NCT02479997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

February 22, 2023

Status Verified

February 1, 2023

Enrollment Period

2.9 years

First QC Date

May 8, 2015

Last Update Submit

February 21, 2023

Conditions

Breast Cancer

Keywords

Neoadjuvant chemotherapyIndocyanine green (ICG)Radioisotope (RI)Near infrared fluorescence camera

Outcome Measures

Primary Outcomes (1)

  • Identification rate of sentinel lymphnode biopsy

    Participants will be followed for 2 weeks from operation

Secondary Outcomes (1)

  • Duration of sentinel lymphnode biopsy

    3months follow up from the day of operation

Study Arms (2)

Radioisotope (RI)

ACTIVE COMPARATOR

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 greenDrug: Radioisotope

Indocyanine green (ICG) +RI

ACTIVE COMPARATOR

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 greenDrug: Radioisotope

Interventions

Indocyanine greenDRUG

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.

Also known as: ICG
Indocyanine green (ICG) +RIRadioisotope (RI)
RadioisotopeDRUG

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.

Also known as: RI
Indocyanine green (ICG) +RIRadioisotope (RI)

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

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

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine GreenRadioisotopes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIsotopesInorganic Chemicals

Study Officials

  • Seeyoun Lee

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 8, 2015

First Posted

June 24, 2015

Study Start

March 31, 2015

Primary Completion

March 8, 2018

Study Completion

March 27, 2018

Last Updated

February 22, 2023

Record last verified: 2023-02

Locations

KR(1)