Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Infiltrative Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314405
• Other study ID #: 3157
• Status: Completed
• Phase: N/A
• First received: April 11, 2006
• Last updated: August 7, 2008
• Start date: April 2006

Study information

• Verified date: February 2008
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Infiltrative Breast Cancer

Intervention

Drug:
• Methylene blue (1%)

• Rhenium sulfure

Procedure:
• Surgical procedure

• Anatomo-pathologic procedure

Locations

Country	Name	City	State
France	Service de Gynécologie-Obstétrique, Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
Secondary	Comparison of the results of SLN serial sectioning, with H&E and IHC staining
Secondary	Economical evaluation of SLN procedure.