NCT01790399

IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• BREAST CANCER

Interventions

Type	Name	Description
PROCEDURE	Excision of sentinel node(s)	Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-02-01
• Completion: 2014-07-01
• First posted: 2013-02-13
• Last updated: 2014-03-06

Locations

4 sites across 1 country: France