Identification of Sentinel Lymph Nodes With Methylene Blu... | NCT00314405

Studies
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

NCT00314405

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Jun 8, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Infiltrative Breast Cancer

Interventions

Methylene blue (1%)
Rhenium sulfure
Surgical procedure
Anatomo-pathologic procedure

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2008Actual

First Submitted Date

Apr 11, 2006

First Submission Date that Met QC Criteria

Apr 11, 2006

First Posted Date

Apr 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2026

Last Update Posted Date

Jun 8, 2026Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Pierre Bellocq, MD	Hôpitaux Universitaires de Strasbourg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Gynécologie-Obstétrique, Hôpital Civil		Strasbourg		67091	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19846959	Result	Mathelin C, Croce S, Brasse D, Gairard B, Gharbi M, Andriamisandratsoa N, Bekaert V, Francis Z, Guyonnet JL, Huss D, Salvador S, Schaeffer R, Grucker D, Marin C, Bellocq JP. Methylene blue dye, an accurate dye for sentinel lymph node identification in early breast cancer. Anticancer Res. 2009 Oct;29(10):4119-25.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D008751	Methylene Blue
D013514	Surgical Procedures, Operative

ID	Term
D010640	Phenothiazines
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006575	Heterocyclic Compounds, 3-Ring

Name	Type	Description	Arm Group Labels	Other Names
Methylene blue (1%)	Drug
Rhenium sulfure	Drug
Surgical procedure	Procedure
Anatomo-pathologic procedure	Procedure