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

Phase 4

• Conditions: Breast Neoplasms
• Interventions: Procedure: Axillary lymph node dissection; Drug: Indocyanine green; Device: Imaging devices

• Registration Number: NCT02781259
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-24
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-18
• Last Update Posted: 2016-09-20
• Primary Completion: 2017-02
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Selective Lymph Node Dissection	Indocyanine green	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.
Selective Lymph Node Dissection	Imaging devices	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.
Selective Lymph Node Dissection	Axillary 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of