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

September 18, 2016 updated by: Seok Won Kim, Samsung Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 2 weeks (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 2 weeks (plus or minus 3 days) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 24, 2016

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 18, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-01-046-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe