Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT00314405
• Collaborator: (none)
• Enrollment: 100
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infiltrative Breast Cancer	Drug: Methylene blue (1%); Drug: Rhenium sulfure; Procedure: Surgical procedure; Procedure: Anatomo-pathologic procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection. []

Secondary Outcome Measures

1. Comparison of the results of SLN serial sectioning, with H&E and IHC staining []

2. Economical evaluation of SLN procedure. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Gynécologie-Obstétrique, Hôpital Civil	Strasbourg		France	67091

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

• Study Director: Jean-Pierre Bellocq, MD, Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00314405
• Other Study ID Numbers: 3157
• First Posted: Apr 13, 2006
• Last Update Posted: Aug 8, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: sentinel lymph node; SLN; probe; breast cancer; lymphoscintigraphy; methylene blue dye
• Additional relevant MeSH terms: Breast Neoplasms; Methylene Blue

Study Results

No Results Posted as of Aug 8, 2008