A Phase 1/2 interventional study of Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer and Mannitol (20%) in Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by National Taiwan University Hospital. Enrolling by invitation at 1 site in Taiwan. Open to female participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by National Taiwan University Hospital · Phase 1/2, Interventional, and Other
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:
Researchers will compare the following arms with different solvent (all arms' final ICG concentration are 0.25mg/mL):
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
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Exclusion Criteria:
The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution.
Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer
The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer · Drug: Mannitol (20%)
The solution is prepared using Mannitol(20%):Voluven=1:8 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer · Drug: Mannitol (20%)
The solution is prepared using Mannitol(20%):Voluven=1:6 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer · Drug: Mannitol (20%)
The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
Procedure: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer · Drug: Mannitol (20%)
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
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)
Plan to share: Undecided
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National Taiwan University Hospital