Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
Indocyanine green Advantages: provides visualization of sentinel lymph node without incision
Blue dye Advantages: easy to employ; no toxicity Disadvantages: diffusion; absorption and
disappearance of the marking within minutes
Radioisotope Advantages: can be used for lesions not accessible to Ultrasound; ideal for
selective uptake to sentinel lymph node Disadvantages: not able to use palpation and
visualization, confirms by gamma-probe only
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Time to sentinel lymph node biopsy
From the date of randomization, skin necrosis and dye staining are assessed up to 6 months after the operation (post op 3 mon and 6 mon follow-up).
up to 6 months
Yes
So-Youn Jung
Principal Investigator
National Cancer Center, Korea
Korea: National Cancer Center
NCC-1110212-2
NCT01856452
September 2011
October 2012
Name | Location |
---|