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

Sponsor:	Centre Paul Strauss
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00052676

Purpose

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

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Active Control
Official Title:	French Randomized Sentinel Node Multicentric Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Nuclear Scans

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00052676

Locations

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

Sponsors and Collaborators

Centre Paul Strauss

Investigators

Study Chair:

Jean-Francois Rodier, MD

Centre Paul Strauss

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000258612, STRAUSS-FRANSENOD, EU-20214
Study First Received:	January 24, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00052676 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009