Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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

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Conditions

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Infiltrative Breast Cancer

Keywords

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sentinel lymph node SLN probe breast cancer lymphoscintigraphy methylene blue dye

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Methylene blue (1%)

Intervention Type DRUG

Rhenium sulfure

Intervention Type DRUG

Surgical procedure

Intervention Type PROCEDURE

Anatomo-pathologic procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Pierre Bellocq, MD

Role: STUDY_DIRECTOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Gynécologie-Obstétrique, Hôpital Civil

Strasbourg, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT

PMID: 19846959 (View on PubMed)

Other Identifiers

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3157

Identifier Type: -

Identifier Source: org_study_id