Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer

Breast Neoplasms Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope.

In this study, our hypotheses are as following:

1. Multimodal method enables to increase identification rate of SLNB

2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome

3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy

Clinical Trial Description

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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT01856452
• Study type: Interventional
• Source: National Cancer Center, Korea
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Completion date: October 2012