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

October 18, 2022 updated by: The Netherlands Cancer Institute
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066CX
        • The Netherlands Cancer Institute / Antoni van Leeuwenhoek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with tongue cancer scheduled for primary tumour resection OR Patients with penile cancer scheduled for primary tumour resection.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
peri-operative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Baris Karakullukcu, MD, PhD, The Netherlands Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2019

Primary Completion (Actual)

November 13, 2020

Study Completion (Actual)

November 14, 2020

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 28, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N19IFC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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