Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer
July 2, 2019 updated by: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)
This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.
Study Overview
Detailed Description
Visits:
Screening:
Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.
Intervention:
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.
- All radioactive nodes and / or fluorescent will be deleted
- Reports of anatomy fluorescent SN and / or hot
Next visit:
The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75015
- Hôpital Européen Georges Pompidou
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female age > 18 years
- Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
- Diagnosis confirmed by biopsy
- Breast cancer extended in situ
- First surgical treatment
Exclusion Criteria:
- Neoadjuvant chemotherapy or hormone therapy.
- Multicentric tumor
- Pregnant patient
- Ongoing participation in another clinical trial with an investigational drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Infracyanine
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
|
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient
Time Frame: During surgery
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The detection rate is defined by the number of patient who at least one axillary sentinel node detected by fluorescence and / or isotope intraoperatively / number of female patients injected.
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During surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The time between the incision and removal of the first sentinel node identified
Time Frame: During surgery
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During surgery
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The sensitivity of indocyanine green compared to the technical reference ( percentage of nodes detected by the isotope and which are also detected by the indocyanine green )
Time Frame: During surgery
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During surgery
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The wrong negative rate (number of female patients in whom at least one metastatic sentinel node has been detected by isotope and not by ICG)
Time Frame: During surgery
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During surgery
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Technical direct cost
Time Frame: during the study
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during the study
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Incidence rates of allergic reactions
Time Frame: From screening till 1 month after the surgery
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From screening till 1 month after the surgery
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Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )
Time Frame: From screening till 1 month after the surgery
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From screening till 1 month after the surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Charlotte NGO, MD, Hôpital Européen Georges-Pompidou
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
March 1, 2019
Study Registration Dates
First Submitted
August 18, 2016
First Submitted That Met QC Criteria
August 22, 2016
First Posted (Estimate)
August 23, 2016
Study Record Updates
Last Update Posted (Actual)
July 5, 2019
Last Update Submitted That Met QC Criteria
July 2, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLUOBREAST
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.