Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314405

Enrollment

100

Registered

2006-04-13

Start date

2006-04-01

Completion date

2008-04-01

Last updated

2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infiltrative Breast Cancer

Keywords

sentinel lymph node, SLN, probe, breast cancer, lymphoscintigraphy, methylene blue dye

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.

Interventions

DRUGMethylene blue (1%)

DRUGRhenium sulfure

PROCEDURESurgical procedure

PROCEDUREAnatomo-pathologic procedure

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.	—

Secondary

Measure	Time frame
Comparison of the results of SLN serial sectioning, with H&E and IHC staining	—
Economical evaluation of SLN procedure.	—

Countries

France

Contacts

STUDY_DIRECTORJean-Pierre Bellocq, MD

Hôpitaux Universitaires de Strasbourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026