IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
18 Years
N/A
Female
BREAST CANCER
Trial Information
IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY
- 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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Sentinel node(s)detected with new technical
Outcome Description:
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
Outcome Time Frame:
The day of surgery
Safety Issue:
Yes
Principal Investigator
Jean-Louis MD HOUPEAU
Investigator Role:
Study Director
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
SENTIMAG-1213
NCT ID:
NCT01790399
Start Date:
January 2013
Completion Date:
October 2013
Related Keywords:
- Breast Cancer
- SENTINEL NODE
- Breast Neoplasms
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