The goal of this clinical trial is to exploring the use of Mannitol 20% as a solvent to prepare ICG solution, combining with Voluven, forming a hybrid small-large molecular weight solvent for protecting ICG in monomer form and stimulating lymphatic uptake simultaneously in early breast cancer patients who is indicated to undergo sentinel lymph node biopsy. The main question it aims to answer is: * Will adding Mannitol with Voluven as ICG solvent improve the fluorescence signal of the lymph nodes, comparing with using pure Voluven? * Which proportion of Mannitol-Voluven delivers the best image quality when used as solvent of ICG? Researchers will compare the following arms with different solvent (all arms' final ICG concentration are 0.25mg/mL): * Pure Voluven * Mannitol:Voluven = 1:10 * Mannitol:Voluven = 1:8 * Mannitol:Voluven = 1:6 * Mannitol:Voluven = 1:4 to see if increased Mannitol:Voluven ratio as ICG solvent translates to better fluorescence image quality. Participants will be invited in a group of 3, and be blindly assigned to each concentration group sequentially. Participants will undergo ICG fluorescence guided sentinel lymph node biopsy with the assigned solution formula. The endpoints included number of lymph nodes obtained, fluorescence signal-to-background ratio of the lymph nodes, lymphatic uptake rate, lymphatic drainage speed, detection method, lymph node pathology, and any intra- or post-operative complications.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
30
The procedure includes: (1) preparation of specific formula of ICG:Voluven solution (2) injection of ICG solution at subarelar area or peri-tumoral area (3) observation of fluorescent lymphatic drainage and retrieval of sentinel lymph nodes
Adding Mannitol into Voluven and used as solvent of ICG
National Taiwan University Hospital Hsinchu Branch
Hsinchu County, Taiwan
Number of sentinel lymph nodes
The number of the retrieved sentinel lymph nodes
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Fluorescence signal-to-background ratio of the lymph nodes
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymphatic uptake rate
The time from injection to the development of fluorescent subcutaneous lymphatics
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymphatic drainage speed
The time from the initiation of visible fluorescent subcutaneous lymphatics to that reaches the axilla
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Detection method
The method of the sentinel lymph node being detected. (Could be radioisotope, blye dye, ICG fluorescence, or combination of multiple methods)
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
Lymph node pathology
The positivity of sentinel lymph node metastasis in the pathology report.
Time frame: From the procedure day to the follow-up clinic visit day (average 10 days)
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