Early Phase 1 Trial of Panitumumab-IRDye800 for Imaging Brain Tumors During Neurosurgery

What this Trial Is About

This research aims to evaluate the safety and imaging performance of panitumumab-IRDye800 pan800, a fluorescent imaging agent targeting EGFR, in adults undergoing neurosurgery to remove intracranial lesions such as meningioma, glioblastoma, acoustic neuroma, brain cancer, and pituitary adenoma. The study is an early phase 1 trial focused on supportive care to improve tumor visualization during surgery. Participants will receive a single intravenous dose of panitumumab-IRDye800 either 50 mg or 100 mg, administered 1 to 5 days before their planned neurosurgical resection. During surgery, near-infrared fluorescence imaging will be used to assess how well the agent highlights the tumor compared to normal brain tissue. After infusion, participants will be monitored immediately for adverse events and will have blood samples taken to study drug levels and immune response. Throughout the study, participants will be followed through their surgery and a follow-up call approximately 15 days after infusion to monitor safety. Standard medical care for their intracranial disease will continue as usual. Researchers will measure safety outcomes from infusion through 15 days post-infusion, and evaluate imaging effectiveness and optimal dosing within 14 days after surgery. Participation lasts from infusion through postoperative assessments and the follow-up period.

Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures