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

Primary Purpose

Breast Neoplasms

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Axillary lymph node dissection
Indocyanine green
Imaging devices
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms focused on measuring Sentinel Lymph Node Biopsy, Fluorescence, Breast Neoplasms, Indocyanine Green

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung medical centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selective Lymph Node Dissection

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.

Secondary Outcome Measures

Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes
Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis

Full Information

First Posted
May 8, 2016
Last Updated
September 18, 2016
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02781259
Brief Title
Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Official Title
Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Sentinel Lymph Node Biopsy, Fluorescence, Breast Neoplasms, Indocyanine Green

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selective Lymph Node Dissection
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary lymph node dissection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
Diagnogreen
Intervention Description
10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
Intervention Type
Device
Intervention Name(s)
Imaging devices
Intervention Description
Near-infrared fluorescence is collected by imaging lenses and digital camera.
Primary Outcome Measure Information:
Title
Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
Description
Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.
Time Frame
within 2 weeks (plus or minus 3 days) after surgery
Secondary Outcome Measure Information:
Title
Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes
Description
Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis
Time Frame
within 2 weeks (plus or minus 3 days) after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SeokWon Kim, MD. PhD.
Phone
+82-2-3410-3479
Email
seokwon1.kim@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SeokWon Kim, MD. PhD.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SeokWon Kim, Md. PhD
Phone
+82-2-3410-3479
Email
seokwon1.kim@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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