NCT05929456

Multispectral Bimodal Fluorescence Guided Surgery of High-grade Glioma With Cetuximab-800CW and 5-ALA (5-aminolevulinic Acid)

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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glioblastoma
• High-grade Glioma

Interventions

Type	Name	Description
DRUG	Cetuximab-IRDye800	patients will receive a single IV injection of Cetuximab-IRDye800CW 2-4 days prior to surgert. The IMP (Investigational medicinal product)/tracer will be used for fluorescence guided surgery.

Timeline

• Start date: 2023-05-05
• Primary completion: 2024-10-01
• Completion: 2025-01-01
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: Netherlands