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NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG

Head and Neck Cancer Clinical Trial

Official title:
Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)

Clinical Trial Summary

The purpose of this study is to determine if NIR fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour

Clinical Trial Description

Primary objective:

definition of the distribution of intravenously injected ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients or in nodes recurrences in head and neck cancer

Secondary objectives:

- Evaluation of the ability of NIR fluorescence imaging to determine the tumoral volume, specifically the margins of the tumoral tissues (in the operating room and in the pathology department)

- Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes ;

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02027831
Study type Interventional
Source Jules Bordet Institute
Contact
Status Recruiting
Phase Phase 2
Start date December 2013
Completion date October 2014
View Details
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