[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630882":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":54,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":24,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":24,"enrollmentInfo":66,"targetDuration":24,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Vanderbilt-Ingram Cancer Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study Arm - 50 mg pan800","EXPERIMENTAL","Participants will receive a single 50 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring, postoperative pharmacokinetic blood draws, and adverse-event assessments through surgery and a Day 15 (±7) follow-up.",[13],"Drug: Panitumumab-IRDye800",{"label":15,"type":10,"description":16,"interventionNames":17},"Study Arm - 100 mg pan800","Participants will receive a single 100 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before their standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring along with postoperative pharmacokinetic and immunogenicity blood sampling and adverse-event assessments through surgery and the Day 15 (±7) follow-up visit.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Panitumumab-IRDye800","Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion.",[15,9],null,[26],{"name":27,"affiliation":28,"role":29},"Peter Morone, MD","Vanderbilt University Medical Center","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Makenna Brown","CONTACT","615-421-4370","makenna.l.brown@vumc.org",{"name":37,"role":33,"phone":38,"phoneExt":24,"email":39},"Nicole Jones","615-936-2807","nicole.l.jones@vumc.org",[41],{"facility":28,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":24},"RECRUITING","Nashville","Tennessee","37232-0004","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-86.78444,36.16589,{"lat":52,"lon":51},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Eben Rosenthal","Barry and Amy Baker Professor and Chair","100630882","early-phase-1-pilot-study-evaluating-panitumumab-irdye800-as-an-optical-imaging-agent-to-detect-intracranial-lesions-during-neurosurgical-procedures-100630882",false,"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","ALL","18 Years",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"EARLY_PHASE1","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.",[74,75,76,77,78],"Meningioma","Glioblastoma","Acoustic Neuroma","Brain Cancer","Pituitary Adenoma",[80,81,82,75,74,78,76,83,84],"Cancer","Malignant","Benign","Brain Masses","Intracranial Lesion","2026-06-26",{"date":87,"type":88},"2026-06-30","ACTUAL",{"date":90,"type":68},"2026-07",{"date":92,"type":68},"2031-06",{"name":56,"class":6},1]