Fluorescence-guided Surgery Using cRGD-ZW800-1 in Oral Cancer

Work package I:

In WP-I, the preferred dose of the agent for imaging of margins in oral cancer will be determined. The signal-to-noise ratio will be determined in dose group A (n=7), which will receive 0.05 mg/kg of the tracer, 16-20 hours before surgery. After an interim evaluation of this ratio, the second dose group B (n=7) will receive either a higher or a lower dosage (to be determined) of the tracer. After inclusion of all patients (n=14), the dose with the highest intraoperative signal-to-noise ratio will be selected.

Work package II:

In WP-II, an expansion cohort (n=14) will be added to the group of patients that had received the selected dose in WP-I. In this group of 21 patients, it will be determined if FLI can improve the rate of adequate surgical resection margins. As secondary research questions, the following aspects will be assessed:

• sensitivity, specificity, positive and negative predictive values of FLI;
• colocalization with immunohistochemistry;
• change in surgical management; incremental operation time;
• FLI of excised cervical lymph nodes.

Inclusion criteria

• 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.

Exclusion criteria

• 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);
• Patients with a previous kidney transplantation in the medical history;
• Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
• Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.