Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope
- Conditions
- Infiltrative Breast Cancer
- Registration Number
- NCT00314405
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- patients with infiltrative breast cancer (diagnosed pre-operatively by core biopsy)
- approval and informed consent
- chemotherapy
- locoregional radiotherapy
- prevalent axillary lymph node
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
- Secondary Outcome Measures
Name Time Method Comparison of the results of SLN serial sectioning, with H&E and IHC staining Economical evaluation of SLN procedure.
Trial Locations
- Locations (1)
Service de Gynécologie-Obstétrique, Hôpital Civil
🇫🇷Strasbourg, France
Service de Gynécologie-Obstétrique, Hôpital Civil🇫🇷Strasbourg, France