Clinical trial NCT06768268: A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green
Official title: Advanced Research on ICG Fluorescence Imaging-Guided Surgery Technique Using Mannitol and Voluven as Adjuncts
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Summary: 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.
Interventions:
description: 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
name: Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer
type: Procedure
description: Adding Mannitol into Voluven and used as solvent of ICG
name: Mannitol (20%)
type: Drug
Study arms:
design_group_description: The solution is prepared using Voluven as solvent, forming a 0.25 mg/mL ICG:Voluven solution.
design_group_title: Pure Voluven
design_group_type: Active Comparator
design_group_description: The solution is prepared using Mannitol(20%):Voluven=1:10 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
design_group_title: 1:10
design_group_type: Active Comparator
design_group_description: The solution is prepared using Mannitol(20%):Voluven=1:8 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
design_group_title: 1:8
design_group_type: Active Comparator
design_group_description: The solution is prepared using Mannitol(20%):Voluven=1:6 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
design_group_title: 1:6
design_group_type: Active Comparator
design_group_description: The solution is prepared using Mannitol(20%):Voluven=1:4 as solvent, forming a 0.25 mg/mL ICG:Solvent solution.
design_group_title: 1:4
design_group_type: Active Comparator
Sponsor: National Taiwan University Hospital
Collaborators: National Taiwan University Hospital
Drug name mappings:
name: 甘露醇
lang: CN
name: Mannitol
lang: EN
name: D-マンニトール
lang: JP