IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

Study Overview
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Brief Summary
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The study is based on the identification of sentinel node(s) by SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product). This is a feasibility study

Detailed Description
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Identification of Sentinel node(s) Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery Step 2: Identification using the technique SentiMag ® / Sienna+ Injection Sienna + ™ should be done just after induction of anesthesia and before the injection of Patent Blue dye Step 3: Identification using the technique of Patent Blue Dye or Lymphotropic dye injection or Patent Blue is performed after induction of anesthesia, the injection and production Sienna + ™, the operating theater by the surgeon Detection of Sentinel node(s) Step 1: probe SentiMag ® (study) Step 2: hand probe gamma radiation detection and / or colorimetric detection (standard) Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown) After the procedure: Characterization of the size and weight of lymph nodes, histological and / or molecular OSNA and linking nodal status with the detection rate of sentinel nodes for each technique. NB: In case of synchronous bilateral cancer, 2 records are possible

Official Title
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IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY

Conditions
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BREAST CANCER

Intervention / Treatment
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* Procedure: Excision of sentinel node(s)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with invasive breast cancer or microinfiltrant proven by cytology and histo-or whatever the histological type cT0/cT1/cT2 (up to 5 cm) CN0 clinical and / or ultrasound and without prior treatment (chemotherapy or neoadjuvant hormone ) Age greater than or equal to 18 Reporting of breast surgery and axillary staging of sentinel lymph node Using effective contraception (BHCG negative) Patient affiliated with a health insurance Consent signed by the patient Exclusion Criteria: T3 or T4 tumors (> 5 cm, cutaneous or muscle inflammation or cancer) Presence of a clinically suspicious axillary adenopathy or imaging Tumors bifocal or multifocal known before Surgery History of breast surgery or axillary Patient metastatic Patient with a cons-indication anesthesia and / or surgery Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to Patent blue dye in centers where it is commonly used Patient can not receive a radioactive isotope to the sentinel lymph node resection Allergy radioactive product Chronic iron overload Pacemaker or other implantable device in the chest wall Failure to submit to medical study for geographical, social or psychological Patient deprived of liberty or under guardianship Pregnant or lactating

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: Identification of sentinel node(s)<br> | Procedure: Excision of sentinel node(s)<br>* Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel node(s)detected with new technical | Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM) | The day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detected node(s) for each method(standard and new) | Proportion of detected nodes for each method(standard and new) | The day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SENTINEL NODE