[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100324915":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":92,"collaborators":94,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":62,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":62,"enrollmentInfo":109,"targetDuration":62,"studyType":112,"phases":113,"briefSummary":116,"conditions":117,"keywords":62,"overallStatus":76,"whyStopped":62,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Stanford University","OTHER",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 -50mg panitumumab-IRDye800","EXPERIMENTAL","A panitumumab-IRDye800 dose of 50mg (Cohort 1) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.",[13,14,15,16],"Procedure: Near-Infrared Fluorescence Imaging","Biological: Panitumumab","Drug: Panitumumab-IRDye800","Device: POINPOINT-IR9000",{"label":18,"type":10,"description":19,"interventionNames":20},"Cohort 2 -100mg panitumumab-IRDye800","A panitumumab-IRDye800 dose of 100mg (Cohort 2) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort 3 -100mg panitumumab-IRDye800","Cohort 3 dose will be determined based on Cohort 1 and Cohort 2, with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort 4","Cohort 4 will enroll 24 participants with vestibular schwannomas at the optimal dose of 100mg, as determined by the research team based on data analysis from the first two cohorts.",[13,14,15,16],[30,38,50,57],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","Near-Infrared Fluorescence Imaging","Undergo NIR imaging",[9,18,22,26],[36,37],"NIR Fluorescence Imaging","NIR Optical Imaging",{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"BIOLOGICAL","Panitumumab","Given IV",[9,18,22,26],[44,45,46,47,48,49],"ABX-EGF","ABX-EGF Monoclonal Antibody","ABX-EGF, Clone E7.6.3","MoAb ABX-EGF","Monoclonal Antibody ABX-EGF","Vectibix",{"type":51,"name":52,"description":41,"armGroupLabels":53,"otherNames":54},"DRUG","Panitumumab-IRDye800",[9,18,22,26],[55,56],"Panitumumab IRDye 800","RDye800-Panitumumab Conjugate",{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"DEVICE","POINPOINT-IR9000","Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and\u002For on ex-vivo resected tissues in the surgery suite (\"back table\").",[9,18,22,26],null,[64],{"name":65,"affiliation":5,"role":66},"Lindsay Moore, MD","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":62,"email":72},"Sandra Torres","CONTACT","(650) 723-5281","sandraet@stanford.edu",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Stanford University School of Medicine","RECRUITING","Palo Alto","California","94304","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-122.14302,37.44188,{"lat":86,"lon":85},[89,91],{"name":69,"role":70,"phone":90,"phoneExt":62,"email":72},"650-723-5281",{"name":65,"role":66,"phone":62,"phoneExt":62,"email":62},{"type":93,"investigatorFullName":62,"investigatorTitle":62,"investigatorAffiliation":62,"oldNameTitle":62,"oldOrganization":62},"SPONSOR",[95,98],{"name":96,"class":97},"National Institutes of Health (NIH)","NIH",{"name":99,"class":97},"National Cancer Institute (NCI)","100324915","phase-1-panitumumab-irdye800-in-diagnosing-participants-with-malignant-glioma-undergoing-surgery-100324915",false,"NCT03510208","Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery","Phase I\u002FII, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures","Inclusion Criteria:\n\n1\\) One of the following:\n\n1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma\n2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma\n\n   2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and\u002For participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.\n\n   3\\) Participant age ≥ 18 years.\n\n   4\\) Participants or their designated advocates must be willing to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n\nExclusion Criteria:\n\n1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.\n2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.\n3. History of infusion reactions to monoclonal antibody therapies\n4. Pregnant or breastfeeding.\n5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).\n6. Any of the following lab values:\n\n   1. Platelet count \\\u003C 75,000\u002Fmm3\n   2. TSH ≥ 13 micro International Units\u002FmL.\n   3. Magnesium, potassium, or calcium \\\u003C each respective upper limit of normal\n   4. Serum creatinine \\> 1.5 times upper limit of normal\n7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.\n8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.\n9. Participants not deemed by PI to be appropriate candidates for optimal resection of tumor based on location, involvement of eloquent brain, satellite lesions, or other factors not specifically listed here.","ALL","18 Years",{"count":110,"type":111},46,"ESTIMATED","INTERVENTIONAL",[114,115],"PHASE1","PHASE2","The phase I\u002FII trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.",[118,119],"Malignant Brain Neoplasm","Malignant Glioma","2026-06-26",{"date":122,"type":123},"2026-06-29","ACTUAL",{"date":125,"type":123},"2018-05-16",{"date":127,"type":111},"2026-11",{"name":5,"class":6},1]