Clinical trial · Interventional
Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients
Clinical Application of Dual Sentinel Lymph Node Staining Method in Breast Cancer Patients Who Receive Neoadjuvant Therapy(Chemotherapy, Hormonal Therapy, Targeted Therapy); Clinical Study for 130 Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to compare detection rate between dual sentinel node staining method using mixture of indocyanine green (ICG) with radioisotope(RI), and RI only. To identify the first lymph node(s) along the lymphatic drainage pathway from the primary tumor in the breast cancer using RI only has several disadvantages such as invisibility, interference. As ICG can be visualized with a fluorescence imaging system, we expects dual sentinel lymph node staining method had better outcomes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
| Radioisotope | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radioisotope (RI)
- description
- Using RI only as SLNB mapping in breast cancer patients who receive neoadjuvant chemotherapy. Interventions - patient assigend RI groups are injected only RI * fill the Primay Case Report Form during surgery * PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- .
- interventionNames
- Drug: Indocyanine green
- Drug: Radioisotope
- type
- ACTIVE_COMPARATOR
- label
- Indocyanine green (ICG) +RI
- description
- Dual sentinel node staining method using mixture of indocyanine green (ICG) and radioisotope (RI) in breast cancer patients who receive neoadjuvant chemotherapy. Interventions - patient assigend RI groups are injected RI +ICG * prepare fluorescence camera when the surgery begin * surgeon uses the camera to decect fluorescence flow on SLN * fill the Primay Case Report Form during surgery * PCRF including SLN detection time, duration of SLN approch time to 1st sentinel node dection time, incision length , depth, RI +/- , ICG+/-
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * breast cancer patients who receive neoadjuvant therapy (chemotherapy,hormonal therapy, targeted therapy) * cN1-cN2 or cN3( but must be complete response status)on tumor lymphnode metastasis classification( TNM) after neoadjuvant therapy. * ECOG Performance status 0 or 1 * consented patients with more than 20 years, less than 70 years Exclusion Criteria: * history of breast cancer * early stage breast cancer * history of excisional or incisional biopsy or axillary dissection * inflammatory breast carcinoma * cN3 on tumor lymphnode metastasis classification(TNM) * stage 4 breast cancer * pregnancy
References
Publications (0)
Data not yet available