Back to resultsNIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring lymph nodes
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
Sites / Locations
- Jules Bordet InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Indocyanine Green
Arm Description
Intravenous injection of 0,25 mg/kg Indocyanine Green
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02027831
Brief Title
NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG
Official Title
Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jules Bordet Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
lymph nodes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Indocyanine Green
Arm Type
Experimental
Arm Description
Intravenous injection of 0,25 mg/kg Indocyanine Green
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Primary Outcome Measure Information:
Title
Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Digonnet, MD
Organizational Affiliation
Jules Bordet Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jules Bordet Institute
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Digonnet, MD
Phone
003225413319
Email
antoine.digonnet@bordet.be
First Name & Middle Initial & Last Name & Degree
Pierre Bourgeois, MD
Phone
003225413276
Email
pierre.bourgeois@bordet.be
First Name & Middle Initial & Last Name & Degree
Antoine Digonnet, MD
12. IPD Sharing Statement
Learn more about this trial
NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG
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