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

BREAST CANCER Clinical Trial

Official title: IDENTIFICATION OF SENTINEL NODE(S) BY SENTIMAG® /SIENNA+ IN BREAST CANCER: FEASIBILITY STUDY

Status Active, not recruiting

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• BREAST CANCER
• Breast Neoplasms

• NCT number: NCT01790399
• Study type: Interventional
• Source: Centre Oscar Lambret
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Completion date: July 2014