Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Study completion date: Apr 2008v8
  2. Publications: details revised at 1 of 1 entryv7
  3. Study Status, Sponsor/Collaborators, Referencesv6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Recruiting to Completed
    • Primary completion date: Apr 2007
    • Site details revised
    v4
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  1. Study title revisedv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study completion date: Apr 2008 to not stated
    • Secondary endpoints revised (2)
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00314405
Lead Sponsor University Hospital, Strasbourg, France
Conditions
(from sponsor)		 Infiltrative Breast Cancer
Related terms Breast Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov