Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Infracyanine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infracyanine<br>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). | Drug: Infracyanine<br>* 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).<br>* Other names: indocyanin green;|

What is the study measuring?
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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 | 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. | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time between the incision and removal of the first sentinel node identified |  | During surgery | 
| 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 ) |  | During surgery | 
| 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) |  | During surgery | 
| Technical direct cost |  | during the study | 
| Incidence rates of allergic reactions |  | From screening till 1 month after the surgery | 
| Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 ) |  | From screening till 1 month after the surgery |