Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy

March 10, 2025 updated by: Seeyoun Lee, National Cancer Center, Korea

Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Chemotherapy : Expanded Access Clinical Study in 3 Arms

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After NAC, the sentinel lymph node (SLN) identification rate is lower, and it has a higher false-negative rate than that in early-stage breast cancer. As appropriate SLN surgery directly affects the treatment and prognosis of patients undergoing NAC, evaluation to identify SLN using various methods is necessary.

This clinical trial aimed to confirm the effectiveness of sentinel lymph node surgery by determining the lymph node identification rate using multimodal sentinel lymph node marker methods in patients with advanced breast cancer undergoing neoadjuvant chemotherapy (NAC).

Study Type

Interventional

Enrollment (Actual)

348

Phase

  • Not Applicable

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
      • Goyang, Gyeonggi, Korea, Republic of, 82
        • National Cancer Center
    • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • The patient with locally advanced breast cancer who achieved neoadjuvant chemotherapy
  • Confirmed operability with imaging study after neoadjuvant chemotherapy
  • Age over 20 years old
  • ECOG Performance status : 0-2
  • The patient with written informed consent form

Exclusion Criteria:

  • The patient with previous ipsilateral breast cancer history
  • The patinet with previous ipsilateral axillary surgical procedure (e.g. excisional or incisional biopsy, axillary dissection)
  • The patient without neoadjuvant chemotherapy
  • Inoperable imaging study after neoadjuvant chemotherapy
  • Inflammatory breast cancer
  • Pregnant patient

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RI + ICG-F
Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.
Diagnostic test: Radioactive Isotope (RI) Mapping
Administered via peritumoral or subareolar injection for sentinel lymph node detection.
Diagnostic test: Indocyanine Green Fluorescence (ICG-F) Mapping
Administered via peritumoral or subareolar injection, detected using near-infrared fluorescence imaging.
Experimental: RI + Vital Dye
Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping.
Diagnostic test: Radioactive Isotope (RI) Mapping
Administered via peritumoral or subareolar injection for sentinel lymph node detection.
Diagnostic test: Vital Dye Mapping
Administered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways.
Experimental: Vital Dye + ICG-F
Participants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.
Diagnostic test: Indocyanine Green Fluorescence (ICG-F) Mapping
Administered via peritumoral or subareolar injection, detected using near-infrared fluorescence imaging.
Diagnostic test: Vital Dye Mapping
Administered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification rate of sentinel lymph node
Time Frame: during operation
Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.
during operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of operation time for sentinel lymph node biopsy
Time Frame: during operation
collection of data for operation time between skin incision and detection of sentinel lymph node, following direct comparison between each arms
during operation

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, Doctor, 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 (Actual)

May 4, 2021

Primary Completion (Actual)

August 14, 2024

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010242-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

The data was generated on June 30, 2026, and can be provided for three years thereafter.

IPD Sharing Access Criteria

a publication of a paper about this study

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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