IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER (SENTIMAG)

Centre Oscar Lambret

Status

Unknown

Conditions

BREAST CANCER

Treatments

Procedure: Excision of sentinel node(s)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01790399

SENTIMAG-1213

Details and patient eligibility

About

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

Full description

Identification of Sentinel node(s)

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

Step 1: probe SentiMag ® (study) 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

Enrollment

115 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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