NCT02781259

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
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
DEVICE	Imaging devices	Near-infrared fluorescence is collected by imaging lenses and digital camera.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-02-01
• Completion: 2017-04-01
• First posted: 2016-05-24
• Last updated: 2016-09-20

Locations

1 site across 1 country: South Korea