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Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

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ClinicalTrials.gov Identifier: NCT00314405
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : August 8, 2008
Sponsor:
Information provided by:
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE April 11, 2006
First Posted Date  ICMJE April 13, 2006
Last Update Posted Date August 8, 2008
Study Start Date  ICMJE April 2006
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
Determination of an optimized protocol for SLN identification, with a double method using isotope and methylene blue dye injection.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00314405 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2006)
  • Comparison of the results of SLN serial sectioning, with H&E and IHC staining
  • Economical evaluation of SLN procedure.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2006)
  • Comparison of the results of SLN serial sectioning, with he and ihc staining
  • Economical evaluation of SLN procedure.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infiltrative Breast Cancer
Intervention  ICMJE
  • Drug: Methylene blue (1%)
  • Drug: Rhenium sulfure
  • Procedure: Surgical procedure
  • Procedure: Anatomo-pathologic procedure
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 11, 2006)
100
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00314405
Other Study ID Numbers  ICMJE 3157
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jean-Pierre Bellocq, MD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date February 2008

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