Sentinel Lymph Node Technique in Multifocal Breast Cancer (IGASSU)

March 12, 2026 updated by: Centre Oscar Lambret

Interest of Sentinel Lymph Node Technique in Women With a Multifocal Breast Cancer - IGASSU-0502

The scope of this trial is to assess the Sentinel Lymph Node Technique in Multifocal Breast Cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The sentinel lymph node is located preferentially by:

  • association of subareolar injection of technecium and blue dye
  • or, in case of blue dye allergy, by the subareolar injection of technecium only
  • or, in case of no possibility of radioactive isotope subareolar injection , by blue dye injection only This procedures are made the day before the surgery or the day of the surgery
  • This procedure is immediately follows by complete axillary dissection during breast surgery
  • The anatomopathologic analysis of the 2 samples (sentinel lymph node and axillary dissection) and the histologic confirmation on the removed tumor of the multifocal nature of the breast cancer correspond to the end of the study for the patient.

Study Type

Interventional

Enrollment (Actual)

216

Phase

  • Phase 2

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
      • Amiens, France, 80054
        • Centre Hospitalier Universitaire
      • Angers, France, 49933
        • Centre Paul Papin
      • Bordeaux, France, 33076
        • Institut Bergonié
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Coudekerque-Branche, France, 59210
        • Clinique de Flandre
      • Dijon, France, 21000
        • Centre Georges-Francois LECLERCQ
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Leon Berard
      • Marseille, France, 130009
        • Institut Paoli Calmettes
      • Montpellier, France, 34298
        • CRLC Val d'Aurelle
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75010
        • Hopital Lariboisiere
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint-Herblain, France, 44805
        • Centre René Gauducheau
      • Saint-Julien-en-Genevois, France, 74167
        • Centre Hospitalier Sud Léman Valsérine
      • Thonon-les-Bains, France, 74203
        • Hôpital Georges PIANTA
      • Toulouse, France, 31052
        • Centre Claudius Regaud
      • Valenciennes, France, 59300
        • Centre hospitalier
      • Villejuif, France, 94808
        • Institut Gustave Roussy

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

Description

Inclusion Criteria:

  • Multifocal invasive breast cancer
  • At least 2 focuses (clinically and/or by mammography or ultrasound)
  • Proven by pre-surgical histology (on 1 focus at least)
  • Age > 18 years old
  • Clinically negative axillary lymph nodes
  • No treatment before surgery
  • Signature of written informed consent

Exclusion Criteria:

  • Multifocality proven after surgery
  • Non invasive breast cancer
  • Inflammatory breast cancer
  • Axillary lymph node
  • Metastatic disease
  • Previous homolateral breast cancer
  • Dementia or alterated mental status
  • Pregnant or lactating woman

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
detection rate of sentinel nodes
Time Frame: surgery
surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
number of sentinel nodes removed
Time Frame: surgery
surgery
localisation of the sentinel nodes
Time Frame: surgery
surgery

Collaborators and Investigators

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

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: GIARD Sylvia, MD, 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 (Actual)

March 1, 2006

Primary Completion (Actual)

August 13, 2010

Study Completion (Actual)

August 13, 2010

Study Registration Dates

First Submitted

December 29, 2006

First Submitted That Met QC Criteria

December 29, 2006

First Posted (Estimated)

January 1, 2007

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGASSU-0502

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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