Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

University Hospital, Strasbourg, France

Status: Completed

Conditions: Infiltrative Breast Cancer

Treatments: Drug: Rhenium sulfure; Procedure: Anatomo-pathologic procedure; Procedure: Surgical procedure; Drug: Methylene blue (1%)

Study type: Interventional

Funder types: Other

Identifiers

NCT00314405

3157

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)