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Status unknownNCT02027831Updated Jul 24, 2014

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

A Phase 2 interventional study of Indocyanine Green in Head and Neck Cancer, sponsored by Jules Bordet Institute. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-24.

Sponsored by Jules Bordet Institute · Phase 2, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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
02

Conditions studied

  • Head and Neck Cancer

Keywords

  • lymph nodes
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 10 is below the median of 47 across 1,751 interventional studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Indocyanine Green

    Intravenous injection of 0,25 mg/kg Indocyanine Green

    Drug: Indocyanine Green

Interventions

  • DrugIndocyanine Green

    Also known as: ICG

06

What researchers measure

Primary outcomes

  1. Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection

    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.

    Time frame: 7 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02027831
Lead sponsor
Jules Bordet Institute
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Dec 2013
Primary completion
Oct 2014 (estimated)
Completion
Oct 2014 (estimated)
Last update
Jul 24, 2014

Study contacts

Antoine Digonnet, MD
principal investigator · Jules Bordet Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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