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

Netherlands Cancer Institute (NKI) logo

Netherlands Cancer Institute (NKI)

Status

Completed

Conditions

Penile Cancer
Head and Neck Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04574427
N19IFC

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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