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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04574427
Study type Observational
Source The Netherlands Cancer Institute
Contact
Status Completed
Phase
Start date November 13, 2019
Completion date November 14, 2020
View Details
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