Spots Global Cancer Trial Database for Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

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Trial Identification

Brief Title: Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

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.

Study ID: NCT00314405

Conditions

Infiltrative Breast Cancer

Interventions

Methylene blue (1%)

Rhenium sulfure

Surgical procedure

Anatomo-pathologic procedure

Study Description

Brief Summary: 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.

Detailed Description: