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

NCT02781259 | Unknown Phase 4

• 1 other identifier: 2015-01-046-007
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Sentinel Lymph Node Biopsy; Fluorescence; Breast Neoplasms; Indocyanine Green

Outcome Measures

Primary Outcomes (1)

• 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.

  within 2 weeks (plus or minus 3 days) after surgery

Secondary Outcomes (1)

• Clinicopathological factors associated with lymph node metastasis in fluorescent negative lymph nodes

  within 2 weeks (plus or minus 3 days) after surgery

Study Arms (1)

Selective Lymph Node Dissection

EXPERIMENTAL

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; Drug: Indocyanine green; Device: Imaging devices

Interventions

Axillary lymph node dissection PROCEDURE

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.

Selective Lymph Node Dissection

Indocyanine green DRUG

10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery

Also known as: Diagnogreen

Selective Lymph Node Dissection

Imaging devices DEVICE

Near-infrared fluorescence is collected by imaging lenses and digital camera.

Selective Lymph Node Dissection

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Breast cancer history
• Occult breast cancer
• Past history of axillary surgery
• Iodine hypersensitivity
• Pregnancy

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• SeokWon Kim, MD. PhD.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SeokWon Kim, MD. PhD.

CONTACT

+82-2-3410-3479; seokwon1.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: May 24, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)