[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glioblastoma-multiforme-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glioblastoma-multiforme-adult":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,44,75,95,135,172,200,224,249,282,311,348,378,401],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643886","ttfields-plus-fet-pet-guided-stereotactic-radiosurgery-versus-ttfields-alone-for-recurrent-glioblastoma-tarrget-20-100643886",false,"NCT07668869","TTFields Plus FET-PET-Guided Stereotactic Radiosurgery Versus TTFields Alone for Recurrent Glioblastoma (Tarrget 2.0)","Tumor Treating Fields (TTFields) Concomitant With Stereotactic Radiosurgery Based on FET-PET vs TTFields Alone for the Treatment of Recurrent, Glioblastoma (Tarrget 2.0)","Inclusion Criteria:\n\n* Age ≥18 years\n* Karnofsky Performance Status ≥70\n* Histologically confirmed IDH-wildtype glioblastoma\n* First, second, or third recurrence\n* Radiological recurrence according to RANO 2.0 criteria\n* Prior radiotherapy and temozolomide treatment\n* At least 6 months since completion of previous radiotherapy\n* Contrast-enhancing recurrent lesion visible on MRI\n* Maximum recurrent lesion diameter ≤5 cm\n* Available molecular profile including IDH and MGMT status\n* Adequate hematologic, renal, and hepatic function\n* Written informed consent\n\nExclusion Criteria:\n\n* Previous bevacizumab treatment\n* Planned chemotherapy or targeted therapy after study intervention\n* Previous stereotactic re-irradiation within the planned treatment field\n* More than three recurrences\n* Significant psychiatric disorders\n* Significant unrelated neurological disease\n* Implanted pacemaker, defibrillator, deep brain stimulator, or other incompatible electronic device\n* Pregnancy or breastfeeding\n* Active intracranial hemorrhage\n* Uncontrolled hypertension\n* Severe renal dysfunction\n* Participation in another interventional study likely to interfere with this study","ALL","18 Years",{"count":19,"type":20},92,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study evaluates whether the addition of FET-PET-guided stereotactic radiosurgery (SRS) to Tumor Treating Fields (TTFields) improves survival outcomes in patients with recurrent IDH-wildtype glioblastoma.\n\nPatients with recurrent glioblastoma have limited treatment options and poor prognosis. TTFields is a non-invasive antimitotic therapy that has demonstrated efficacy in recurrent glioblastoma. Stereotactic radiosurgery is commonly used in selected patients with recurrent disease; however, treatment efficacy may be limited by the infiltrative nature of glioblastoma and challenges in accurate target delineation.\n\nThe study hypothesizes that combining TTFields with FET-PET-guided stereotactic radiosurgery will improve one-year overall survival compared with TTFields alone. Participants will be randomized in a 1:1 ratio to receive either TTFields plus stereotactic radiosurgery or TTFields alone.",[26,27,28],"Glioblastoma","Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Glioblastoma Multiforme, Adult",[30],"glioblastoma, TTF, SRS, radiosurgery, stereotactic radiotherapy","RECRUITING","2026-06-19",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2025-12-30",{"date":39,"type":20},"2032-06",{"name":41,"class":42},"Prof. Franciszek Lukaszczyk Memorial Oncology Center","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100512623","surgical-tissue-flap-to-bypass-the-blood-brain-barrier-in-glioblastoma-100512623","NCT05954858","Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma","Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Glioblastoma Multiforme (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject is undergoing planned resection of known or suspected GBM.\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Based on the pre-operative evaluation by neurosurgeon, the subject is a candidate for ≥ 80% resection of enhancing region.\n6. Subject must be able to undergo MRI evaluation.\n7. Subject meets the following laboratory criteria:\n\n   1. White blood count ≥ 3,000\u002FμL\n   2. Absolute neutrophil count ≥ 1,500\u002FμL\n   3. Platelets ≥ 100,000\u002FμL\n   4. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed)\n   5. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN)\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN\n   7. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n8. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n9. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n10. Able to understand and willing to sign an institutional review board (IRB)- approved written informed consent document (legally authorized representative permitted).\n\nInclusion criteria considered during surgery:\n\n1. Subject has a histologically confirmed (frozen section) diagnosis of WHO Grade IV glioblastoma multiforme (GBM).\n2. TPFF and\u002For pericranial flap is technically feasible.\n\nExclusion Criteria:\n\n1. Subject, if female, is pregnant or is breast feeding.\n2. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n3. Subject intends to participate in another clinical trial\n4. Subject intends to undergo treatment with the Gliadel® wafer at the time of this surgery.\n5. Subject has an active infection requiring treatment.\n6. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n7. Subject has a history of other malignancy, unless the patient has been disease- free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n8. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n9. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.",{"count":52,"type":20},32,[23],"This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients.\n\nThe objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).",[56,26,57,28,58,59,60],"Glioma, Malignant","Glioblastoma Multiforme","High Grade Glioma","GBM","Brain Cancer",[62,63,64,65],"tissue autograft","blood brain barrier","pedicled temporoparietal fascial","pericranial flap","2026-05-28",{"date":68,"type":35},"2026-06-01",{"date":70,"type":35},"2023-06-29",{"date":72,"type":20},"2029-06-30",{"name":74,"class":42},"Northwell Health",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":43},"100460101","phase-3-repeated-superselective-intraarterial-cerebral-infusion-siaci-of-bevacizumab-with-temozolomide-and-radiation-compared-to-temozolomide-and-radiation-alone-in-newly-diagnosed-gbm-100460101","NCT05271240","Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed GBM","A Phase III Randomized Trial of Repeated Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (Avastin) With Temozolomide and Radiation Compared to Temozolomide and Radiation Alone in Newly Diagnosed Glioblastoma (GBM)","Inclusion Criteria:\n\n1. Subject is a male or female 18 years of age or older.\n2. Subject has a confirmed diagnosis of GBM according to the 2021 WHO Classification of Tumors of the CNS. Accordingly, eligible GBM patients will comprise only IDH-wild type astrocytomas with microvascular proliferation or necrosis or one or more of 3 genetic parameters (TERT promoter mutations, EGFR gene amplification, or combined gain of entire chromosome 7 and loss of entire chromosome 10).\n3. Subject has a Karnofsky Performance Status (KPS) 70% or greater.\n4. Subject has a life expectancy of at least 6 months, in the opinion of the Investigator.\n5. Subject must be able to undergo MRI evaluation.\n6. Subject meets the following laboratory criteria:\n\n   i. White blood count ≥ 3,000\u002FμL ii. Absolute neutrophil count ≥ 1,500\u002FμL iii. Platelets ≥ 100,000\u002FμL iv. Hemoglobin \\> 10.0 g\u002FdL (transfusion and\u002For ESA allowed) v. Total bilirubin and alkaline phosphatase ≤ 2x institutional upper limit of normal (ULN) vi. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3 x ULN vii. Blood urea nitrogen (BUN) and creatinine \\\u003C 1.5 x ULN\n7. Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control.\n8. Males of reproductive potential must be willing to use an acceptable method of birth control to ensure effective contraception with partner.\n9. Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted).\n\nExclusion Criteria:\n\n1. Subject has initiated chemotherapy or radiation treatment for diagnosis of or GBM.\n2. Subject has an IDH mutant astrocytoma or other non GBM brain tumor according to the 2021 WHO classification of Tumors of the CNS.\n3. Subject intends to participate in another clinical trial\n4. Subject has an active infection requiring treatment.\n5. Subject has radiographic evidence of multi-focal disease or leptomeningeal dissemination.\n6. Subject has a history of other malignancy unless the patient has been disease-free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatment\n7. Subject has a known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection.\n8. Subject has a history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n9. Subject, if female, is pregnant or is breast feeding.",{"count":83,"type":20},432,[85],"PHASE3","Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology.\n\nThe investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg\u002Fkg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I\u002FII clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.",[26,57,56,59,60,88,28],"Glioblastoma, IDH-wildtype",{"date":68,"type":35},{"date":91,"type":35},"2022-04-27",{"date":93,"type":20},"2028-04-01",{"name":74,"class":42},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":112,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":134},"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":104,"type":20},50,[85],"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.",[108,26,109,110,28,111],"Neoplastic Disease","Glioblastoma (GBM)","Glioblastoma Multiform","Glioblastoma Multiforme (GBM) WHO Grade IV",[113,114,115,116,117,57,26,59,118,119,120,121,122,123],"Lomustine","Radiation Therapy","Radiopharmaceuticals","Positron-Emission Tomography","Brain Neoplasms","Neoplasm Recurrence, Local","Central Nervous System Neoplasms","Brain cancer","Recurrent brain tumor","Brain tumor recurrence","LAT-1 targeted therapy","2026-04-15",{"date":126,"type":35},"2026-04-16",{"date":128,"type":35},"2025-11-02",{"date":130,"type":20},"2027-11",{"name":132,"class":133},"Telix Pharmaceuticals (Innovations) Pty Limited","INDUSTRY",4,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":152,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100554275","phase-3-a-prospective-pivotal-study-to-evaluate-the-efficacy-and-safety-of-avastin-bevacizumab-bev-with-or-without-microbubble-mediated-focused-ultrasound-fus-mb-using-navifus-system-in-recurrent-glioblastoma-multiforme-patients-100554275","NCT06496971","A Prospective Pivotal Study to Evaluate the Efficacy and Safety of Avastin® Bevacizumab (BEV) With or Without Microbubble-mediated Focused Ultrasound (FUS-MB) Using NaviFUS System in Recurrent Glioblastoma Multiforme Patients","A Prospective, Randomized, Standard of Care Controlled, Parallel, Open-Label, Multicenter Pivotal Study to Evaluate the Efficacy and Safety of Avastin® in Combination With NaviFUS System Compared With Avastin® Alone for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age at the time of study enrollment.\n2. Body mass index (BMI) ≥ 17 kg\u002Fm2.\n3. Patients diagnosed with glioblastoma must have unequivocal evidence of recurrence, as determined by contrast-enhanced magnetic resonance imaging (CE-MRI), following prior radiotherapy and temozolomide chemotherapy.\n4. Patients may have undergone surgery for recurrence. The patients should have completed surgery and adequately recovered prior to the time of study enrollment.\n5. Patients must have radiographic evidence of either at least an 80% resection of enhancing tumor following recurrence or a maximal measurable residual tumor ≤ 20 cm3.\n6. If patients are receiving corticosteroids, they must have been on a stable or decreasing dose of corticosteroids for at least 1 week prior to the planned first treatment.\n7. At the time of study enrollment, the minimum interval since the last event:\n\n   * 4 weeks out from invasive procedures (e.g., open biopsy, surgical resection, significant traumatic injury, or any other major surgery involving entry into a body cavity) and the patient must have recovered from the effects of surgery\n   * 1 week out from minor surgical procedures or core biopsies\n8. Patients must have recovered from the toxic effects of prior therapy at the time of study enrollment as follows:\n\n   * 4 weeks out from any investigational drug or device\n   * 4 weeks out from chemotherapy\n   * 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., Carmustine (BCNU))\n   * 12 weeks out from completion of radiotherapy\n9. Patients should have a life expectancy ≥ 12 weeks.\n10. Patients must have Karnofsky Performance Status (KPS) ≥ 70.\n11. Adequate hematopoietic, renal, hepatic, and coagulation function, defined as:\n\n    * Hemoglobin ≥ 10 g\u002FdL\n    * Platelets ≥ 100,000\u002Fmm3\n    * Neutrophils ≥ 1,500\u002Fmm3\n    * Serum creatinine ≤ 1.5 × upper limit of normal (ULN)\n    * Urine protein creatinine ratio (UPCR) \\\u003C 1 or urine dipstick for proteinuria ≤ 2+\n    * Alanine aminotransferase (ALT) \\\u003C 3 × ULN\n    * Aspartate aminotransferase (AST) \\\u003C 3 × ULN\n    * Total bilirubin (TBL) \\\u003C 2 × ULN\n    * Prothrombin time ≤ 1.5 x ULN\n    * International Normalized Ratio (INR) \\\u003C 1.5 These tests must be conducted within 2 weeks prior to the planned first treatment.\n12. The central of FUS exposure region is located with a minimum distance of at least 30 mm beneath the skull bone.\n13. Females of childbearing potential must have a negative pregnancy test documented within 2 weeks prior to first treatment. Females of childbearing potential and male patients with partners of childbearing potential must agree to adhere to an acceptable method of contraception (as outlined below) from prior to the first study treatment until at least 6 months after the completion of last treatment. Standard acceptable methods of contraception include the use of highly effective methods such as hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, or abstinence from sexual activity.\n14. Patients are able and willing to have peripheral intravenous (IV) line placement of Bevacizumab and are able to have hair shaved (either whole head or in the region where the coupling membrane will touch) prior to FUS treatment if assigned to treatment group.\n15. Patients or their legal representatives are able to provide written informed consent for participation in the trial and patients are willing to comply the procedures (i.e., study-related assessments), instructions, and restrictions outlined in this study in the duration of the study. Informed consent should also be given for biological materials and diagnostic imaging to be stored and used for future research on brain tumors.\n\nExclusion Criteria:\n\n1. Patients who have radiographic evidence of multifocal enhancing tumors.\n2. Patients who have undergone previous treatment with anti-angiogenic therapy, including Bevacizumab, or other VEGF inhibitors or VEGF-receptor signaling inhibitors.\n3. Patients who have previously received Carmustine wafers implantation during re-operation.\n4. Patients who have previously received or are currently undergoing tumor treating fields (TTF) treatment.\n5. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * New York Heart Association (NYHA) Grade II or above congestive heart failure (CHF) within 12 months prior to study enrollment\n   * Unstable angina pectoris\n   * Medical history of myocardial infarction within 6 months prior to study enrollment\n   * Cardiac shunt\n6. Stroke (except for transient ischemic attack; TIA) within 6 months prior to study enrollment.\n7. Patients with implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator (RNS), deep brain stimulation (DBS), or other electronic devices implanted in the brain. Patients with contraindications for MRI as judged by Investigator, including non-MRI compatible metallic implant(s).\n8. Patients with inadequately controlled hypertension, defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg while on medication, within 2 weeks prior to first treatment.\n9. Patients with evidence of any thrombotic or hemorrhagic events, including but not limited to:\n\n   * Inherited bleeding diathesis or significant coagulopathy with the risk of bleeding (i.e., in the absence of therapeutic anticoagulation).\n   * History of pulmonary haemorrhage\u002Fhaemoptysis ≥ grade 2 according to the CTCAE version 5.0 criteria within 1 month prior to study enrollment\n   * Arterial or venous thrombosis (e.g., pulmonary embolism) within 3 months prior to study enrollment\n10. Patients with unstable pulmonary disease or chronic obstructive pulmonary disease (COPD) exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study enrollment.\n11. Patients who have psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n12. Known HIV-positive patient, however, that HIV testing is not required for entry into this study.\n13. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of study enrollment.\n14. History or evidence of active gastroduodenal ulcer, gastrointestinal perforations\u002Ffistula, or intra-abdominal abscess within 6 months prior to study enrollment.\n15. Receiving anticoagulant (e.g., warfarin or LMW heparin) or antiplatelet (e.g., aspirin) therapy within 1 week prior to beginning treatment.\n16. Known sensitivity\u002Fallergy to Magnetic Resonance Imaging (MRI) contrast agents, Computer Tomography (CT) contrast agents, SonoVue®, Bevacizumab, or any of their components.\n17. Pregnant (positive pregnancy test) or breast-feeding women.\n18. Use of any recreational drugs or history of drug addiction.\n19. Other severe concurrent and\u002For uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection, uncontrolled epilepsy, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol.\n20. Any other condition that, in the Investigator's discretion, might increase the risk to the patients or compromise the evaluation of the clinical trial endpoints.","80 Years",{"count":52,"type":20},[85],"This will be a prospective, randomized, standard of care (SoC) controlled, parallel, open-label, multicenter pivotal study to investigate the efficacy and safety of Bevacizumab (BEV) in combination with or without microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.",[57,26,28,147,148,149,150,151],"Glioma","Brain Tumor","Brain Tumor, Recurrent","Neoplasms","Neoplasms, Nerve Tissue",[153,154,155,156,157,158,159,160,161],"NaviFUS System","Blood-Brain Barrier Opening","Focused Ultrasound","FUS","Low-Intensity Focused Ultrasound","LIFU","Bevacizumab","BEV","Avastin","2026-04-06",{"date":164,"type":35},"2026-04-09",{"date":166,"type":35},"2024-11-08",{"date":168,"type":20},"2027-03-31",{"name":170,"class":133},"NaviFUS Corporation",2,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":21,"phases":182,"briefSummary":184,"conditions":185,"keywords":186,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100489477","phase-2-simultaneous-integrated-boost-fdopa-positron-emission-tomography-pet-guided-in-patients-with-partially--or-non-operated-glioblastoma-100489477","NCT05653622","Simultaneous Integrated Boost FDOPA Positron Emission Tomography (PET) Guided in Patients With Partially- or Non-operated Glioblastoma","Simultaneous Integrated Boost FDOPA PET Guided in Patients With Partially- or Non-operated Glioblastoma","SIB-DOPA","Inclusion Criteria:\n\n* Unfit patient without indication to the STUPP protocol :\n\nCohort 1 : Non-operable patients and ≥ 18 years old or ≤ 70 years old and Karnofsky Index (KI) ≥ 50% on inclusion AND Result of a biopsy available Cohort 2 : Patients \\> 70 years old and Balducci score I or II and KI ≥ 60% on inclusion AND Partial resection (defined on the remnographic criteria of postoperative MRI) OR biopsy result available\n\n* Histologically proven glioblastoma\n* Increased metabolism of amino acids in PET FDOPA allowing contouring the Biological Target Volume (BTV)\n\nExclusion Criteria:\n\n* Patients with an indication for irradiation according to the STUPP protocol (fit patient)\n* Patient with a contraindication to MRI or PET\n* Limit of the provisional target volume or Planning target volume (PTV), second PTV \\\u003C 2 cm from the chiasm and the optic nerves\n* Absence of uptake of FDopa",{"count":181,"type":20},75,[183],"PHASE2","Glioblastoma (GBM) is the most common primary brain cancer in adults. Surgery, chemoradiotherapy (temozolomide TMZ) and then adjuvant TMZ is the standard treatment. But, most patients relapse in a median time of 8-9 months; the median overall survival (OS) ranged from 15 to 18 months.\n\nSome frail patients received hypofractionated radiation and concomitant and adjuvant TMZ. For some, the radiation dose is not optimal. Moreover, recurrences develop mainly in the initial tumor site. These two reasons justify increasing the dose. To limit the movements of these fragile patients, the method consists of increasing the dose without increasing the number of sessions by using the Simultaneous Integrated Boost (SIB) which increases the dose in targeted volumes while the rest of the volume receives a minimum dose. A phase I trial showed the possibility of increasing the dose in SIB up to 80 Gy in a part of the GBM enhanced on MRI.\n\nFDOPA PET detects certain more aggressive tumor areas, areas likely to recur. Integrating them into the SIB seems appropriate. A phase II trial showed the interest of SIB guided by FDOPA PET in terms of progression-free survival but without impact on OS. This study differed from the one the investigators propose, because a dose and conventional fractionation, identical to that of the European Organization for Research and Treatment of Cancer\u002FNational Cancer Information Center (NCIC\u002FEORTC) protocol were delivered, the gliomas were unmethylated MGMT, less likely to respond. Studies with SIB and hypofractionation are often retrospective and for others, hypofractionation was debatable and the dose increase was not based on PET capture but on MRI. However, a prospective phase II study, with SIB and hypofractionation, not integrating FDopa PET has demonstrated the relevance of SIB.\n\nIn this project, the investigators propose to use the integrated boost technique (SIB) guided by PET FDOPA to increase the radiation dose in GBM, in patients either fragile and partially operated, or only biopsied and for whom the prognosis is the most pejorative.",[28],[187,188,189],"glioblastoma","intensity modulated radiation therapy","18F-DOPA-PET imaging","2026-02-02",{"date":192,"type":35},"2026-02-04",{"date":194,"type":35},"2025-06-23",{"date":196,"type":20},"2029-07-01",{"name":198,"class":42},"Centre Paul Strauss",3,{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":43},"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":208,"type":20},190,[183],"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.",[26,60,57,212,28,213,214],"Glioblastoma Multiforme of Brain","MGMT-Unmethylated Glioblastoma","MGMT-Methylated Glioblastoma","2025-12-23",{"date":217,"type":35},"2025-12-26",{"date":219,"type":35},"2025-12-03",{"date":221,"type":20},"2030-12",{"name":223,"class":42},"Baptist Health South Florida",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":43},"100443327","phase-2-hstar-gbm-hematopoetic-stem-cell-hpc-rescue-for-gbm-100443327","NCT05052957","hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)","Phase II Trial O6-benzylguanine(BG) and Temozolomide(TMZ) Therapy of Glioblastoma Multiforme (GBM) With Infusion of Autologous P140K MGMT+Hematopoietic Progenitors to Protect Hematopoiesis","hSTAR GBM","Inclusion Criteria:\n\n* Patients with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone gross total tumor resection or near gross total resection (resection of \\>85% of enhancing tumor demonstrated by MRI) are eligible up to 35 days post-operatively. Patients with primarily infratentorial disease, or with multifocal,or leptomeningeal dissemination of disease will be excluded. In general, patients will not have \\> 1 cm residual measurable or evaluable disease after surgical tumor resection.\n* Patient must have unmethylated MGMT\n* Absence Of IDH1 or IDH2mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing\n* Patients aged 18-75 years.\n* ECOG performance status 0-1or Karnofsky ≥ 70.\n* No myelosuppressive chemotherapy or hematopoietic cell transplantation prior to the diagnosis of GBM and no prior chemotherapy (including Gliadel BCNU wafers) for GBM\n* Life expectancy of at least 12 weeks.\n* No plan for hypofractionated radiation therapy\n* Adequate hematologic (absolute neutrophil count (ANC)≥ 1000\u002Fmm3, platelets ≥ 100,000\u002Fmm3, Hgb ≥ 9.5, hepatic (Bilirubin ≤ 2.0 mg\u002Fdl, AST and ALT less than or equal to 3 times institutional upper limit of normal, prothrombin time \\\u003C1.2 times normal), and renal (serum creatinine ≤ 2.0 mg\u002Fdl or Creatinine Clearance ≥ 60mL\u002Fmin\u002F1.73 m2for subjects with serum creatinine levels above institutional normal). These tests will be repeated within 2 weeks of treatment with BG and TMZ, and must meet the same criteria. -Post-operative steroids are i) tapered to ≤ 8mg dexamethasone\u002Fday(or equivalent)and ii) patient has been on a stable or decreasing steroid dose for the 7 days prior to enrollment\n* Patients of child-bearing potential must agree to using single barrier contraception.\n* Must be willing and able to understand provide informed consent.\n* Patient must have all sutures removed prior to registration\n* Patient must be considered to be clinically stable.\n* The subject will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care. Participants will be screened by their transplant physician and social work for a history of substance abuse per screening tool such as SIPAT. Any participant with positive screen for significant substance abuse will undergo evaluation and must have a treatment, management plan in place and must have formal review of medical team prior to initiation of transplant procedures.\n* No evidence of active infection.\n* Availability of 10unstained slides or FFPE sample of tumor for molecular or histopathological studies.\n* Negative screening for Hepatitis B, C and HIV\n\nExclusion Criteria:\n\n* Any known medical or hereditary condition associated with immunosuppression;orothermedical illness which may jeopardize patient safety.\n* Known history of HIV seropositivity. This exclusion is included for two reasons. First, there is evidence of decreased marrow reserve in HIV+ patients and antiviral treatment is associated with myelosuppression. Thus, drug treatment designed to be myelosuppressive may bemore toxic in this patient population. Second, extensive laboratory culturing of the bone marrow and peripheral blood progenitor cells is required. No preclinical samples which are HIV+ have been evaluated with the gene transfer modality proposed and thus the feasibility and safety of gene transfer and selection in HIV+ samples cannot yet be advocated. Such studies are planned so as to not preclude HIV+ patients in later studies.\n* Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the fetus.\n* Patients with symptomatic pulmonary disease and other severe co-morbid respiratory conditions, including patients with active pulmonary infection and\u002For pulse oximetry \\\u003C 90% and a corrected DLCO \\\u003C 50% of predicted. However, subjects with a corrected DLCO in the range of 50-70% should have Pulmonologyclearance prior to intervention.\n* Patients with known diagnosis heart failure or cardiac insufficiency and an LVEF of \\\u003C 40%. History of acute coronary event including MI within 6 months prior to study enrollment.\n* Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmiaor bradycardia.Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadolinium-containing contrast agent.\n* Active illicit drug use or diagnosis of alcoholism.\n* Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situof the cervix, bladder, prostate, or breast, unless patient has been disease-free\u002Fin remission for ≥2 years prior to date of study enrollment.\n* Mental incapacity or psychiatric illness preventing informed consent.\n* History of Hepatitis B or C or Hepatitis grade ≥3 are excluded due to the potential for additional hepatotixicity","75 Years",{"count":234,"type":20},16,[183],"This phase II trial studies the effect of P140K MGMT hematopoietic stem cells, O6-benzylguanine, temozolomide, and carmustine in treating participants with supratentorial glioblastoma or gliosarcoma who have recently had surgery to remove most or all of the brain tumor (resected). Chemotherapy drugs, such as 6-benzylguanine, temozolomide, and carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing. Placing P140K MGMT, a gene that has been created in the laboratory into bone marrow making the bone more resistant to chemotherapy, allowing intra-patient dose escalation which kills more tumor cells while allowing bone marrow to survive.",[57,28,238,239],"Supratentorial Glioblastoma","Supratentorial Gliosarcoma","2025-11-19",{"date":242,"type":35},"2025-11-21",{"date":244,"type":35},"2023-01-20",{"date":246,"type":20},"2026-12-01",{"name":248,"class":42},"Leland Metheny",{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":256,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":171},"100589455","prognostic-potential-of-olfactory-function-in-glioblastoma-a-prospective-observational-study-100589455","NCT06954636","Prognostic Potential of Olfactory Function in Glioblastoma: a Prospective Observational Study","OLFGBM","Inclusion Criteria:\n\n* At least 18 years of age\n* Newly-diagnosed glioblastoma (IDH wild-type)\n* Never received prior chemotherapy\n* Never received radiotherapy to the head or neck before\n* KPS ≥ 70\n* No history of severe head or brain trauma requiring ICU admission or classified as Glasgow Coma Scale grade 3\n* No respiratory infection at the time of inclusion\n* No significant aphasia\n\nExclusion Criteria:\n\n* Presence of Neurodegenerative diseases (e.g. Parkinson's disease, Alzheimer's disease, Huntington's disease, Korsakoff's syndrome, Pick's disease, Shy-Drager syndrome)\n* History of invasive tumors or surgery in the head or neck area, except for surgeries for non-invasive skin tumors (e.g. basal cell carcinomas)\n* Permanent olfactory impairment following infections (e.g., influenza, coronavirus)\n* Conditions that, in the examiner's judgment, could interfere with the participant's study compliance (e.g., schizophrenia)\n* Language barriers likely to interfere with participation or comprehension of study procedures.",true,{"count":258,"type":20},128,"OBSERVATIONAL","The study aims to investigate the prognostic significance of olfactory function in patients with glioblastoma. We are examining olfactory function at various points during therapy and correlating the results with survival data. In addition, neurocognitive tests will be carried out to correlate the results of olfactory function with the patient's cognitive abilities. Investigations into the quality of life and psychological condition of the patients are also performed. In addition to the cohort of glioblastoma patients, there is a control cohort without tumor disease in which the olfactory testing is also carried out in order to have a comparison.",[28,262,263],"Glioblastoma or Gliosarcoma","Glioblastoma, Adult",[265,266,267,187,268,269,270,271,272],"olfactory dysfunction","threshold test","identification test","prognosis","observational study","olfactory function","neurocognition","quality of life","2025-07-02",{"date":275,"type":35},"2025-07-08",{"date":277,"type":35},"2023-05-03",{"date":279,"type":20},"2028-12-31",{"name":281,"class":42},"Sied Kebir",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":21,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":301,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":43},"100576136","patients-derived-organoids-for-drug-screening-in-glioblastoma-100576136","NCT06781372","Patient's Derived Organoids for Drug Screening in Glioblastoma","Development and Characterization of Patient's Derived Organoids as a Platform for the Screening of Novel Therapeutic Treatments for Glioblastoma Multiforme","GlioPDO","Inclusion Criteria:\n\n* adult patients undergoing resective neurosurgery for glioblastoma, IDH-wildtype\n\nExclusion Criteria:\n\n* Needle biopsies\n* Age \\\u003C18 years\n* Inability to give informed consent\n* Brain surgery for tumor disease other than GBM\n* Previous neoadjuvant chemotherapy or radiotherapy",{"count":291,"type":20},100,[23],"The study will enroll patients suffering from glioblastoma, a malignant brain tumor. Intervention is intended as a laboratory intervention and not as a clinical intervention. In fact, tumor removed from patients' brains will be sent to a dedicated laboratory to obtain an \"avatar\" of the tumor, named patient-derived organoid (PDO). A number of experimental antitumor approaches will be studied on PDOs. Results of these experiments will be correlated to the prognosis of patients.",[26,295,28],"Glioblastoma Multiforme (GBM)",[187,297,298,299,300],"patient derived organoid","transposable elements","splicing","immunotherapy","NOT_YET_RECRUITING","2025-03-11",{"date":304,"type":35},"2025-03-13",{"date":306,"type":20},"2025-04-01",{"date":308,"type":20},"2028-01-31",{"name":310,"class":42},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":322,"conditions":323,"keywords":327,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"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":321,"type":20},464,"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.",[26,57,88,212,28,324,325,326],"Recurrent Glioblastoma","Astrocytoma, Malignant","Astrocytoma of Brain",[26,328,329,330,331,332,333,334,335,336,337],"Radiotherapy","Chemotherapy","Re-resection","Resection","Overall survival","Progression-free survival","Neurological morbidity","Safety","Serious Adverse Events","Quality of life","2024-02-21",{"date":340,"type":35},"2024-02-28",{"date":342,"type":35},"2023-01-01",{"date":344,"type":20},"2028-01-01",{"name":346,"class":42},"Jasper Gerritsen",8,{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":356,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":358,"conditions":359,"keywords":367,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":377,"locationsCount":347},"100525206","the-supramax-study-supramaximal-resection-versus-maximal-resection-for-high-grade-glioma-patients-encram-2201-100525206","NCT06118723","The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)","SUPRAMAX","Inclusion Criteria:\n\n1. Age ≥18 years and ≤90 years\n2. Tumor diagnosed as HGG (WHO grade III\u002FIV) on MRI as assessed by the neurosurgeon\n3. Written informed consent\n\nExclusion Criteria:\n\n1. Tumors of the cerebellum, brainstem or midline\n2. Multifocal contrast enhancing lesions\n3. Medical reasons precluding MRI (e.g. pacemaker)\n4. Inability to give written informed consent\n5. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n6. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin",{"count":357,"type":20},784,"A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.\n\nThe study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).",[26,360,88,361,28,362,363,325,117,364,365,366],"High-grade Glioma","Glioblastoma, IDH-mutant","Astrocytoma, Grade IV","Astrocytoma, Grade III","Brain Neoplasm, Primary","Brain Neoplasms, Adult","Brain Neoplasm, Malignant",[26,368,369,370,334,337,332,333],"Supramaximal resection","FLAIRectomy","Non-contrast enhancement","2024-02-20",{"date":373,"type":35},"2024-02-22",{"date":375,"type":35},"2022-01-01",{"date":344,"type":20},{"name":346,"class":42},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":385,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":347},"100527359","the-palsur-study-palliative-care-versus-surgery-in-high-grade-glioma-patients-encram-2203-100527359","NCT06146738","The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)","PALSUR","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. Inability to give written informed consent\n3. Secondary high-grade glioma due to malignant transformation from low-grade glioma\n4. 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":386,"type":20},1015,"There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively.\n\nThis study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.",[26,57,88,28],[390,391,392,331,337,393,26],"Palliative care","Best supportive care","Biopsy","Survival","2023-11-18",{"date":396,"type":35},"2023-11-27",{"date":342,"type":35},{"date":399,"type":20},"2029-01-01",{"name":346,"class":42},{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":406,"eligibilityCriteria":407,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":319,"enrollmentInfo":408,"targetDuration":4,"studyType":259,"phases":4,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":416,"locationsCount":347},"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":409,"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.",[26,88,57,28,212],[331,392,393,337],{"date":396,"type":35},{"date":342,"type":35},{"date":399,"type":20},{"name":346,"class":42}]