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NCT Number: NCT02168452

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sentinel lymph node biopsy(SLNB)

Procedure
  • 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

Primary outcomes

  1. Identification rate of sentinal lymph node biopsy

    Time frame: during operation

    It was defined as the ability to identify a sentinel lymph node successfully.

Secondary outcomes

  1. 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.

Other outcomes

  1. Physical assess

    Time frame: follwing up a week to 3month

    • assess pigmented skin lesion
    • assess for other complication

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jun 20, 2014
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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