Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00314405

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Methylene blue

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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.

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

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

Keywords provided by University Hospital, Strasbourg, France:

sentinel lymph node
SLN
probe

breast cancer
lymphoscintigraphy
methylene blue dye

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Methylene Blue
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009