This is a two-staged clinical trial to investigate the feasibility of intraoperative Fluorescence Imaging (FLI) to adequately assess tumor margins in patients with oral cancer using cRGD-ZW800-1.
Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
≥ 18 years of age;
Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
Screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant.
Previous surgery, chemotherapy or radiotherapy to the oral cavity;
History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
Patients with renal insufficiency (eGFR<60);