NCT00052676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2002

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 15, 2013

Status Verified

September 1, 2007

First QC Date

January 24, 2003

Last Update Submit

May 14, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Interventions

patent blue V dyeDRUG
radionuclide imagingPROCEDURE
sentinel lymph node biopsyPROCEDURE
technetium Tc 99m sulfur colloidRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Clinique Tivoli

Bordeaux, F-33030, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Regional Rene Gauducheau

Nantes-Saint Herblain, 44805, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Institut Claudius Regaud

Strasbourg, 67085, France

Location

Related Publications (1)

  • 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. doi: 10.1200/JCO.2006.08.4228. Epub 2007 May 7.

    PMID: 17485709RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

iso-sulfan blueSentinel Lymph Node BiopsyTechnetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative TechniquesSulfur CompoundsInorganic ChemicalsTechnetium Compounds

Study Officials

  • Jean-Francois Rodier, MD

    Centre Paul Strauss

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

October 1, 2002

Study Completion

May 1, 2007

Last Updated

May 15, 2013

Record last verified: 2007-09

Locations

FR(7)