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OpenTrials
Completed

NCT Number: NCT00314405

Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.

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Key information

Conditions

Infiltrative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Service de Gynécologie-Obstétrique, Hôpital Civil

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy)
  • approval and informed consent

Exclusion criteria

  • chemotherapy
  • locoregional radiotherapy
  • prevalent axillary lymph node

Treatment and study plan

Methylene blue (1%)

Drug

Rhenium sulfure

Drug

Surgical Procedure

Procedure

Anatomo-pathologic procedure

Procedure

Primary outcomes

  1. Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.

Secondary outcomes

  1. Comparison of the results of SLN serial sectioning, with H&E and IHC staining

  2. Economical evaluation of SLN procedure.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Apr 13, 2006
Registry last updated
Jun 8, 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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