BREAST CANCER
Conditions
Keywords
SENTINEL NODE
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
Interventions
PROCEDUREExcision of sentinel node(s)
Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)
Sponsors
Sysmex America, Inc.
Centre Oscar Lambret
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Detected node(s) for each method(standard and new) | The day of surgery | Proportion of detected nodes for each method(standard and new) |
Countries
France
Outcome results
None listed