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Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00314405
First received: April 11, 2006
Last updated: August 7, 2008
Last verified: February 2008
History of Changes
  Purpose

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.


Condition Intervention
Infiltrative Breast Cancer
 Drug: Methylene blue (1%)
Drug: Rhenium sulfure
Procedure: Surgical procedure
Procedure: Anatomo-pathologic procedure

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.

Secondary Outcome Measures:
  • Comparison of the results of SLN serial sectioning, with H&E and IHC staining
  • Economical evaluation of SLN procedure.

Estimated Enrollment: 100
Study Start Date: April 2006
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314405

Locations
France
Service de Gynécologie-Obstétrique, Hôpital Civil
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Jean-Pierre Bellocq, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00314405     History of Changes
Other Study ID Numbers: 3157
Study First Received: April 11, 2006
Last Updated: August 7, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
sentinel lymph node
SLN
probe
 breast cancer
lymphoscintigraphy
methylene blue dye

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013