INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue (INFLUENCE)

Netherlands Cancer Institute (NKI)

Status: Completed

Conditions: Penile Cancer; Head and Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04574427

N19IFC

Details and patient eligibility

About

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

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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