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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
21
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.
UMCG
Groningen, Netherlands
RECRUITINGOptimal dosage
To determine the optimal dosage of Cetuximab-IRDye800CW for fluorescence guided surgery of high-grade glioma using Near- Infrared (NIR) fluorescence imaging
Time frame: 1 day
To assess the safety and tolerability of intravenous tracer administration by measuring/registering the number(S)AEs and SUSARs that have occurred during the duration of the trial
The (S)AEs and SUSARS will be reported according to the CTCAE v4.0
Time frame: 4-5 days
In vivo/ex vivo correlation
To correlate fluorescent signals measured by in vivo multispectral imaging with Cetuximab-IRDye800CW and 5-ALA with those measured by ex vivo imaging
Time frame: 1 day
Fluorescent signals vs pathology
To correlate the presence of pathologically confirmed EGFR(epidermal growth factor receptor)-gene amplification with the presence of fluorescence signals, in- and ex vivo, as measured with NIR fluorescent imaging after administering Cetuximab-IRDye800CW.
Time frame: 1 day
DSC biomarkers
Correlation between DSC (dynamic susceptibility contrast) biomarkers with pathological EGFR-gene amplification status.
Time frame: 1 day
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