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.
Infiltrative Breast Cancer
Drug: Methylene blue (1%)
Drug: Rhenium sulfure
Procedure: Surgical procedure
Procedure: Anatomo-pathologic procedure
|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.|
- Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
- Comparison of the results of SLN serial sectioning, with H&E and IHC staining
- Economical evaluation of SLN procedure.
|Study Start Date:||April 2006|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314405
|Service de Gynécologie-Obstétrique, Hôpital Civil|
|Strasbourg, France, 67091|
|Study Director:||Jean-Pierre Bellocq, MD||Hôpitaux Universitaires de Strasbourg|