The purpose of this study is to determine the safety, optimal dose and imaging time of the investigational product, IRDye800CW-nimotuzumab for use as a near infrared imaging probe for image-guided surgery during lung cancer resection. IRDye800CW-nimotuzumab targets cancer cells over-expressing EGFR, allowing tumors to be visualized and may help surgeons better identify cancer during surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
RECRUITINGPhase 1: Optimal dose of IRDye800CW-nimotuzumab for image guided surgery.
To identify the dose with the highest tumor fluorescence and TBR.
Time frame: up to 14 days
Phase 2: Determine the optimal time for IRDye800CW-nimotuzumab infusion for image guided surgery.
To identify the imaging time with the highest tumor fluorescence and TBR.
Time frame: up to 14 days
Determine primary tumor margins.
Determine the level of fluorescence that can discriminate between EGFR positive tumor tissue and normal tissue.
Time frame: up to 14 days
Identify EGFR positive lymph nodes.
Determine the level of fluorescence that can discriminate between EGFR positive lymph nodes and normal tissue.
Time frame: up to 14 days
Safety of IRDye800CW-nimotuzumab
a. Safety will be determined by recording the number of grade 2 or higher adverse events determined to be clinically significant, which are definitely, probably, or possibly related to IRDye800CW-nimotuzumab within 30 days of administration.
Time frame: up to 14 days
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