NCT06768268View on ClinicalTrials.gov

A Dose-Image Optimization Trial Evaluating Mannitol and Voluven as Adjuncts for Indocyanine Green

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Interventions
PROCEDURE

Voluven-assisted Indocyanine green fluorescence guided sentinel lymph node biopsy for breast cancer

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

DRUG

Mannitol (20%)

Adding Mannitol into Voluven and used as solvent of ICG

Trial Locations (1)

302

National Taiwan University Hospital Hsinchu Branch, Hsinchu County

All Listed Sponsors
collaborator

National Yang Ming Chiao Tung University

OTHER

collaborator

National Taiwan University Hospital Hsin-Chu Branch

OTHER

lead

National Taiwan University Hospital

OTHER