Phase III Study of Panitumumab-IRDye800 for Imaging Malignant Glioma During Brain Surgery

What this Trial Is About

This research aims to evaluate panitumumab-IRDye800, an imaging agent studied for diagnosing malignant glioma in patients undergoing surgery. The study is a phase III trial focusing on the safety, best dose, and effectiveness of this agent in helping surgeons better see tumor cells compared to normal brain tissue. It also investigates whether a loading dose of panitumumab is needed and the best timing for surgery to maximize imaging quality. Participants receive an injection of panitumumab-IRDye800, at doses of 50 mg, 100 mg, or a dose determined by earlier groups, with or without a 100 mg loading dose of unlabeled panitumumab. This injection is given 1 to 5 days before their planned standard surgery. During surgery, near-infrared NIR imaging using a special camera is performed to help visualize tumors. One study group includes participants with vestibular schwannomas treated at the selected optimal dose. Participants are involved in surgery and imaging procedures and monitored for side effects up to 30 days. Researchers assess adverse events related to the study treatment, the ratio of tumor to background signal, the effect of loading dose, and optimal surgery timing. The study includes planned visits around the surgery and follow-up assessments up to one year. The total study duration is until November 2026, with detailed safety and imaging data collected throughout.

Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery