Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope
June 5, 2026 updated by: University Hospital, Strasbourg, France
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.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Service de Gynécologie-Obstétrique, Hôpital Civil
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
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Secondary Outcome Measures
Outcome Measure |
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Comparison of the results of SLN serial sectioning, with H&E and IHC staining
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Economical evaluation of SLN procedure.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jean-Pierre Bellocq, MD, Hopitaux Universitaires de Strasbourg
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
April 11, 2006
First Submitted That Met QC Criteria
April 11, 2006
First Posted (Estimated)
April 13, 2006
Study Record Updates
Last Update Posted (Actual)
June 8, 2026
Last Update Submitted That Met QC Criteria
June 5, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3157
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