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

Exclusion Criteria

• •General:
• •Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the patient to understand and cooperate with the study protocol
• •Deprived of freedom by an administrative or court order or in an emergency setting.
• •Insufficient venous access for the study procedures.
• •Close affiliation with the investigator; e.g. a close relative of the investigator, dependent person (e.g. employee or student), employee of the department of Neurosurgery of the UMCG (University Medical Center Groningen), or affiliates
• •Any finding in the medical examinations or medical history giving, that in the opinion of the investigator, leads to a reasonable suspicion of a disease or condition that makes treatment with the investigational drug unadvisable, or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
• •Participation in an interventional clinical study within 30 days prior to tracer administration that involved treatment with any drug (excluding vitamins and minerals) or medical device
• •Medical conditions
• •Concomitant malignancies, including metastasized colon-, rectal-, breast carcinoma, non-small cellular lung carcinoma (NSCLC); primary epithelial ovarian-, fallopian tube-, primary peritoneal- or cervical carcinoma.
• •Any abnormalities in the vital signs of the patient, as judged by the investigator, as a result of which the patient cannot participate
• •eGFR (based on plasma-creatinine) outside of normal range at screening or known renal impairment (≤40 mL/min).
• •Current evidence or history of bacterial, viral or fungal infections within 7 days before Cetuximab-IRDye800CW administration, as judged by the Investigator.
• •o T \> = 38.0°C or lab confirmed viral/bacterial/fungal infection (PCR)) or symptoms suggestive of an infection)
• •Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be clinically significant
• •A history of anaphylaxis, history of allergic reaction(s), known allergy to one of the drugs or excipients administered as part of this study. Mild allergies without angioedema or treatment need can be acceptable if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever)