A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients

Study Overview
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Brief Summary
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This study aims for evaluating near infrared zone II imaging in sentinel lymph node mapping in breast cancer patients.

Detailed Description
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Multi-wavelength fluorescence has been surveyed in various fields of surgery. However, it was still under investigation, and has not been matured for clinical use. This study will evaluate near infrared zone II spectrums for breast cancer patient undergoing sentinel lymph node mapping with near-infrared fluorescence navigation.

Official Title
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Development and Utilization of Indocyanine Green Fluorescence Near Infrared Zone II Lymphography in Breast Cancer Patients

Conditions
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Breast Cancer, Sentinel Lymph Node

Intervention / Treatment
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* Procedure: Near infrared fluorescence navigated sentinel lymph node mapping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer, adults Exclusion Criteria: Patient aged < 20 years old Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer) Patient who is allergic to primary tracers (including Tc99m and blue dye) Patient who is allergic to indocyanine green

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

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: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multispectral near infrared imaging<br>The participants will be assigned to one single arm that accepted both near infrared zone I and near infrared zone II imaging during the near infrared fluorescence navigated sentinel lymph node biopsy procedure. Imaging quality will be compared between different spectrums. | Procedure: Near infrared fluorescence navigated sentinel lymph node mapping<br>* Participants undergo sentinel lymph node biopsy for breast cancer, and use blue dye/Tc99m radioisotope as primary tracer. Indocyanine green near infrared fluorescence as secondary tracer for mapping.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Signal-to-background ratio (SBR) | Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sentinel lymph nodes pathology | The positivity and number of retrieved sentinel lymph nodes at definitive pathology report. | through study completion, an average of 1 year | 
| Penetration depth | Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indocyanine green, Image-guided surgery, Multispectral fluorescence imaging