[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369097":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":77,"collaborators":35,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":35,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":35,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":35,"overallStatus":62,"whyStopped":35,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Stanford University","OTHER",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1-0.006 Panitumumab-IRDye800","EXPERIMENTAL","Dose: 0.006 Panitumumab-IRDye800 (mg\u002Fkg)",[13,14,15,16],"Drug: Panitumumab-IRDye800","Device: Pinpoint-IR9000 endoscopic\u002Fhandheld device","Device: Explorer Air camera","Device: PDE-NEO-II",{"label":18,"type":10,"description":19,"interventionNames":20},"Cohort 2-0.25 Panitumumab-IRDye800","Dose: 0.25 Panitumumab-IRDye800 (mg\u002Fkg)",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort 3-0.50 Panitumumab-IRDye800","Dose: 0.50 Panitumumab-IRDye800 (mg\u002Fkg)",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort 4-1.0 Panitumumab-IRDye800","Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg\u002Fkg)",[13,14,15,16],[30,36,41,45],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Panitumumab-IRDye800","Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).",[9,18,22,26],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"DEVICE","Pinpoint-IR9000 endoscopic\u002Fhandheld device","Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and\u002For on the resected tissues while at the \"back table\" in the surgery suite (ex-vivo).",[9,18,22,26],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"Explorer Air camera","Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and\u002For on the resected tissues while at the \"back table\" in the surgery suite (ex-vivo).",[9,18,22,26],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":35},"PDE-NEO-II","Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and\u002For on the resected tissues while at the \"back table\" in the surgery suite (ex-vivo).",[9,18,22,26],[50],{"name":51,"affiliation":5,"role":52},"Laura Prolo, MD","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Nancy Sweeters","CONTACT","650-721-4074","nks2016@stanford.edu",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Stanford Cancer Center","RECRUITING","Stanford","California","94304","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-122.16608,37.42411,{"lat":72,"lon":71},[75,76],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},{"name":51,"role":52,"phone":35,"phoneExt":35,"email":35},{"type":78,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100369097","phase-1-panitumumab-irdye800-to-detect-pediatric-neoplasms-during-neurosurgical-procedures-100369097",false,"NCT04085887","Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures","Phase 1\u002FPhase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures","Inclusion Criteria:\n\n* Subjects with suspected brain tumors 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 felt to be candidates for resection.\n* Subjects must be eligible for resection as determined by the operating surgeon.\n* Planned standard of care surgery\n* Subject age 6 months to 25 years\n* Life expectancy of more than 12 weeks\n\nExclusion Criteria:\n\n* Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800\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 monoclonal antibody therapies\n* Pregnant or breastfeeding\n* Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8 years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to 18 year old females)\n* Magnesium, potassium and calcium \\\u003C the lower limit of normal per institution normal lab values\n* Serum creatinine \\> 1.5 times upper reference range\n* Other lab values that in the opinion of the primary surgeon would prevent surgical resection\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* Subjects not deemed 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","6 Months","25 Years",{"count":90,"type":91},12,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.",[98],"Brain Tumor","2026-06-26",{"date":101,"type":102},"2026-06-30","ACTUAL",{"date":104,"type":91},"2026-08",{"date":106,"type":91},"2028-12",{"name":5,"class":6},1]