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

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ClinicalTrials.gov Identifier: NCT02479997
Recruitment Status : Unknown
Verified February 2016 by Seeyoun Lee, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : June 24, 2015
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Seeyoun Lee, National Cancer Center, Korea

Brief Summary:

This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only.

To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Indocyanine green Drug: Radioisotope Phase 2

Detailed Description:

Using mixture of indocyanine green (ICG) with radioisotope (RI) can guide surgeons to identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast to the axillary lymph node basin.

Last pilot study, sentinel lymph node was successfully identified by using dual method of ICG and RI in 5 patients. In this study, when radiolabeled colloid is used, a gamma probe identifies radioactivity in the lymph nodes in the axilla. If ICG, RI both used, Near infrared fluorescence camera visualized during surgery.

As investigators measure node detection time from axillary approach moment, investigators are going to compare detection rate. (ICG+RI or RI only). And determine the accuracy.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.The protocol required that 130 patients who receive neoadjuvant chemotherapy.

In this study investigators 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.

Sentinel lymph node mapping with both ICG and radiolabeled colloid mapping agents was recommended to maximize the likelihood of SLN identification and to minimize the possibility of missing SLNs, which could result in a false-negative event.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Therapy(Chemotherapy, Hormonal Therapy, Targeted Therapy); Clinical Study for 130 Patients
Study Start Date : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Radioisotope (RI)

Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy.

Interventions - patient assigend RI groups are injected only RI

  • fill the Primay Case Report Form during surgery

    • PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .
Drug: Indocyanine green

ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.

In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.

Other Name: ICG

Drug: Radioisotope
Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.
Other Name: RI

Active Comparator: Indocyanine green (ICG) +RI

Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy.

Interventions - patient assigend RI groups are injected RI +ICG

  • prepare fluorescence camera when the surgery begin
  • surgeon uses the camera to decect fluorescence flow on SLN
  • fill the Primay Case Report Form during surgery

    • PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-
Drug: Indocyanine green

ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.

In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty.

Other Name: ICG

Drug: Radioisotope
Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.
Other Name: RI




Primary Outcome Measures :
  1. Identification rate of sentinel lymphnode biopsy [ Time Frame: Participants will be followed for 2 weeks from operation ]

Secondary Outcome Measures :
  1. Duration of sentinel lymphnode biopsy [ Time Frame: 3months follow up from the day of operation ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • breast cancer patients who receive neoadjuvant therapy (chemotherapy,hormonal therapy, targeted therapy)
  • cN1-cN2 or cN3( but must be complete response status)on tumor lymphnode metastasis classification( TNM) after neoadjuvant therapy.
  • 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)
  • stage 4 breast cancer
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479997


Contacts
Contact: Seeyoun Lee +82-31-920-1736 ext 1736

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

Responsible Party: Seeyoun Lee, Medical Doctor, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT02479997     History of Changes
Other Study ID Numbers: NCC-1410201-2
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016

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

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