Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer

Breast Cancer Clinical Trial

Official title: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study

Status Completed

Clinical Trial Summary

This study aimed to evaluate the feasibility of dual sentinel node staining method using mixture of indocyanine green(ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.

Over the past few years, several studies have found using methylene blue, isosulfan blue, indocyanine green or radioisotope alone by detection method had several disadvantages.

In this study we expects using mixture of indocyanine green (ICG) with radioisotope (RI) has potential to improve sentinel lymph node (SLN) mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Clinical Trial Description

• 5 patients who receive neoadjuvant chemotherapy with cN1-cN2 or cT2 on TNM staging

• sentinel lymph node biopsy(SLNB) by sentinel lymph node staining method using mixture of indocyanine green (ICG) with radioisotope (RI).

• indocyanine green (ICG) penetrates human tissue to depths of several millimeters to 2cm, and the fluorescence can be detected percutaneously in real time.

• using RI only has several disadvantages such as invisibility,interference. RI only detect sound or confirm numerical value through gamma probe.

• ICG can be visualized with a fluorescence imaging system

• confirm Identification rate of sentinal lymph node biopsy, and duration of sentinel lymph node biopsy ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02168452
• Study type: Observational [Patient Registry]
• Source: National Cancer Center, Korea
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Completion date: January 2015