Trials / Completed
CompletedNCT06212440
Clinical Application of Multi-modal Sentinel Lymph Node Staining Method in Breast Cancer Patients After Neoadjuvant Chemotherapy
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 348 (actual)
- Sponsor
- National Cancer Center, Korea · Other Government
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Accepted
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).
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DIAGNOSTIC_TEST | Vital Dye Mapping | Administered via peritumoral or subareolar injection for intraoperative visualization of lymphatic drainage pathways. |
Timeline
- Start date
- 2021-05-04
- Primary completion
- 2024-08-14
- Completion
- 2024-10-02
- First posted
- 2024-01-18
- Last updated
- 2025-03-13
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06212440. Inclusion in this directory is not an endorsement.