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NCT04574427 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— INFLUENCE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04574427
Other study ID # N19IFC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 13, 2019
Est. completion date November 14, 2020

Study information
Verified date October 2022
Source The Netherlands Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date November 14, 2020
Est. primary completion date November 13, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands The Netherlands Cancer Institute / Antoni van Leeuwenhoek Amsterdam Noord-Holland

Sponsors (1)
Lead Sponsor Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. peri-operative
Secondary 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 peri-operative
Secondary Dysplasia or Cis by means of c-MET targeted fluores-cence imaging Identification of dysplasia or carcinoma in situ in penile and tongue tumours. Peri-operative
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