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Trial Title:
NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG
NCT ID:
NCT02027831
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
lymph nodes
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Indocyanine Green
Arm group label:
Indocyanine Green
Other name:
ICG
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
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
Criteria for eligibility:
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.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jules Bordet Institute
Address:
City:
Brussels
Zip:
1000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Antoine Digonnet, MD
Phone:
003225413319
Email:
antoine.digonnet@bordet.be
Contact backup:
Last name:
Pierre Bourgeois, MD
Phone:
003225413276
Email:
pierre.bourgeois@bordet.be
Investigator:
Last name:
Antoine Digonnet, MD
Email:
Principal Investigator
Start date:
December 2013
Completion date:
October 2014
Lead sponsor:
Agency:
Jules Bordet Institute
Agency class:
Other
Source:
Jules Bordet Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02027831
