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Completed

NCT Number: NCT00417495

Sentinel Lymph Node Technique in Multifocal Breast Cancer

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

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire, Amiens, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sentinel Lymph Node Technique

Behavioral

Primary outcomes

  1. detection rate of sentinel nodes

    Time frame: surgery

Secondary outcomes

  1. number of sentinel nodes removed

    Time frame: surgery

  2. localisation of the sentinel nodes

    Time frame: surgery

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

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

Acronym: IGASSU

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 1, 2007
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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