Imaging of tumoral tissues and of lymph nodes to be resected in head and neck cancers
Conditions
Interventions
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: - 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 ;Primary end point(s): 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;Timepoint(s) of evaluation of this end point: after the surgery and the pathlogical diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 ;Timepoint(s) of evaluation of this end point: after the surgery and the pathological diagnosis | — |
Countries
Belgium
Contacts
Public ContactProf Pierre Bourgeois
Institut Jules Bordet
Outcome results
None listed