Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

Study Overview
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Brief Summary
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Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope. In this study, our hypotheses are as following: Multimodal method enables to increase identification rate of SLNB blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Detailed Description
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Indocyanine green Advantages: provides visualization of sentinel lymph node without incision Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and disappearance of the marking within minutes Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for selective uptake to sentinel lymph node Disadvantages: not able to use palpation and visualization, confirms by gamma-probe only

Official Title
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Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Device: the mixture including indocyanine green
* Device: radioisotope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically lymph node negative breast cancer patients consented patients with more than 20 years Exclusion Criteria: history of breast cancer locally advanced breast cancer and metastatic breast cancer proven axillary lymph node metastasis history of axillary excisional or incisional biopsy, or dissection history of neoadjuvant chemotherapy pregnancy non-consented patients younger than 20 years old

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radioisotope<br>sentinel lymph node operation using radioisotope in the breast cancer patients | Device: radioisotope<br>* Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation<br>|
| Experimental: the mixture including indocyanine green<br>sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients | Device: the mixture including indocyanine green<br>* Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sentinel lymph node biopsy | From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up). | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification rate of sentinel lymph node biopsy | The number of participants with sentinel lymph node detection is assessed up to 13 months. | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel lymph node, multimodal, breast cancer