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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

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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Procedure: Axillary lymph node dissection Drug: Indocyanine green Device: Imaging devices Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Study Start Date : May 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781259


Contacts
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Contact: SeokWon Kim, MD. PhD. +82-2-3410-3479 seokwon1.kim@samsung.com

Locations
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Korea, Republic of
Samsung medical center Recruiting
Seoul, Korea, Republic of, 06351
Contact: SeokWon Kim, Md. PhD    +82-2-3410-3479    seokwon1.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: SeokWon Kim, MD. PhD. Samsung Medical Center

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Responsible Party: Seok Won Kim, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02781259     History of Changes
Other Study ID Numbers: 2015-01-046-007
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Seok Won Kim, Samsung Medical Center:
Sentinel Lymph Node Biopsy
Fluorescence
Breast Neoplasms
Indocyanine Green

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases