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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Seeyoun Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT02168452
First received: June 18, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: sentinel lymph node biopsy(SLNB)

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy; Observational Pilot Study

Resource links provided by NLM:


Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • Identification rate of sentinal lymph node biopsy [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    It was defined as the ability to identify a sentinel lymph node successfully.


Secondary Outcome Measures:
  • duration of sentinel lymph node biopsy [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    It was defined as the time from the skin incision to complet removal of the first sentinel lymph node.


Other Outcome Measures:
  • Physical assess [ Time Frame: follwing up a week to 3month ] [ Designated as safety issue: Yes ]
    • assess pigmented skin lesion
    • assess for other complication


Estimated Enrollment: 5
Study Start Date: June 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer patients who receive neoadjuvant chemotherapy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02168452

Contacts
Contact: Seeyoun Lee +82-31-920-1736 ext 1736 seeyoun@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Seeyoun Lee    +82-31-920-1736 ext 1736    seeyoun@ncc.re.kr   
Contact: Minjung Park    +82-31-920-0848 ext 0848    73625@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Seeyoun Lee National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Seeyoun Lee, Medical Doctor, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02168452     History of Changes
Other Study ID Numbers: NCC-1410201-1
Study First Received: June 18, 2014
Last Updated: June 18, 2014
Health Authority: Korea: National Cancer Center

Keywords provided by National Cancer Center, Korea:
Neoadjuvant chemotherapy
Indocyanine green (ICG)
Radioisotope (RI)
Near infrared fluorescence camera

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014