[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eben Rosenthal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":102},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,77],{"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":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":20,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100630882","early-phase-1-pilot-study-evaluating-panitumumab-irdye800-as-an-optical-imaging-agent-to-detect-intracranial-lesions-during-neurosurgical-procedures-100630882","NCT07493447","Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures","Inclusion Criteria:\n\n* Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and\u002For radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.\n* Subject age ≥ 18 years.\n* Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:\n\n  1. Chemistry Panel - Potassium, BUN (or urea), and Creatinine\n  2. CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count\n  3. Magnesium and Phosphorus\n* Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration.\n* Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker.\n\nExclusion Criteria:\n\n* Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.\n* History of infusion reactions to any monoclonal antibody therapies.\n* Women who are currently pregnant or breastfeeding.\n* Participants presenting with a baseline QTcF interval \\> than 480 milliseconds.\n* Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.\n* Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n* Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n* Patients with severe renal disease or anuria",{"count":55,"type":19},30,[22],"This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.",[59,60,61,25,62],"Meningioma","Glioblastoma","Acoustic Neuroma","Pituitary Adenoma",[64,65,66,60,59,62,61,67,68],"Cancer","Malignant","Benign","Brain Masses","Intracranial Lesion","2026-06-26",{"date":71,"type":39},"2026-06-30",{"date":73,"type":19},"2026-07",{"date":75,"type":19},"2031-06",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":15,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":20,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":47},"100496698","phase-1-89zr-panitumumab-with-petct-for-diagnosing-metastases-in-patients-with-head-and-neck-squamous-cell-carcinoma-100496698","NCT05747625","(89Zr Panitumumab) With PET\u002FCT for Diagnosing Metastases in Patients With Head and Neck Squamous Cell Carcinoma","Study Evaluating 89Zr Panitumumab for Assessment of Indeterminate Metastatic Lesions on 18F-FDG-PET\u002FCT in Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Age \\>= 19 years\n* Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck\n* Subjects diagnosed with any T stage, any subsite within the head and neck. Subjects with recurrent disease or a new primary will be allowed\n* Must have evidence of indeterminate metastatic squamous cell carcinoma (SCC) based on 18F-fluorodeoxyglucose (FDG)-PET\u002FCT or Primary SCC with suspicious Lymph Nodes on CT prior to surgical removal\n* Hemoglobin \\>= 9gm\u002FdL\n* White blood cell count \\> 3000\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Serum creatinine =\\\u003C 1.5 times upper reference range\n\nExclusion Criteria:\n\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* History of infusion reactions to other monoclonal antibody therapies\n* Pregnant (based on screening serum pregnancy test and day 0 urine pregnancy test administered before unlabeled panitumumab), or breastfeeding\n* Magnesium or potassium lower than the normal institutional values\n* Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Severe renal disease or anuria\n* Known hypersensitivity to deferoxamine or any of its components","19 Years",{"count":86,"type":19},60,[88],"PHASE1","The goal of this phase I clinical trial is to evaluate the usefulness of an imaging test (zirconium Zr89 panitumumab \\[89Zr panitumumab\\]) with positron emission tomography (PET)\u002Fcomputed tomography (CT) for diagnosing the spread of disease from where it first started (primary site) to other places in the body (metastasis) in patients with head and neck squamous cell carcinoma. Traditional PET\u002FCT has a low positive predictive value for diagnosing metastatic disease in head and neck cancer. 89Zr panitumumab is an investigational imaging agent that contains radiolabeled anti-EGFR antibody which is overexpressed in head and neck cancer. The main question this study aims to answer is the sensitivity and specificity of 89Zr panitumumab for the detection of indeterminate metastatic lesions in head and neck cancer.\n\nParticipants will receive 89Zr panitumumab infusion and undergo 89Zr panitumumab PET\u002FCT 1 to 5 days after infusion. Participants will otherwise receive standard of care evaluation and treatment for their indeterminate lesions.\n\nResearchers will compare the 89Zr panitumumab to standard of care imaging modalities (magnetic resonance imaging (MRI), CT, and\u002For PET\u002FCT).",[91,92,93],"Head and Neck Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck","2026-05-06",{"date":96,"type":39},"2026-05-08",{"date":98,"type":39},"2023-05-09",{"date":100,"type":19},"2030-03-01",{"name":45,"class":46},""]