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Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT02781259
Recruitment Status : Unknown
Verified September 2016 by Seok Won Kim, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 24, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Seok Won Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE May 8, 2016
First Posted Date  ICMJE May 24, 2016
Last Update Posted Date September 20, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist [ Time Frame: within 2 weeks (plus or minus 3 days) after surgery ]
Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02781259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes [ Time Frame: within 2 weeks (plus or minus 3 days) after surgery ]
Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Official Title  ICMJE Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Brief Summary In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.
Detailed Description Low dose of indocyanine green emits near-infrared fluorescence, which can penetrate thin tissues like breast or skin. The operator can track the lymphatic pathway without skin incision in real time. By these characteristics, indocyanine green is currently used for sentinel lymph node biopsy in breast cancer surgery. Indocyanine green can also stain lymph nodes beyond the sentinel lymph nodes. This is why we can identify the lymphatic metastasis pathway of breast cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Procedure: Axillary lymph node dissection
    Lymph node dissection is performed in axillary lymph node level I and II. In case of palpable nodes in level II, additional lymph node dissection in level III is done.
  • Drug: Indocyanine green
    10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
    Other Name: Diagnogreen
  • Device: Imaging devices
    Near-infrared fluorescence is collected by imaging lenses and digital camera.
Study Arms  ICMJE Experimental: Selective Lymph Node Dissection
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.
Interventions:
  • Procedure: Axillary lymph node dissection
  • Drug: Indocyanine green
  • Device: Imaging devices
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Operable breast cancer patient
  • Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection

Exclusion Criteria:

  • Breast cancer history
  • Occult breast cancer
  • Past history of axillary surgery
  • Iodine hypersensitivity
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 70 Years   (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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02781259
Other Study ID Numbers  ICMJE 2015-01-046-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seok Won Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: SeokWon Kim, MD. PhD. Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date September 2016

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