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NCT Number: NCT06212440

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

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).

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Key information

Conditions

Sentinel Lymph Node Biopsy Breast Diseases Breast Neoplasm Breast Neoplasms Neoadjuvant Therapy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radioactive Isotope (RI) Mapping

Diagnostic Test

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

Indocyanine Green Fluorescence (ICG-F) Mapping

Diagnostic Test

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

Vital Dye Mapping

Diagnostic Test

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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