Study to evaluate if the surgeon find more cervical lymph nodes after injection around the tumor of a fluorescent molecule (Indocyanine Green) in patients with head and neck cancer

Near-Infrared fluorescence imaging during neck dissection in head and neck cancer patients after peritumoral injection of Indocyanine Green (a feasibility study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000298-37-BE

Enrollment

Registered

2014-09-25

Start date

2014-10-20

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: ICG Pulsion Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Indocyanine Green CAS Number: 3599-32-4 Current Sponsor code: HN-ICG-LN-1 Other descriptive name: IN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - All patients requiring neck dissection with 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: Evaluation of our ability to define per-operatively using NIR camera device the distribution of peritumoraly injected free ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients. ;Secondary Objective: - Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes - Evaluation of the impact of NIR fluorescence on lymph nodes yield during neck dissection. - Evaluation of the impact of NIR fluorescence on lymph nodes yield during analysis of the piece in the service of pathology ;Primary end point(s): Evaluation of our ability to define per-operatively using NIR camera device the distribution of peritumoraly injected free ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients. ;Timepoint(s) of evaluation of this end point: after the surgery and the pathlogical diagnosis	—

Measure

Time frame

Main Objective: Evaluation of our ability to define per-operatively using NIR camera device the distribution of peritumoraly injected free ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients. ;Secondary Objective: - Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes - Evaluation of the impact of NIR fluorescence on lymph nodes yield during neck dissection. - Evaluation of the impact of NIR fluorescence on lymph nodes yield during analysis of the piece in the service of pathology ;Primary end point(s): Evaluation of our ability to define per-operatively using NIR camera device the distribution of peritumoraly injected free ICG in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients. ;Timepoint(s) of evaluation of this end point: after the surgery and the pathlogical diagnosis

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Secondary

Measure	Time frame
Secondary end point(s): - Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes - Evaluation of the impact of NIR fluorescence on lymph nodes yield during neck dissection. - Evaluation of the impact of NIR fluorescence on lymph nodes yield during analysis of the piece in the service of pathology ;Timepoint(s) of evaluation of this end point: after the surgery and the pathlogical diagnosis	—

Measure

Time frame

Secondary end point(s): - Analysis of the correlation between ICG fluorescence and tumoral invasion in the dissected lymph nodes - Evaluation of the impact of NIR fluorescence on lymph nodes yield during neck dissection. - Evaluation of the impact of NIR fluorescence on lymph nodes yield during analysis of the piece in the service of pathology ;Timepoint(s) of evaluation of this end point: after the surgery and the pathlogical diagnosis

—

Countries

Belgium

Contacts

Public ContactProf Pierre Bourgeois

Jules Bordet Institute

pierre.bourgeois@bordet.be003225413276

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026