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

February 4, 2016 updated by: Seeyoun Lee, National Cancer Center, Korea

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer patients who receive neoadjuvant chemotherapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification rate of sentinal lymph node biopsy
Time Frame: during operation
It was defined as the ability to identify a sentinel lymph node successfully.
during operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of sentinel lymph node biopsy
Time Frame: during operation
It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.
during operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical assess
Time Frame: follwing up a week to 3month
  • assess pigmented skin lesion
  • assess for other complication
follwing up a week to 3month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Seeyoun Lee, National Cancer Center, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 18, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-1410201-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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