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

Free University of Brussels (ULB)

Status and phase

Unknown

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: Indocyanine Green

Study type

Interventional

Funder types

Other

Identifiers

NCT02027831

HN-ICG-IV

Details and patient eligibility

About

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

Full 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

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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