subject is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease, or active infection that requires systemic therapy. Specific examples include, but are not limited to, history of (non-infectious) pneumonitis that required steroids or current pneumonitis, uncontrolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining consent).\n6. Subject has a condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the subject's participation for the full duration of the study treatment including the following:\n\n   a. Subjects who received colony-stimulating factors (e.g., granulocyte-colony stimulating factor, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 2 weeks prior to the first dose of study drug are not eligible.\n7. Subject has a known history of HIV (type 1 or 2 antibodies).\n8. Subject has known active hepatitis B (e.g., hepatitis B surface antigen reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \\[qualitative\\] is detected). Subjects with treated hepatitis C are permitted.\n9. Subject is currently participating and receiving an investigational agent.\n10. Subject has not recovered (i.e., to Grade ≤1 or to baseline) from cytotoxic therapy-induced adverse events (AEs). Note: Subjects with Grade ≤2 neuropathy, Grade ≤2 alopecia, or Grade ≤2 fatigue is an exception to this criterion and qualify for the study.\n11. Subject had treatment with prior systemic anticancer therapy within the 4 weeks prior to the first dose of study drug, or\n12. Subject has received a live vaccine within 14 days of planned start of study drug.\n13. Subject has clinically significant cardiovascular disease (e.g., significant cardiac conduction abnormalities, uncontrolled hypertension, cardiac arrhythmia or unstable angina, New York Heart Association Grade 2 or greater congestive heart failure, serious cardiac arrhythmia requiring medication, and history of cerebrovascular accident) within 3 months prior to screening.\n14. Subject has heart rate-corrected QT interval prolongation \\>480 ms (average of triplicate ECGs) by Fredericia at screening except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the medical monitor is required prior to enrolment.\n15. Patient is on medication that increases serum potassium (e.g., triamterene, propanolol or medications with labeled DDIs with spironolactone (e.g., digoxin).\n\n    \\-",{"count":218,"type":21},[220,24],"Approximately 58-68 total subjects will be enrolled. In the first stage, 10 response evaluable subjects (either IDHwt or IDHm Grade 4 astrocytoma) will be enrolled. If 1 or more of the first 10 response evaluable subjects achieve an objective response, 19 further subjects may be accrued in the second stage (for a total of 29 response evaluable subjects).\n\nSubjects enrolling in the study will provide fresh (in subjects who undergo a planned tumor resection) or archival (all subjects) tumor tissue sample (at least 10 unstained slides of 5-micron thickness) at screening for retrospective exploratory biomarker analysis and determination of intertumoral PTGR1 levels.\n\nSTAR-001 (LP-184) will be administered via IV infusion over 30 minutes on Day 1 and Day 8 of each 21-day cycle. The STAR-001 dose for this study is 0.39 mg\u002Fkg.\n\nSpironolactone will be administered orally on Day (-2), Day (-1), and between 4-8 hours before the STAR-001 infusion on D1 (Day of STAR-001 IV infusion) and on Day 6, Day 7, and between 4-8 hours before the STAR-001 infusion on Day 8 . The spironolactone dose for this study is 100 mg given 3 times prior to STAR-001 infusion.",[27],[674,675],"recurrent GBM","rGBM","2026-03-25",{"date":630,"type":36},{"date":679,"type":21},"2026-05-01",{"date":681,"type":21},"2027-05-01",{"name":683,"class":43},"Starlight Therapeutics Inc.",{"id":685,"slug":686,"hasResults":12,"nctId":687,"briefTitle":688,"officialTitle":689,"acronym":690,"eligibilityCriteria":691,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":216,"enrollmentInfo":692,"targetDuration":4,"studyType":22,"phases":694,"briefSummary":695,"conditions":696,"keywords":697,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":700,"lastUpdatePostDateStruct":701,"startDateStruct":702,"completionDateStruct":703,"leadSponsor":705,"locationsCount":4},"100630835","hypofractionated-radiotherapy-plus-temozolamide-in-patients-younger-than-70-years-with-glioblastoma-100630835","NCT07492836","Hypofractionated Radiotherapy Plus Temozolamide in Patients Younger Than 70 Years With Glioblastoma","Prospective, Pilot Study to Evaluate Hypofractionated Radiotherapy Associated With Temozolomide in Patients Aged 18 to 70 Years With Glioblastoma (HypoGBM)","HipoGBM","Inclusion Criteria:\n\n* Initial histological diagnosis of glioblastoma\n* Age \\> 18 and \\\u003C 70 years;\n* Karnofsky Performance Status \\> 70%;\n* Patient consent to participate in the study.\n\nExclusion Criteria:\n\n* Patients submitted to any type of previous radiotherapy in the cranial region;\n* Multicentric tumors;\n* Contraindication to chemotherapy with temozolomide;\n* Contraindications for performing magnetic resonance imaging (MRI), such as the use of implants or metallic prostheses;\n* Pregnant women or women of childbearing age who refuse to undergo the beta-HCG test before treatment and contraception during the intervention.",{"count":693,"type":21},10,[55],"The goal of this clinical trial is to evaluate the feasibility, safety and effectiveness of radiotherapy with fewer days of treatment and a higher dose of radiation each day in patients under 70 years of age diagnosed with a brain tumor known as glioblastoma.",[27],[698,699],"Radiotherapy","Temozolamide","2026-03-19",{"date":676,"type":36},{"date":515,"type":21},{"date":704,"type":21},"2029-04",{"name":706,"class":77},"Hospital do Coracao",{"id":708,"slug":709,"hasResults":12,"nctId":710,"briefTitle":711,"officialTitle":711,"acronym":712,"eligibilityCriteria":713,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":714,"enrollmentInfo":715,"targetDuration":4,"studyType":22,"phases":717,"briefSummary":718,"conditions":719,"keywords":720,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":722,"lastUpdatePostDateStruct":723,"startDateStruct":725,"completionDateStruct":726,"leadSponsor":728,"locationsCount":144},"100629262","impact-of-androgen-signaling-on-the-composition-of-the-immune-microenvironment-in-glioblastomas-100629262","NCT07472387","Impact of Androgen Signaling on the Composition of the Immune Microenvironment in Glioblastomas","Andro-iGlio","Inclusion Criteria:\n\n* Patients aged ≥18 and ≤55\n* Newly diagnosed GBM\n* Surgery with complete or incomplete resection\n* Eligible for chemoradiotherapy\n* No active immune disorders\n* Supratentorial location on MRI and no signs of meningeal dissemination\n* Tumor sample (taken as part of treatment) available for study (fresh frozen tissue)\n* Patient informed and consented to participate in the study\n* Affiliation with a social security system or beneficiary\n\nExclusion Criteria:\n\n* Active infection at the time of sampling or within the previous 14 days\n* Active immune disorders\n* Known patients with low-grade glioma that has undergone anaplastic transformation\n* Patients treated with corticosteroids\n* Patients participating in interventional research\n* Patients under legal protection, guardianship, or conservatorship.\n* Pregnant or breastfeeding women\n* Individuals under AME","55 Years",{"count":716,"type":21},40,[55],"Glioblastoma (GBM) is the most common and most aggressive primary brain cancer in adults. GBM is more common in men than in women, with a male-to-female ratio of 1.6. Furthermore, being male is associated with a poorer prognosis. These data suggest that sex and\u002For sexual hormones and more specifically androgens may play a role in the initiation, the growth, and the resistance to treatments of GBM.",[27],[98,721],"Androgen","2026-03-10",{"date":724,"type":36},"2026-03-16",{"date":605,"type":21},{"date":727,"type":21},"2030-04-01",{"name":729,"class":77},"Assistance Publique - Hôpitaux de Paris",{"id":731,"slug":732,"hasResults":12,"nctId":733,"briefTitle":734,"officialTitle":735,"acronym":736,"eligibilityCriteria":737,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":738,"targetDuration":4,"studyType":22,"phases":739,"briefSummary":740,"conditions":741,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":743,"lastUpdatePostDateStruct":744,"startDateStruct":746,"completionDateStruct":748,"leadSponsor":750,"locationsCount":144},"100628243","unity-based-mr-linac-guided-adaptive-radiotherapy-for-high-grade-glioma-4-100628243","NCT07459101","UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4","UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4 (UNITED-4): Prospective Evaluation of FLAIR-Guided Clinical Target Volume Reduction","UNITED-4","Inclusion Criteria:\n\n* Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma (IDH wild type or mutant)\n* Deemed clinically appropriate for concurrent chemoradiotherapy (with temozolomide) with definitive\u002Fradical intent\n* Biopsy or surgical resection performed ≤ 12 weeks prior to study entry\n* Expected survival ≥ 12 weeks\n* ECOG performance status of 0, 1 or 2\n* Sufficient estimated glomerular filtration rate (eGFR) of ≥ 30 mL\u002F min\u002F1.73 m2 to allow administration of gadolinium-based contrast agent; patients with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 not on dialysis may be allowed on the study after discussion of risks and benefits and approval by study neuroradiologist(s)\n* Completed written informed consent\n* Patient must be accessible for treatment and follow-up\n* Patients with multifocal or multicentric disease will be allowed per the discretion of the radiation oncologist\n\nExclusion Criteria:\n\n* Contraindications to MRI examination as per standard MRI screening policy\n* Contraindication to Gadolinium-based contrast media\n* Enhancing disease involving any part of the brainstem on post-gadolinium T1-weighted MRI imaging for patients being treated using the short-course 15-fraction regimen\n* Inability to lie flat in a supine position for at least 30 minutes\n* Inability to tolerate immobilization in a head thermoplastic mask\n* Patients \\> 140 kg and\u002For a circumference \\> 60 cm (MRI scanner weight and bore size limits)\n* Prior therapeutic cranial irradiation\n* Leptomeningeal dissemination of disease\n* History of other malignancies with the exception of adequately treated non-melanoma skin cancer, or curatively treated other solid tumours with no evidence of disease for ≥ 2 years\n* Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol",{"count":476,"type":21},[55],"This study builds on the results of prior studies (UNITED and UNITED-3). The goal of UNITED-4 is to test whether an adaptive radiation therapy (RT) therapy approach ('dose painting'), with reduced margins, impacts approach in participants with glioblastoma impacts local control compared to standard non-adaptive RT approach. The main questions of the study are to see how this adaptive RT approach with reduced margins compares to standard RT in terms of:\n\n* Local control\n* Overall and progression-free survival\n* Patterns of failure\n* Toxicity, Neurological Function, and Quality of Life\n* Longitudinal imaging features",[27,742],"Astrocytoma, Grade IV","2026-03-06",{"date":745,"type":36},"2026-03-09",{"date":747,"type":36},"2025-09-10",{"date":749,"type":21},"2030-10",{"name":751,"class":77},"Sunnybrook Health Sciences Centre"]