IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-07-31

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

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Detailed Description

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* 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

Conditions

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BREAST CANCER

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Identification of sentinel node(s)

Group Type EXPERIMENTAL

Excision of sentinel node(s)

Intervention Type PROCEDURE

Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)

Interventions

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Excision of sentinel node(s)

Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No