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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT02168452
• Lead Sponsor: National Cancer Center, Korea

Brief 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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Primary Completion: 2014-09
• Study Completion: 2015-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-04
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5

Inclusion Criteria

• breast cancer patients who receive neoadjuvant chemotherapy
• cN1-cN2 or cT2 on tumor lymphnode metastasis classification(TNM)
• ECOG Performance status 0 or 1
• consented patients with more than 20 years, less than 70 years

Exclusion Criteria

• history of breast cancer
• early stage breast cancer
• history of excisional or incisional biopsy or axillary dissection
• inflammatory breast carcinoma
• cN3 on tumor lymphnode metastasis classification(TNM)
• history of hormone therapy or targeted therapy
• stage 4 breast cancer
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification rate of sentinal lymph node biopsy	during operation	It was defined as the ability to identify a sentinel lymph node successfully.

Secondary Outcome Measures

Name	Time	Method
duration of sentinel lymph node biopsy	during operation	It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of