NCT02027831

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Indocyanine Green

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-01-06
• Last updated: 2014-07-24

Locations

1 site across 1 country: Belgium