INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- The Netherlands Cancer Institute
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- tumour visualization by means of c-MET targeted fluores-cence imaging
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
tumour visualization by means of c-MET targeted fluores-cence imaging
Time Frame: peri-operative
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.
Secondary Outcomes
- Lymph node visualization by means of c-MET targeted fluores-cence imaging(peri-operative)
- Dysplasia or Cis by means of c-MET targeted fluores-cence imaging(Peri-operative)