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

Completed

• Conditions: Head and Neck Cancer; Penile Cancer

• Registration Number: NCT04574427
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-10-05
• Primary Completion: 2020-11-13
• Study Completion: 2020-11-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tumour visualization by means of c-MET targeted fluores-cence imaging	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 Outcome Measures

Name	Time	Method
Lymph node visualization by means of c-MET targeted fluores-cence imaging	peri-operative	Detection and visualization of lymph node metastases in penile and tongue tumour patients
Dysplasia or Cis by means of c-MET targeted fluores-cence imaging	Peri-operative	Identification of dysplasia or carcinoma in situ in penile and tongue tumours.

Trial Locations

Locations (1)

The Netherlands Cancer Institute / Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, Noord-Holland, Netherlands