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OpenTrials
Completed

NCT Number: NCT04574427

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

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

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Key information

Conditions

Head and Neck Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Penile Cancer Penile Diseases Penile Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Netherlands Cancer Institute / Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Acronym: INFLUENCE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2020
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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