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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052676
First received: January 24, 2003
Last updated: May 14, 2013
Last verified: September 2007

January 24, 2003
May 14, 2013
October 2002
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Complete list of historical versions of study NCT00052676 on ClinicalTrials.gov Archive Site
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Technetium Tc 99m Sulfur Colloid and Blue Dye In Detecting Sentinel Lymph Nodes in Patients With Breast Cancer
French Randomized Sentinel Node Multicentric Study

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.

OBJECTIVES:

  • 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.

Interventional
Not Provided
Allocation: Randomized
Primary Purpose: Diagnostic
Breast Cancer
  • Drug: patent blue V dye
  • Procedure: radionuclide imaging
  • Procedure: sentinel lymph node biopsy
  • Radiation: technetium Tc 99m sulfur colloid
Not Provided
Rodier JF, Velten M, Wilt M, Martel P, Ferron G, Vaini-Elies V, Mignotte H, Bremond A, Classe JM, Dravet F, Routiot T, de Lara CT, Avril A, Lorimier G, Fondrinier E, Houvenaeghel G, Avigdor S. Prospective multicentric randomized study comparing periareolar and peritumoral injection of radiotracer and blue dye for the detection of sentinel lymph node in breast sparing procedures: FRANSENODE trial. J Clin Oncol. 2007 Aug 20;25(24):3664-9. Epub 2007 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
May 2007
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Over 18

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • No prior surgery for cancer

Other

  • No prior neoadjuvant treatment for cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00052676
STRAUSS-FRANSENOD, CDR0000258612, EU-20214
Not Provided
Not Provided
Centre Paul Strauss
Not Provided
Study Chair: Jean-Francois Rodier, MD Centre Paul Strauss
National Cancer Institute (NCI)
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP