Clinical trial NCT01790399: IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER
Official title: IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BREAST CANCER
Keywords: SENTINEL NODE
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Sysmex America, Inc.
First posted: 2013-02-13
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Sentinel node(s)detected with new technical
timeFrame: The day of surgery
Secondary outcomes:
measure: Detected node(s) for each method(standard and new)
timeFrame: The day of surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Vandoeuvre les nancy
country: France
facility: Centre Alexis Vautrin
Study officials:
affiliation: Centre Oscar Lambret
name: Jean-Louis MD HOUPEAU
role: STUDY_DIRECTOR
References: