A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients

Study Overview
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Brief Summary
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A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.

Detailed Description
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Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.

Official Title
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A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The participants will be assigned to sentinel lymph node biopsies using different concentrations of voluven based indocyanine green. Estimated concentration grouping (ICG mg / Voluven mL): 2.5, 0.5, 0.25, 0.125, 0.0625. Planned recruiting at least 3 participants in each diluted concentration group. The dilution rate will advance if imaging quality is improving compared with the last concentration group. The study will be completed if the best imaging quality injection protocol is found.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Voluven diluted indocyanine green<br>This arm participants uses Voluven diluted ICG for sentinel lymph node mapping. | Procedure: Near infrared fluorescence navigated sentinel lymph node mapping<br>* Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.<br>|
| Active Comparator: Distilled-water diluted indocyanine green<br>This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping. | Procedure: Near infrared fluorescence navigated sentinel lymph node mapping<br>* Patient will undergo sentinel lymph node biopsy with near infrared fluorescence navigation. The dosage of ICG will not exceed 2.5 mg in total, and the volume of the assigned solvent will not exceed 5 mL in total.<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 | 
| Penetration depth | Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast | 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 | 
| Time to total visualization of breast subcutaneous lymphatics | The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics | 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, Sentinel lymph node biopsy, Axillary lymph node dissection