Neoplasms

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Breast Neoplasms

Breast Diseases

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This arm participants uses Voluven diluted ICG for sentinel lymph node mapping.

This arm participants uses Distilled-water diluted ICG for sentinel lymph node mapping.

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.

Near infrared fluorescence navigated sentinel lymph node mapping

Yung-Chun Hsieh, MD

Yang-Hsiang Chan, PhD

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.

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.

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.

The participant will know how many concentration ladders we have, but will not know the exact concentration used on him.

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

Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.

Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast

The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.

The time from injection of indocyanine green to total visualization of breast subcutaneous lymphatics

National Yang Ming Chiao Tung University

National Taiwan University Hospital Hsin-Chu Branch

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.

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.

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

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.

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.

The patient will know they are going to accept near infrared zone II imaging during the sentinel lymph node biopsy procedure. They will not see the images and will not know the quality results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients	NCT05365204	Breast Cancer Sentinel Lymph ...	Near infrared f...	20 Years -	National Taiwan University Hospital Hsin-Chu Branch
A Study Evaluating Near-infrared Zone II Imaging in Sentinel Lymph Node Mapping in Breast Cancer Patients	NCT05365191	Breast Cancer Sentinel Lymph ...	Near infrared f...	20 Years -	National Taiwan University Hospital Hsin-Chu Branch
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients	NCT05365204	Breast Cancer Sentinel Lymph ...	Near infrared f...	20 Years -	National Taiwan University Hospital Hsin-Chu Branch

Spots Global Cancer Trial Database for near infrared fluorescence navigated sentinel lymph node mapping