This trial is active, not recruiting.

Condition breast cancer
Treatment excision of sentinel node(s)
Sponsor Centre Oscar Lambret
Collaborator Sysmex America, Inc.
Start date January 2013
End date February 2014
Trial size 115 participants
Trial identifier NCT01790399, SENTIMAG-1213


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
excision of sentinel node(s)
Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)

Primary Outcomes

Sentinel node(s)detected with new technical
time frame: The day of surgery

Secondary Outcomes

Detected node(s) for each method(standard and new)
time frame: The day of surgery

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Centre Oscar Lambret.