Imaging of head and neck tumors and their associated lymph nodes after intravenous injection of Indocyanine Green, a fluorescent molecule.

• Register: EUCTR
• Last refreshed on: 7 October 2014
• Main ID: EUCTR2013-004498-29-BE
• Date of registration: 08/11/2013
• Prospective Registration: Yes
• Primary sponsor: Institut Jules Bordet
• Public title: Imaging of head and neck tumors and their associated lymph nodes after intravenous injection of Indocyanine Green, a fluorescent molecule.
• Scientific title: Near-Infrared fluorescence imaging during neck dissection in head and neck cancer patients after intravenous injection of Indocyanine Green (a feasibility study)
• Date of first enrolment: 29/11/2013
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004498-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium

Contacts

• Name: Prof Pierre Bourgeois
• Affiliation: Institut Jules Bordet

• Name: Prof Pierre Bourgeois
• Affiliation: Institut Jules Bordet

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Imaging of tumoral tissues and of lymph nodes to be resected in head and neck cancers

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Indocyanine Green PULSION 25mg
Pharmaceutical Form: Powder for solution for injection

Primary Outcome(s)

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 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

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 Outcome(s)

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

Secondary ID(s)

HN-ICG-IV-1

Source(s) of Monetary Support

Institut Jules Bordet