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)

  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

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

Identification of sentinel node(s)

Experimental group

Treatment:

Procedure: Excision of sentinel node(s)