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

Sponsor
Samsung Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02781259
Collaborator
(none)
150
Enrollment
1
Location
1
Arm
11
Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
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 1, 2016
Anticipated Primary Completion Date :
Feb 1, 2017
Anticipated Study Completion Date :
Apr 1, 2017

Arms and Interventions

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 Names:
  • Diagnogreen

    • Device: Imaging devices
    Near-infrared fluorescence is collected by imaging lenses and digital camera.

    Outcome Measures

    Primary Outcome Measures

    1. Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist [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 [within 2 weeks (plus or minus 3 days) after surgery]

      Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung medical center Seoul Korea, Republic of 06351

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: SeokWon Kim, MD. PhD., Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seok Won Kim, Associate professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT02781259
    Other Study ID Numbers:
    • 2015-01-046-007
    First Posted:
    May 24, 2016
    Last Update Posted:
    Sep 20, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Seok Won Kim, Associate professor, Samsung Medical Center
    Sentinel Lymph Node Biopsy
    Fluorescence
    Breast Neoplasms
    Indocyanine Green
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Sep 20, 2016