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

National Taiwan University Hospital Hsin-Chu Branch

Status and phase: Unknown; Phase 1

Conditions: Sentinel Lymph Node; Breast Cancer

Treatments: Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT05365204

111-009-F

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Voluven diluted indocyanine green

Experimental group

Description:

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

Treatment:

Procedure: Near infrared fluorescence navigated sentinel lymph node mapping

Distilled-water diluted indocyanine green

Active Comparator group

Description:

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

Treatment:

Procedure: Near infrared fluorescence navigated sentinel lymph node mapping