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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Breast Neoplasms

Treatments: Procedure: Axillary lymph node dissection; Drug: Indocyanine green; Device: Imaging devices

Study type: Interventional

Funder types: Other

Identifiers

NCT02781259

2015-01-046-007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Selective Lymph Node Dissection

Experimental group

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.

Treatment:

Device: Imaging devices

Procedure: Axillary lymph node dissection

Drug: Indocyanine green