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

March 5, 2014 updated by: Centre Oscar Lambret

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Toulouse, France, 31 052
        • Institut Claudius Regaud
      • Vandoeuvre les nancy, France, 54 511
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Identification of sentinel node(s)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sentinel node(s)detected with new technical
Time Frame: The day of surgery
Idenfication 's rate of sentinel nodes detected with new technical(SentiMag ® / Sienna + TM)
The day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detected node(s) for each method(standard and new)
Time Frame: The day of surgery
Proportion of detected nodes for each method(standard and new)
The day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Sysmex America, Inc.

Investigators

  • Study Director: Jean-Louis MD HOUPEAU, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ANTICIPATED)

July 1, 2014

Study Registration Dates

First Submitted

February 8, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (ESTIMATE)

February 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENTIMAG-1213

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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