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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RI + ICG-F | Experimental | Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping. |
|
| RI + Vital Dye | Experimental | Participants undergo sentinel lymph node biopsy using Radioactive Isotope (RI) and Vital Dye for lymphatic mapping. |
|
| Vital Dye + ICG-F | Experimental | Participants undergo sentinel lymph node biopsy using Vital Dye and Indocyanine Green Fluorescence (ICG-F) for lymphatic mapping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radioactive Isotope (RI) Mapping | Diagnostic Test | Administered via peritumoral or subareolar injection for sentinel lymph node detection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of operation time for sentinel lymph node biopsy | collection of data for operation time between skin incision and detection of sentinel lymph node, following direct comparison between each arms | during operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seeyoun Lee, Doctor | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea | ||
| National cancer center |
all IPD that underlie results in a publication
The data was generated on June 30, 2026, and can be provided for three years thereafter.
a publication of a paper about this study
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open-label, prospective, single-institution, 3-arms expended randomized study
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| 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. |
|
| Goyang-si |
| Gyeonggi-do |
| 82 |
| South Korea |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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