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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Axillary lymph node dissection
* Drug: Indocyanine green
* Device: Imaging devices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Selective Lymph Node Dissection<br>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<br>* 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.<br>Drug: Indocyanine green<br>* 10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery<br>* Other names: Diagnogreen;Device: Imaging devices<br>* Near-infrared fluorescence is collected by imaging lenses and digital camera.<br>|

What is the study measuring?
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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 | 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 | Risk factor analysis of fluorescent negative lymph node with positive lymph node metastasis | within 2 weeks (plus or minus 3 days) after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Biopsy, Fluorescence, Breast Neoplasms, Indocyanine Green