INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue (INFLUENCE)
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ClinicalTrials.gov Identifier: NCT04574427
Recruitment Status :
(Tracer not available.)
In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.
Condition or disease
Head and Neck CancerPenile Cancer
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.
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 Outcome Measures :
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
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with tongue cancer scheduled for primary tumour resection OR Patients with penile cancer scheduled for primary tumour resection.
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
Involvement in the planning and/or conduct of the study.
Abstaining from usage of two forms of barrier contraceptive or actively planning pregnancy within 90 days.