Head and Neck CancerPhase 2NCT02027831
NIR Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After iv Injection of ICG
A Phase 2 study testing Indocyanine Green in people with Head and Neck Cancer, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jules Bordet Institute
Brussels, Brussels Capital, 1000
Antoine Digonnet, MD, 003225413319, antoine.digonnet@bordet.be
Pierre Bourgeois, MD, 003225413276, pierre.bourgeois@bordet.be
About this study
Official title: Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)
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
- Conditions
- Head and Neck Cancer
- Being tested
- Indocyanine Green
- Keywords
- lymph nodes
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green | Experimental | Intravenous injection of 0,25 mg/kg Indocyanine Green Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Digonnet, MD, Principal investigator, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027831
- Sponsor's protocol ID
- HN-ICG-IV
- Status last verified
- Jul 2014
- First submitted
- 2 Jan 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Fluorescence Imaging During Neck Dissection in Head and Neck Cancer Patients After Intravenous Injection of Indocyanine Green (a Feasibility Study)
- ClinicalTrials.gov ID
- NCT02027831
- Acronym / sponsor ID
- HN-ICG-IV
- Conditions
- Head and Neck Cancer
- Keywords
- lymph nodes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green | Experimental | Drug: Indocyanine GreenIntravenous injection of 0,25 mg/kg Indocyanine Green |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine GreenAlso: ICG | Drug | Indocyanine Green |
Primary outcome
Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection
Time frame: 7 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Digonnet, MD principal investigator
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine Green in people with Head and Neck Cancer, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the capacity of ICG to detect cervical lymph nodes after IV injection (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.