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

National Cancer Center (NCC)

Status: Completed

Conditions: Breast Neoplasm; Neoadjuvant Therapy; Sentinel Lymph Node Biopsy

Treatments: Diagnostic Test: Vital Dye Mapping; Diagnostic Test: Indocyanine Green Fluorescence (ICG-F) Mapping; Diagnostic Test: Radioactive Isotope (RI) Mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT06212440

2010242-2

Details and patient eligibility

About

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).

Full 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).

Enrollment: 348 patients

Sex: Female

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 3 patient groups

RI + ICG-F

Experimental group

Description:

Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.

Treatment:

Diagnostic Test: Radioactive Isotope (RI) Mapping

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

RI + Vital Dye

Experimental group

Description:

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

Treatment:

Diagnostic Test: Radioactive Isotope (RI) Mapping

Diagnostic Test: Vital Dye Mapping

Vital Dye + ICG-F

Experimental group

Description:

Participants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping.

Treatment:

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

Diagnostic Test: Vital Dye Mapping