IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

Not Applicable

• Conditions: BREAST CANCER
• Interventions: Procedure: Excision of sentinel node(s)

• Registration Number: NCT01790399
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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

* Identification of Sentinel node(s)

1. Step 1: Identification using the technique Nanocis Sub-areolar injection of Tc99m-Nanocis ® the day before or the day of surgery

2. 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

3. 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)

1. Step 1: probe SentiMag ® (study)

2. 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

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Status Verified: 2013-08
• Primary Completion: 2014-02
• Last Update Submitted: 2014-03-05
• Last Update Posted: 2014-03-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 115

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Identification of sentinel node(s)	Excision of sentinel node(s)	-

Primary Outcome Measures

Name	Time	Method
Sentinel node(s)detected with new technical	The day of surgery	Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)

Secondary Outcome Measures

Name	Time	Method
Detected node(s) for each method(standard and new)	The day of surgery	Proportion of detected nodes for each method(standard and new)

Trial Locations

Locations (4)

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre Alexis Vautrin; 🇫🇷 Vandoeuvre les nancy, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France