In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.

Inclusion Criteria:

• Written informed consent, prior to performing any protocol related procedures.
• Age ≥ 18 years at time of study entry.
• ≥ T1 penile or tongue squamous cell cancer
• Scheduled for surgical primary tumour resection

Exclusion Criteria:

• Involvement in the planning and/or conduct of the study.
• Pregnant woman
• Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.
• Severe kidney insufficiency

Patients with tongue cancer scheduled for primary tumour resection OR Patients with penile cancer scheduled for primary tumour resection.