Application of Surgical Navigation System in Sentinel Lymph Node of Breast Cancer Research

Study Overview
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Brief Summary
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The purpose of this study is to compare the sentinel lymph node (SLN) detection rate of early breast cancer patients between using Indocyanine green (ICG) and Methylene blue with a novel surgical navigation system.

Detailed Description
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Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. However, the existing methods, including methylene blue and nuclides, possess low efficiency and effectiveness in mapping SLNs, and to a certain extent exert side effects during application. Indocyanine green (ICG), as a fluorescent dye, has been proved reliable usage in SLN detection by several other groups. In this paper, the investigators introduce a novel surgical navigation system to detect SLN with ICG. This system contains two charge-coupled devices (CCD) to simultaneously capture real-time color and fluorescent video images through two different bands. During surgery, surgeons only need to follow the fluorescence display. In addition, the system saves data automatically during surgery enabling surgeons to find the registration point easily according to image recognition algorithms. The investigators aim to show that the usage of our surgical navigation system with ICG to detect SLNs in breast cancer patients is technically feasible.

Official Title
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Study of Surgical Navigation System in Detection of Sentinel Lymph Node of Early Breast Cancer Patients

Conditions
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Sentinel Lymph Node, Breast Cancer

Intervention / Treatment
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* Drug: Indocyanine green
* Drug: methylene blue


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: (Before the test, all the subjects required for meeting the entry requirements before they join the group) female patients; The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer; tumor diameter ≤ 3cm; No clinical examination of suspicious axillary lymph node-positive; diagnosed clinical conditions can be directly surgery as I, II breast cancer patients; preoperative clinical or radiologic evidence without distant metastases (M0); signed informed consent. Exclusion criteria: (Before the test, the subjects under any one of items to meet the requirements can not be enrolled) Sentinel lymph node biopsy history had received surgery or axillary area; multi-center breast cancer or multiple lesions; clinical axillary lymph node metastasis have been found; mammary area had received neoadjuvant chemotherapy or radiotherapy; inflammatory breast cancer; pregnancy; no personal freedom and independent civil capacity. Exclusion criteria: (trials, subjects necessary to meet the requirements of any one item, exit the clinical trial research.) severe allergic reaction occurs; persistent allergic reaction; subjects were required to withdraw from a clinical trial; researchers consider it not appropriate to continue to participate in the clinical trial investigator.
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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine green & methylene blue,<br>Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1% Indocyanine green with 1ml of 0.5% | Drug: Indocyanine green<br>* Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%<br>* Other names: ICG;Drug: methylene blue<br>* Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%<br>* Other names: MB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel lymph node detection rate | Participants will be followed for the duration of hospital stay, an expected average of 1 year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-infrared fluorescence, Image guided surgery, Breast cancer;, Sentinel lymph node biopsy, Indocyanine green, Methylene blue