Glioblastoma Clinical Trial
Official title:
Multispectral and Bimodal Fluorescent Guided Surgery (FGS) of High-grade Glioma for Refining Margin Assessment: A Phase 1 Dose Finding Study Using Cetuximab-IRDye800CW Combined With 5-ALA.
The MIRROR study is a prospective, single center phase I feasibility and dose finding study in patients with high-grade glioma, to establish the safety, feasibility, and optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery, in comparison to the standard of care (SOC), 5-ALA fluorescent imaging agent. The main research objectives of this study are: 1. To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery 2. To assess the safety and tolerability 3. To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging The study population will consist of patients, aged ≥18 years, diagnosed with high-grade glioma and scheduled for surgery.
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