IDENTIFICATION OF SENTINEL NODE(S) IN BREAST CANCER

BREAST CANCER Clinical Trial

— SENTIMAG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01790399
• Other study ID #: SENTIMAG-1213
• Status: Active, not recruiting
• Phase: N/A
• First received: February 8, 2013
• Last updated: March 5, 2014
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2013
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 115
• Est. completion date: July 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• BREAST CANCER
• Breast Neoplasms

Intervention

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)

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Centre Eugène Marquis	Rennes
France	Institut Claudius Regaud	Toulouse
France	Centre Alexis Vautrin	Vandoeuvre les nancy

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Sysmex America, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel node(s)detected with new technical	Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)	The day of surgery	Yes
Secondary	Detected node(s) for each method(standard and new)	Proportion of detected nodes for each method(standard and new)	The day of surgery	Yes