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

The Netherlands Cancer Institute5 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer Penile Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Netherlands Cancer Institute / Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

tumour visualization by means of c-MET targeted fluores-cence imaging

The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.

Time frame: peri-operative

Secondary Outcomes

Lymph node visualization by means of c-MET targeted fluores-cence imaging

Detection and visualization of lymph node metastases in penile and tongue tumour patients

Time frame: peri-operative

Dysplasia or Cis by means of c-MET targeted fluores-cence imaging

Identification of dysplasia or carcinoma in situ in penile and tongue tumours.

Time frame: Peri-operative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.