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

NCT06212440 | Completed DMC

• 1 other identifier: 2010242-2
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Sentinel Lymph Node Biopsy; Neoadjuvant Therapy; Breast Neoplasm

Keywords

breast cancer; sentinel node biopsy; neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Identification rate of sentinel lymph node

  Collection of data for detection rate of sentinel lymph node for each group following direct comparison between each arms.

  during operation

Secondary Outcomes (1)

• Comparison of operation time for sentinel lymph node biopsy

  during operation

Study Arms (3)

RI + ICG-F

EXPERIMENTAL

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; Diagnostic Test: Indocyanine Green Fluorescence (ICG-F) Mapping

RI + Vital Dye

EXPERIMENTAL

Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping.

Diagnostic Test: Radioactive Isotope (RI) Mapping; Diagnostic Test: Vital Dye Mapping

Vital Dye + ICG-F

EXPERIMENTAL

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; Diagnostic Test: Vital Dye Mapping

Interventions

Radioactive Isotope (RI) Mapping DIAGNOSTIC_TEST

Administered via peritumoral or subareolar injection for sentinel lymph node detection.

RI + ICG-F; RI + Vital Dye

Indocyanine Green Fluorescence (ICG-F) Mapping DIAGNOSTIC_TEST

Administered via peritumoral or subareolar injection, detected using near-infrared fluorescence imaging.

RI + ICG-F; Vital Dye + ICG-F

Vital Dye Mapping DIAGNOSTIC_TEST

Administered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways.

RI + Vital Dye; Vital Dye + ICG-F

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (2)

National Cancer Center

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

Location

National cancer center

Goyang-si, Gyeonggi-do, 82, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Seeyoun Lee, Doctor

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, M.D., head of center for breast cancer

Model Details: open-label, prospective, single-institution, 3-arms expended randomized study

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: January 18, 2024
• Study Start: May 4, 2021
• Primary Completion: August 14, 2024
• Study Completion: October 2, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data was generated on June 30, 2026, and can be provided for three years thereafter.
• Access Criteria: a publication of a paper about this study

Locations

KR (2)