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

Phase 2

• Conditions: Head and Neck Cancer
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT02027831
• Lead Sponsor: Jules Bordet Institute

Brief 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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Study First Posted: 2014-01-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-24
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• All patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation).
• Informed consent form signed.

Exclusion Criteria

• Age less than18 years old.
• Inability to give informed consent.
• History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish.
• Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland.
• Documented coronary disease.
• Advanced renal impairment (creatinine > 1,5mg/dl).
• During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin).
• Pregnancy, breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine Green	Indocyanine Green	Intravenous injection of 0,25 mg/kg Indocyanine Green

Primary Outcome Measures

Name	Time	Method
Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection	7 months	After IV injection of Indocyanine Green just before the surgery to head and neck cancer patients, we will study the fluorescence due to ICG in cervical lymph nodes and in the primary lesion.

Trial Locations

Locations (1)

Jules Bordet Institute; 🇧🇪 Brussels, Belgium