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Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00052676
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2013
Information provided by:

Study Description
Brief Summary:

RATIONALE: It is not yet known whether injecting technetium Tc 99m sulfur colloid and blue dye near the tumor is more effective than injecting them near the nipple in identifying sentinel lymph nodes in patients with stage I or stage II breast cancer.

PURPOSE: Randomized diagnostic trial to compare the effectiveness of injecting technetium Tc 99m sulfur colloid and blue dye near the tumor with that of injections around the nipple in detecting sentinel lymph nodes in patients who have stage I or stage II breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Drug: patent blue V dye Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid

Detailed Description:


  • Determine the optimal mode of injection (peritumoral vs periareolar) of patent blue V dye and technetium Tc 99m sulfur colloid in patients with stage I or II breast cancer undergoing sentinel lymph node identification.
  • Determine the reduction of morbidity associated with breast cancer surgery, in terms of local control and survival, in patients undergoing sentinel lymph node identification with these drugs.
  • Determine the evolution of disease in patients who have undergone this procedure and do not show histological invasion of the sentinel lymph node.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive peritumoral injections of patent blue V dye and technetium Tc 99m sulfur colloid.
  • Arm II: Patients receive periareolar injections as in arm I. Patients in both arms showing histological metastasis of the sentinel lymph node or without identification of the sentinel lymph node undergo standard axillary lymph node dissection.

Patients are followed for disease evolution.

PROJECTED ACCRUAL: A total of 450 patients (225 per arm) will be accrued for this study within 2-2.5 years.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Diagnostic
Official Title: French Randomized Sentinel Node Multicentric Study
Study Start Date : October 2002
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed invasive breast cancer

    • T0, T1, or T2 no greater than 3 cm, N0
    • Amenable to surgery
  • No inflammatory breast cancer
  • No ductal cancer in situ or multicentric invasive ductal cancer
  • No nipple/areola or central breast cancer (at least 2 cm from areola)
  • No metastatic disease
  • Hormone receptor status:

    • Not specified



  • Over 18


  • Not specified

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant
  • Negative pregnancy test
  • No known allergy or intolerance to patent blue V dye


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • No prior surgery for cancer


  • No prior neoadjuvant treatment for cancer
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00052676

Clinique Tivoli
Bordeaux, France, F-33030
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Centre Leon Berard
Lyon, France, 69373
Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, France, 44805
Centre Paul Strauss
Strasbourg, France, 67085
Institut Claudius Regaud
Strasbourg, France, 67085
Sponsors and Collaborators
Centre Paul Strauss
Study Chair: Jean-Francois Rodier, MD Centre Paul Strauss
More Information

ClinicalTrials.gov Identifier: NCT00052676     History of Changes
CDR0000258612 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: September 2007

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Technetium Tc 99m Sulfur Colloid
Molecular Mechanisms of Pharmacological Action