Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT06768268
Brief 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.
Study:
NCT06768268
Study Brief:
Protocol Section:
NCT06768268