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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-13

Study Completion Date

2020-11-14

Brief Summary

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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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Detailed Description

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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.

Conditions

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Head and Neck Cancer Penile Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No