NCT02168452

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	sentinel lymph node biopsy(SLNB)	* incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe. * double check after removal of the sentinel lymph node * sending frozen biopsy

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-09-01
• Completion: 2015-01-01
• First posted: 2014-06-20
• Last updated: 2016-02-05

Locations

1 site across 1 country: South Korea