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

NCT ID: NCT02168452

Last Updated: 2016-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Seeyoun Lee

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seeyoun Lee

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCC-1410201-1

Identifier Type: -

Identifier Source: org_study_id