[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hgg\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hgg":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,89,124],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100609136","early-phase-1-window-trial-of-fluorescently-labeled-nivolumab-irdye800-nivo800-in-high-grade-glioma-hgg-100609136",false,"NCT07210632","Window Trial of Fluorescently Labeled Nivolumab-IRDye800 (Nivo800) in High Grade Glioma (HGG)","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Patient must have imaging of highly suspicious high grade glioma (HGG)\n4. Patients for whom surgical craniotomy is planned as standard of care (SOC)\n5. Adequate hematologic, hepatic function and end-organ function appropriate for surgical resection and anesthesia (within 30 days of infusion) WBC ≥ 2,000 (mcl) AST 9-80 (IU\u002FL) ALT 7-110 (IU\u002FL) BUN 6-50 (mg\u002FdL) Creatinine 0.5-3.0 (mg\u002FdL)\n\nExclusion Criteria:\n\n1. Patients not eligible for SOC surgical resection\n2. Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis with the following exceptions:\n\n   Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n\n   Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n\n   Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided if all the following conditions are met:\n\n   Rash must cover \\\u003C 10% of body surface area Disease is well controlled at baseline and requires only low-potency topical corticosteroids No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency oral corticosteroids within the previous 12 months\n3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n\n   History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n4. Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina.\n5. Severe unresolved infection within 4 weeks prior to initiation of study treatment.\n6. Prior allogeneic stem cell or solid organ transplantation\n7. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n8. Chronic treatment with systemic immunosuppressive medication in excess of physiologic maintenance doses of corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents), with the following exceptions:\n\n   Patients who received acute, systemic immunosuppressant medication or a dose of systemic immunosuppressant medication are eligible for the study.\n\n   Physiologic corticosteroid replacement therapy at doses ≤ 10 mg\u002Fday of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.\n\n   Patients with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.\n\n   Patients using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.\n\n   Brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy) or study treatment-related standard premedication is permitted.\n9. Pregnant or breastfeeding, or intention of becoming pregnant during study treatment or within 2 months after the final dose of study treatment.\n10. Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.","ALL","18 Years",{"count":18,"type":19},38,"ESTIMATED","INTERVENTIONAL",[22],"EARLY_PHASE1","High-grade gliomas (HGGs) are among the most aggressive and treatment-resistant brain tumors. Immunotherapy with checkpoint inhibitors like nivolumab has shown promise, but its efficacy remains variable and poorly understood in this patient population. This clinical trial investigates a novel imaging-enabled formulation of nivolumab-IRDye800 (nivo800) which incorporates a near-infrared (NIR) fluorescent dye to enable real-time visualization of drug distribution within tumor tissue.",[25,26,27,28,29,30,31],"Brain Cancer","HGG","Glioma","High Grade Glioma","High Grade Gliomas","High Grade Glioma (III or IV)","High Grade Glioma (HGG) of the Brain With BRAF Aberration",[33,34],"hgg","high grade glioma","RECRUITING","2026-06-29",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2026-03-27",{"date":43,"type":19},"2031-03-30",{"name":45,"class":46},"Eben Rosenthal","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":15,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":20,"phases":58,"briefSummary":60,"conditions":61,"keywords":72,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":80,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100480603","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-07799544-as-monotherapy-or-in-combination-in-people-with-advanced-solid-tumors-100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":57,"type":19},124,[59],"PHASE1","The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[62,27,63,64,65,66,67,26,68,69,28,70,71],"Melanoma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","LGG","Low Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[73,74,75,76,77,78,79],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600",{"date":38,"type":39},{"date":82,"type":39},"2022-11-30",{"date":84,"type":19},"2029-06-18",{"name":86,"class":87},"Pfizer","INDUSTRY",83,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":20,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100477963","phase-2-a-study-to-assess-the-efficacy-and-safety-of-fore8394-in-participants-with-cancer-harboring-braf-alterations-100477963","NCT05503797","A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations","A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations","Inclusion Criteria\n\nSubprotocol A:\n\n1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n2. Histologic diagnosis of a solid tumor or primary CNS tumor.\n3. Documentation of BRAF gene fusion in tumor and\u002For blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.\n4. Have an archival tissue sample available meeting protocol requirements.\n5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n6. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.\n\nSubprotocol B:\n\n1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n2. Histological diagnosis of a primary CNS tumor, including but not limited to the following:\n\n   1. Adults (≥18 years) with Grade 1-4 glioma or glioneuronal tumor (including glioblastoma, anaplastic astrocytoma, high grade astrocytoma with piloid features, pilocytic astrocytoma, gliosarcoma, anaplastic pleomorphic xanthoastrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, not otherwise specified \\[NOS\\], ganglioglioma, or recurrent LGG). OR\n   2. Pediatric patients (10-17 years of age) with a Grade 3 or 4 glioma or glioneuronal tumor, including those with a prior, histologically confirmed, diagnosis of a low-grade glioma or glioneuronal tumor and now have radiographic or histopathological findings consistent with WHO \\[2021\\] Grade 3 or 4 primary CNS tumor.\n   3. Participants must have unresectable, locally advanced or metastatic disease that:\n\n   i. Had prior treatment with radiotherapy and\u002For first-line chemotherapy or concurrent chemoradiation therapy OR\n   * Note: Participants who have a WHO Grade 3 or 4 glioma for whom chemotherapy and\u002For radiotherapy is not considered standard of care may remain eligible for the study.\n\n   ii. Is intolerant to available therapies OR iii. The investigator has determined that treatment with standard therapy is not appropriate.\n3. Documented BRAF V600E mutation in tumor and\u002For liquid biopsy detected by an analytically validated test at CLIA or CLIA-equivalent laboratory approved by sponsor or sponsor-designated central test.\n4. An archival tissue sample available meeting protocol requirements, or fresh biopsy is required if the archival sample is not available for retrospective confirmation test.\n5. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.\n6. Measurable disease based upon specified response criteria, as determined by the radiographic BICR.\n7. All adverse events related to prior therapies (eg, chemotherapy, radiotherapy, surgery) must have resolved to Grade 1 or baseline.\n8. Participants who are receiving corticosteroid treatment must be on a stable or decreasing dose of ≤8 mg\u002Fday of dexamethasone or equivalent corticosteroid treatment for 7 days prior to first dose of study treatments.\n\nSubprotocol C:\n\n1. Male and female, ≥10 years of age, and weighing ≥30 kg.\n2. Histologic diagnosis of a rare BRAF V600E-mutated solid tumor that is unresectable, locally advanced or metastatic.\n3. Measurable disease on CT, MRI, or physical exam\n4. Documented BRAF V600E mutation in tumor and\u002For liquid biopsy detected by an analytically validated test.\n5. Have an archival tissue sample available meeting protocol requirements.\n6. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory\n7. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.\n\nSubprotocol D:\n\n1. Male and female, 18 - 65 years of age.\n2. Histologic diagnosis of a solid tumor harboring a BRAF V600E mutation and not eligible for other subprotocols.\n3. Measurable disease on CT, MRI, or physical exam.\n4. Evidence of BRAF V600E mutation in tumor and\u002For blood detected by genomic tests.\n5. Consent to provide a tumor biopsy.\n6. Willingness to comply with the ECG substudy procedures.\n7. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.\n\nExclusion Criteria:\n\nSubprotocol A:\n\n1. Prior treatment with RAF\u002FBRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.\n2. Prior treatment with a MEK inhibitor.\n3. Tyrosine kinase inhibitor(s) and\u002For targeted therapies are allowed (other than BRAF\u002FMAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines.\n4. Malignancy with co-occurring activating RAS mutation(s) at any time.\n5. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n6. HIV infection with exceptions; discuss with treating physician.\n7. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).\n8. Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n\nSubprotocol B:\n\n1. Prior treatment with BRAF, ERK, and\u002For MEK inhibitor(s).\n2. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations.\n3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n4. Active infection requiring systemic therapy.\n5. HIV infection with exceptions; discuss with treating physician.\n6. Have impairment of GI function or GI disease that may significantly alter the absorption of oral plixorafenib (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).\n7. Grade ≥ 2 changes in AST, ALT, gamma-glutamyl transaminase (GGT), or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.\n\nSubprotocol C:\n\n1. Diagnosis of colorectal adenocarcinoma or pancreatic ductal adenocarcinoma (neuroendocrine or acinar tumors are eligible).\n2. Diagnosis of BRAF V600E-mutated cutaneous melanoma, papillary thyroid cancer, or NSCLC.\n3. Participant has CNS metastases.\n4. Prior treatment with BRAF, ERK, and\u002For MEK inhibitor(s), unless otherwise specified for specific tumor types (i.e. low grade serous or borderline ovarian cancer).\n5. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations.\n6. Participants with prostate, breast, or gynecologic cancers with known activating mutations that lead to constitutive hormone receptor activation (AR-V7, ESR1).\n7. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n8. Active infection requiring systemic therapy.\n9. HIV infection with exceptions; discuss with treating physician.\n\nSubprotocol D:\n\n1. Known or suspected neurofibromatosis-1 (NF-1) and\u002For RAS related gene alterations or other co-occurring driver mutations.\n2. Participant has a non-CNS solid tumor with CNS metastases.\n3. Uncontrolled intercurrent illness that would limit compliance with study requirements.\n4. Active infection requiring systemic therapy.\n5. HIV infection with exceptions; discuss with treating physician.\n6. Use or anticipate the need for medications with known risk for QT-prolonging potential and Torsades de Pointes.\n7. History of acute or chronic cardiovascular disease or surgery, hypertension, with systolic blood pressure \\>160mm HG, history of QTc abnormalities, or clinical significantly ECG abnormalities.","10 Years",{"count":98,"type":19},254,[100],"PHASE2","The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.",[103,26,68,104],"Cancer Harboring BRAF Alterations","Solid Tumors",[106,107,108,109,110,111,112,26,68,113],"BRAF alterations","BRAF Fusions","BRAF V600E","BRAF Class 1","BRAF Class 2","High grade glioma","low grade glioma","Solid tumors","2026-06-04",{"date":116,"type":39},"2026-06-05",{"date":118,"type":39},"2023-02-21",{"date":120,"type":19},"2026-12-28",{"name":122,"class":87},"Fore Biotherapeutics",70,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":20,"phases":134,"briefSummary":135,"conditions":136,"keywords":143,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":47},"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":133,"type":19},10,[59],"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.",[137,138,139,140,26,27,141,142],"GBM","Glioblastoma Multiforme (GBM)","Glioblastoma Multiforme of Brain","Glioblastoma Multiforme Glioma","Brain Tumor Adult","Brain Tumor, Primary",[144,145,137,146,147,148,149,150,151,152,153],"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":156,"type":39},"2025-09-17",{"date":158,"type":39},"2025-06-04",{"date":160,"type":19},"2027-11",{"name":162,"class":46},"Sunnybrook Health Sciences Centre"]