Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer

Study Overview
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Brief Summary
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This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages. In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Detailed Description
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5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI). indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time. using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe. ICG can be visualized with a fluorescence imaging system confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy

Official Title
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Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: sentinel lymph node biopsy(SLNB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: breast cancer patients who receive neoadjuvant chemotherapy cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM) ECOG Performance status 0 or 1 consented patients with more than 20 years, less than 70 years Exclusion Criteria: history of breast cancer early stage breast cancer history of excisional or incisional biopsy or axillary dissection inflammatory breast carcinoma cN3 on tumor lymphnode metastasis classification(TNM) history of hormone therapy or targeted therapy stage 4 breast cancer 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: sentinel lymph node biopsy(SLNB)|incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe. double check after removal of the sentinel lymph node sending frozen biopsy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification rate of sentinal lymph node biopsy | It was defined as the ability to identify a sentinel lymph node successfully. | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of sentinel lymph node biopsy | It was defined as the time from the skin incision to complet removal of the first sentinel lymph node. | during operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoadjuvant chemotherapy, Indocyanine green (ICG), Radioisotope (RI), Near infrared fluorescence camera