[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-multiforme-of-brain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-multiforme-of-brain":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,79,106,131,158,195,233,268,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100628690","phase-1-a-phase-1-safety-and-dose-finding-study-of-glix1-in-adults-with-recurrent-or-progressive-high-grade-glioma-100628690",false,"NCT07464925","A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","Main Inclusion Criteria:\n\n* Adult patients aged ≥18 years at the time of informed consent\n* Participants must have histologically confirmed Grade 3 or Grade 4 glioma\n* Recurrent or progressive disease\n* A maximum of two prior treatment lines\n* Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field.\n* Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:\n\n  * for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)\n  * for monoclonal antibodies: 42 days (6 weeks)\n  * for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)\n* Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n* Ability to swallow tablets or capsules.\n* Adequate hematological, liver and renal function.\n* Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index \\\u003C1%) for the duration of the study and for at least 3 months after the last dose of study medication.\n* Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.\n\nMain Exclusion Criteria:\n\n* Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI\n* Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and\u002For bisphosphonates or denosumab.\n* Participants with known active or uncontrolled infection, and\u002For unexplained fever \\>38°C in the 3 days prior to the start of study treatment.\n* Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent.\n* Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.\n\nPatients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.",[26,27,28],"Glioblastoma Multiforme of Brain","Glioma","Glioblastoma",[30,27,31,28,32],"GLIX1","GBM","TET2","RECRUITING","2026-06-07",{"date":36,"type":37},"2026-06-09","ACTUAL",{"date":39,"type":37},"2026-04-20",{"date":41,"type":20},"2027-12",{"name":43,"class":44},"Tetragon Biosciences Ltd","INDUSTRY",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100514481","omental-tissue-autograft-in-human-recurrent-glioblastoma-multiforme-rgbm-100514481","NCT05979064","Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)","Laparoscopically Harvested Omental Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of recurrent WHO Grade IV glioblastoma multiforme (GBM).\n2. Omental graft is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject intends to participate in another clinical trial.\n3. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject has had prior abdominal surgery that in the opinion of the general surgeon makes removal of omentum more risky or inadequate.\n10. Subject has severe renal insufficiency rendering gadolinium MRI contraindicated.\n11. Subject who are unable to have an MRI scan for any reason.",{"count":5,"type":20},[55],"NA","This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.",[27,58,28,59,26,31,60,61],"Glioma, Malignant","Glioblastoma Multiforme","Brain Cancer","High Grade Glioma",[63,64,65,66,67],"blood brain barrier","omentum autograft","omental autograft","omentum","omental","2026-05-28",{"date":70,"type":37},"2026-06-01",{"date":72,"type":37},"2023-04-04",{"date":74,"type":20},"2028-04",{"name":76,"class":77},"Northwell Health","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":78},"100578756","phase-1-gpc-3-car-t-cells-for-recurrent-gpc-3-positive-glioblastoma-100578756","NCT06815432","GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma","GPC-3 Chimeric Antigen Receptor T Cells FOR Recurrent GPC-3 Positive Glioblastoma","Procurement Inclusion Criteria:\n\n* Diagnosis of GPC3-positive recurrent glioblastoma with previous resection planned for repeat resection.\n* Age ≥18 years\n* Karnofsky score ≥60%\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent\n* GPC3 expression (as determined by immunohistochemistry) with an extent score of ≥ Grade 2 (\\>25% positive tumor cells) and an intensity score of ≥ 2 (scale 0-4).\n\nProcurement Exclusion Criteria:\n\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies).\n* History of organ transplantation\n* Known HIV positivity\n* Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections).\n* Exhibits other risk factors of which administration of investigational agent is deemed not in the patient's best interest, in the opinion of the investigator\n\nTreatment Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of recurrent glioblastoma with previous resection\n* Karnofsky score ≥ 60%-\n* Stable neurologic exam for 7 days prior to enrollment\n* Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg\u002Fkg dexamethasone or equivalent per day)\n* Adequate organ function:\n* Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml\u002Fmin\n* total bilirubin \\\u003C 3 times ULN for age\n* INR ≤1.7\n* absolute neutrophil count \\> 500\u002Fμl\n* platelet count \\> 100,000\u002Fμl (can be transfused but must be achieved prior to enrollment)\n* Hgb ≥ 7.0 g\u002Fdl (can be transfused)\n* Pulse oximetry \\>90% on room air\n* Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study\n* Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.\n* Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Exclusion Criteria:\n\n* Pregnancy or lactation\n* Uncontrolled infection\n* Known HIV positivity\n* Active bacterial, fungal or viral infection\n* History of organ transplantation\n* History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)","21 Years","70 Years",{"count":89,"type":20},27,[23],"The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells.\n\nAntibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T-cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat participants with cancers. They have shown promise, but have not been strong enough to cure most participants.\n\nThe study team has found from previous research that we can put a new gene (a tiny part of what makes-up DNA and carries the participants traits) into T cells that will make them recognize cancer cells and kill them. In the lab, the study team has made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33. The antibody GC33 recognizes a protein found on the participants brain tumor. This CAR is called GPC3-CAR. To make this CAR more effective, the study has also added a gene that includes IL15. IL15 is a protein that helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15. This study will test T cells with the IL15 GPC3-CAR (GO-CART T cells) in participants with GPC3-positive brain tumors.\n\nT cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. The study team will insert the iCasp9 and IL15 together into the T cells using a virus that has been made for this study. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. The study team will use this drug to kill the T cells if necessary due to side effects.\n\nThis study will test T cells genetically engineered with a GPC3-CAR and IL15 (GO-CART T cells) in participants with GPC3-positive brain tumors.\n\nThe GO-CART T cells are an investigational product not approved by the Food and Drug Administration.",[26],[94,95,28,96],"GPC3-positive tumors","GPC3-CAR T cells","Brain Tumor","2026-01-27",{"date":99,"type":37},"2026-01-28",{"date":101,"type":37},"2025-10-10",{"date":103,"type":20},"2044-12-03",{"name":105,"class":77},"Baylor College of Medicine",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":78},"100592259","phase-2-ruxolitinib-with-radiation-and-temozolomide-compared-to-radiation-and-temozolomide-for-newly-diagnosed-glioblastoma-100592259","NCT06991101","Ruxolitinib With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma","Randomized Phase 2 Trial of Ruxolitinib in Combination With Radiation and Temozolomide Compared to Radiation and Temozolomide for Newly Diagnosed Glioblastoma.","Inclusion Criteria:\n\n1. Provision of signed informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.\n4. Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated, unmethylated, or indeterminate MGMT.\n5. Confirmation that patient has sufficient tissue to undergo MGMT and IDH testing, as mandated.\n6. Must have a Karnofsky performance status (KPS) ≥ 70% (i.e., the patient must be able to care for themself with occasional help from others).\n7. Adequate organ (liver and renal) and bone marrow function within 14 days before randomization. For all parameters listed below, the most recent results available must be used:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3. Note: Granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 1 week prior to screening assessment.\n   2. Platelet count ≥ 100,000\u002Fmm3. Note: Platelet transfusion is not allowed within 1 week prior to registration.\n   3. Total bilirubin (TBL) ≤ 1.5 × institutional upper limit of normal (ULN).\n   4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n   5. Serum albumin ≥ 2.5 g\u002FdL.\n8. Patients able to become pregnant: use of highly effective contraception for at least one (1) month prior to screening and agreement to use such a method. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Such individuals must have a negative pregnancy test.\n9. Patients must have no concurrent malignancy except curatively treated early-stage bladder and prostate cancer that has been completed resected, basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ 3 years.\n\nExclusion Criteria:\n\n1. Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.\n2. Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).\n3. Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study.\n4. Patients who have had repeat craniotomy for tumor therapy after receiving radiation therapy and temozolomide treatment.\n5. Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment.\n6. Patient has previously taken ruxolitinib or is allergic to components of the study drug.\n7. Patients using warfarin.\n8. Uncontrolled immunodeficiency virus infection or active tuberculosis.\n9. Patients with active serious infections requiring systemic therapy.\n10. Known Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Participants with previous positive serology results must have negative polymerase chain reaction results.\n11. Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, New York Heart Association (NYHA) Grade ≥2 heart failure, uncontrolled hypertension, valvular disease, pericarditis, myocardial infarction, or other thrombosis events like including pulmonary embolism or deep vein thrombosis within 6 months of screening.\n12. Any other serious medical\u002Fpsychiatric condition, in the judgement of the investigator, that likely to interfere or limit compliance with study requirements\u002Ftreatment.",{"count":114,"type":20},190,[116],"PHASE2","The purpose of this research is to test the safety and effectiveness of the investigational drug ruxolitinib when it is combined with standard of care treatment (radiation therapy and temozolomide) for the treatment of newly diagnosed glioblastoma. Half the people in the study will be assigned to take the study drug ruxolitinib in addition to the standard of care temozolomide and radiation therapy and the other half will be assigned to the standard of care temozolomide and radiation therapy only. This assignment will be randomized in a 1-to-1 ratio, like the flip of a coin.",[28,60,59,26,119,120,121],"Glioblastoma Multiforme, Adult","MGMT-Unmethylated Glioblastoma","MGMT-Methylated Glioblastoma","2025-12-23",{"date":124,"type":37},"2025-12-26",{"date":126,"type":37},"2025-12-03",{"date":128,"type":20},"2030-12",{"name":130,"class":77},"Baptist Health South Florida",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":31,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":21,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100563259","early-phase-1-multitracer-18ffluciclovine-and-18f-fdg-pet-and-advanced-mri-for-metabolic-profiling-of-glioblastoma-100563259","NCT06613841","Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI for Metabolic Profiling of Glioblastoma","Pilot Study to Evaluate Multitracer [18F]Fluciclovine and 18F-FDG PET, and Advanced MRI Methods at 7Tesla Metabolic Profiling of Glioblastoma","Inclusion Criteria:\n\n* Participants will be ≥ 18 years of age\n\nMust meet the following criteria:\n\n-Diagnosis of a new intra-axial brain mass that is consistent with GBM per the opinion of a Penn neuroradiologist.\n\nOR\n\n* New contrast-enhancing lesion or lesions showing increased enhancement (\\>25%increase) in a patient with a historical diagnosis of glioblastoma (histologic or molecular proof) on standard MRI after completion of treatment\n* Recommended for clinically indicated surgical resection\n* Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.\n* Karnofsky performance status ≥ 60 per medical record review\n* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n* Females who are pregnant or breastfeeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of childbearing potential prior to injection.\n* Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study\n* Contraindications to MRI\n* Only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study",{"count":139,"type":20},15,[141],"EARLY_PHASE1","* To perform metabolic phenotyping of treatment naïve and recurrent GBM by multitracer \\[18F\\]Fluciclovine and 18F-FDG PET.\n* To compare uptake measures of 18F-Fluciclovine and 18F-FDG and MRI quantification of glutamate and lactate levels to tumor tissue laboratory assays (RNA seq and proteomics) of glutamine\u002Fglutamate, glucose, and lactate metabolism.\n* To perform metabolic phenotyping of treatment naïve and recurrent GBM by advanced MRI methods at 7 Tesla",[28,144,26],"Recurrent Glioblastoma",[146,147,28],"Early Phase 1","Cohort","2025-11-24",{"date":150,"type":37},"2025-11-28",{"date":152,"type":37},"2025-05-01",{"date":154,"type":20},"2026-12-31",{"name":156,"class":77},"Abramson Cancer Center at Penn Medicine",2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":175,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":78},"100606728","phase-1-focused-ultrasound-blood-brain-barrier-disruption-for-the-treatment-of-high-grade-glioma-in-patients-undergoing-standard-chemotherapy-100606728","NCT07179328","Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Assessment of Safety and Feasibility of Focused Ultrasound Next Generational Dome Helmet Mediated Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy","Inclusion Criteria:\n\n1. Age between 18 and 85 years, inclusive.\n2. Able and willing to provide written informed consent.\n3. Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.\n4. Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.\n5. Tumor or tumor resection cavity is clearly defined on screening MRI scans.\n6. Karnofsky Performance Score rating 70-100.\n7. American Society of Anesthesiologists (ASA) physical status score of 1-3.\n8. Life expectancy of at least 3 months and able to attend all study visits.\n\nExclusion Criteria:\n\n1. Patients presenting with the following imaging characteristics:\n\n   i. Following steroid treatment, brain edema and\u002For mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm.\n\n   ii. Evidence of recent (less than 2 weeks) intracranial hemorrhage. iii. Calcifications in the FUS sonication beam path in the event system tools cannot tailor the treatment around these calcification spots.\n2. The sonication pathway to the tumor involves:\n\n   i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.\n\n   ii. Clips or other metallic implanted objects in the skull or the brain, except shunts.\n3. The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).\n4. Patients requiring increasing doses of corticosteroids.\n5. Patient receiving bevacizumab (Avastin) therapy.\n6. Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative MRI. This cut-off is used to differentiate between pseudoprogression (which can occur following both radiation and TMZ therapy) and true tumor progression. This will be further ascertained through a discussion between the study neurosurgeons and radiologists.\n7. Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal irradiation with brachytherapy, stereotactic radiosurgery, and laser interstitial thermotherapy. These regimens have been shown to cause contrast enhancement in the resection cavity boundary, which can be difficult to differentiate from true tumor recurrence.\n8. Cardiac disease or unstable hemodynamics including:\n\n   i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv. Left ventricular ejection fraction \\\u003C50%. v. History of a hemodynamically unstable cardiac arrhythmia. vi. Cardiac pacemaker.\n9. Severe hypertension (diastolic blood pressure (DBP) \\> 100 on medication).\n10. Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor anticoagulants within 72 hours, or heparin-derived compounds within 48 hours of treatment).\n11. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.\n12. Abnormal level of platelets (\\\u003C 100,000) or INR \\> 1.3.\n13. Documented cerebral infarction within the past 12 months.\n14. TIA in the last 1 month.\n15. Cerebral or systemic vasculopathy.\n16. Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.\n17. Known sensitivity to gadolinium-DTPA.\n18. Known sensitivity to DEFINITY® ultrasound contrast agent or perflutren.\n19. Contraindications to MRI such as non-MRI-compatible implanted devices, unable to tolerate an MRI due to for instance pain or claustrophobia, untreated, uncontrolled sleep apnea.\n20. Positive pregnancy test (for pre-menopausal women).\n21. Known life-threatening systemic disease.\n22. Severely impaired renal function with estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 and\u002For on dialysis.\n23. Right to left or bi-directional cardiac shunt.\n24. Previous full course of chemotherapy for GBM (at the discretion of investigator).\n25. Previous radiotherapy.\n26. Allergy to eggs or egg products.\n27. Subjects with evidence of cranial or systemic infection.\n28. Subjects with chronic pulmonary disorders.\n29. Subjects with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular subjects with a history of anaphylaxis.\n30. Subjects with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation, or QT prolongation observed on screening ECG (QTc \\> 450 for men and \\>470 for women).\n31. Subjects with evidence of Hepatitis B virus infection\u002Fcarrier state.\n32. Liver injury as indicated by liver function tests that in the Investigator's opinion precludes participation in the study.","85 Years",{"count":5,"type":20},[23],"The goal of this clinical trial is to evaluate the safety and feasibility of focused ultrasound (FUS)-mediated blood-brain barrier (BBB) disruption using the Next Generation Dome Helmet (NGDH) in adults with glioblastoma (GBM) undergoing the maintenance phase of the standard \"Stupp protocol\".\n\nParticipants will:\n\n* Undergo repeated FUS BBB disruption treatments during the maintenance phase of temozolomide (TMZ) chemotherapy.\n* Receive intravenous ultrasound contrast (DEFINITY®) prior to each FUS session to facilitate targeted BBB disruption.\n* Undergo serial MRI scans and clinical assessments to evaluate safety and the extent of BBB opening.\n* Provide blood samples (and tumor tissue if available) for biomarker analysis related to BBB permeability, tumor presence, and treatment response.\n* Be followed for progression-free survival (PFS) and overall survival (OS) during routine neuro-oncology visits until end of life.",[31,170,26,171,172,27,173,174],"Glioblastoma Multiforme (GBM)","Glioblastoma Multiforme Glioma","HGG","Brain Tumor Adult","Brain Tumor, Primary",[176,177,31,178,179,180,181,182,183,184,185],"Focused Ultrasound","FUS","TMZ","Temozolomide","blood-brain barrier disruption (BBBD)","MR-guided Focused Ultrasound (MRgFUS)","Glioblastoma multiforme","blood-brain barrier opening","Drug delivery","Chemotherapy delivery","2025-09-10",{"date":188,"type":37},"2025-09-17",{"date":190,"type":37},"2025-06-04",{"date":192,"type":20},"2027-11",{"name":194,"class":77},"Sunnybrook Health Sciences Centre",{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":207,"conditions":208,"keywords":212,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100537907","the-recsur-study-resection-versus-best-oncological-treatment-for-recurrent-glioblastoma-encram-2302-100537907","NCT06283927","The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)","The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)","RECSUR","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. The tumor is suitable for resection (according to neurosurgeon)\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Medical reasons precluding MRI (e.g., pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Clinical data unavailable for the newly diagnosed setting","90 Years",{"count":205,"type":20},464,"OBSERVATIONAL","Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups.\n\nThis study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study has been approved by the Medical Ethics Committee (METC Zuid-West Holland\u002FErasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.",[28,59,209,26,119,144,210,211],"Glioblastoma, IDH-wildtype","Astrocytoma, Malignant","Astrocytoma of Brain",[28,213,214,215,216,217,218,219,220,221,222],"Radiotherapy","Chemotherapy","Re-resection","Resection","Overall survival","Progression-free survival","Neurological morbidity","Safety","Serious Adverse Events","Quality of life","2024-02-21",{"date":225,"type":37},"2024-02-28",{"date":227,"type":37},"2023-01-01",{"date":229,"type":20},"2028-01-01",{"name":231,"class":77},"Jasper Gerritsen",8,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":203,"enrollmentInfo":241,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":243,"conditions":244,"keywords":249,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":265,"leadSponsor":266,"locationsCount":232},"100537080","the-recmap-study-resection-with-or-without-intraoperative-mapping-for-recurrent-glioblastoma-100537080","NCT06273176","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma","The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2301)","RECMAP","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma\n3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)19\n4. The tumor is suitable for resection (according to neurosurgeon)\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem, or midline\n2. Multifocal contrast-enhancing lesions\n3. Medical reasons precluding MRI (e.g., pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Clinical data unavailable for the newly diagnosed setting",{"count":242,"type":20},225,"Resection of glioblastoma in or near functional brain tissue is challenging because of the proximity of important structures to the tumor site. To pursue maximal resection in a safe manner, mapping methods have been developed to test for motor and language function during the operation. Previous evidence suggests that these techniques are beneficial for maximum safe resection in newly diagnosed grade 2-4 astrocytoma, grade 2-3 oligodendroglioma, and recently, glioblastoma. However, their effects in recurrent glioblastoma are still poorly understood. The aim of this study, therefore, is to compare the effects of awake mapping and asleep mapping with no mapping in resections for recurrent glioblastoma.\n\nThis study is an international, multicenter, prospective 3-arm cohort study of observational nature. Recurrent glioblastoma patients will be operated with mapping or no mapping techniques with a 1:1 ratio. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months after surgery and 2) residual tumor volume of the contrast-enhancing and non-contrast-enhancing part as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) overall survival (OS), 2) progression-free survival (PFS), 4) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[209,28,26,210,245,246,247,248,144],"Brain Neoplasms","Brain Neoplasms, Adult, Malignant","Brain Neoplasms, Adult","Recurrent Adult Brain Tumor",[28,250,215,216,251,252,253,254,255,256,217,218,219,222,257,258,259,260],"Recurrent","Intraoperative mapping","Awake mapping","Awake craniotomy","Asleep mapping","Motor mapping","Language mapping","Functional area","Eloquent","Extent of resection","Residual tumor volume","2024-02-20",{"date":263,"type":37},"2024-02-22",{"date":227,"type":37},{"date":229,"type":20},{"name":267,"class":77},"Erasmus Medical Center",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":275,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":286,"leadSponsor":288,"locationsCount":232},"100527358","the-resbiop-study-resection-versus-biopsy-in-high-grade-glioma-patients-encram-2202-100527358","NCT06146725","The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)","RESBIOP","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Medical reasons precluding MRI (e.g. pacemaker)\n3. Inability to give written informed consent\n4. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n5. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin",{"count":276,"type":20},564,"There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.",[28,209,59,119,26],[216,280,281,222],"Biopsy","Survival","2023-11-18",{"date":284,"type":37},"2023-11-27",{"date":227,"type":37},{"date":287,"type":20},"2029-01-01",{"name":231,"class":77},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100351856","the-safe-trial-awake-craniotomy-versus-surgery-under-general-anesthesia-for-glioblastoma-patients-100351856","NCT03861299","The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.","The SAFE-Trial: Safe Surgery for Glioblastoma Multiforme: Awake Craniotomy Versus Surgery Under General Anesthesia. A Multicenter Prospective Randomised Controlled Study","SAFE","Inclusion Criteria:\n\n1. Age ≥18 years and ≤ 90 years\n2. Tumor diagnosed as Glioblastoma Multiforme on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumour necrosis as assessed by the surgeon\n3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya Grading II and II)\n4. The tumor is suitable for resection (according to neurosurgeon)\n5. Karnofsky performance scale 80 or more\n6. Written Informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brain stem or midline\n2. Multifocal contrast enhancing lesions\n3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation\n4. Medical reasons precluding MRI (eg, pacemaker)\n5. Inability to give consent because of or language barrier\n6. Psychiatric history\n7. Previous brain tumour surgery\n8. Previous low-grade glioma.\n9. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.\n10. Severe aphasia or dysphasia",{"count":298,"type":20},246,[55],"The trial is designed as a multicenter randomized controlled study. 246 patients with presumed Glioblastoma Multiforme in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according the eligibility criteria (see under). After written informed consent is obtained, the patient will be randomized for an awake craniotomy (AC) (+\u002F-123 patients) or craniotomy under general anesthesia (GA) (+\u002F-123 patients), with 1:1 allocation ratio. Under GA the amount of resection of the tumour has to be performed within safe margins as judged by the surgeon during surgery. The second group will be operated with an awake craniotomy procedure where the resection boundaries for motor or language functions will be identified by direct cortical and subcortical stimulation. After surgery, the diagnosis of GBM will have to be histologically confirmed. If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study. These patients will be followed-up according to standard practice. Thereafter, patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up. Total duration of the study is 5 years. Patient inclusion is expected to take 4 years. Follow-up is 1 year after surgery. Statistical analysis, cost benefit analysis and article writing will take 3 months.",[28,59,26,302,96,60,245],"Astrocytoma, Grade IV",[28,219,304,259,305,306,218,217],"Postoperative complications","Gross-total resection","Health-related quality of life",{"date":308,"type":37},"2023-11-21",{"date":310,"type":37},"2019-04-01",{"date":312,"type":20},"2027-09-01",{"name":231,"class":77},5]