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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
24
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.
National Taiwan University Hospital Hsin-Chu Branch Biomedical Park Hospital
Zhubei, HsinChu County, Taiwan
RECRUITINGSignal-to-background ratio (SBR)
Evaluates the SBR of the near-infrared fluorescence between the retrieved sentinel lymph nodes and the background.
Time frame: through study completion, an average of 1 year
Penetration depth
Evaluates the depth of the deepest visualized subcutaneous lymphatics in the breast
Time frame: through study completion, an average of 1 year
Sentinel lymph nodes pathology
The positivity and number of retrieved sentinel lymph nodes at definitive pathology report.
Time frame: 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
Time frame: through study completion, an average of 1 year
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