Clinical trial · Interventional
Selective Lymph Node Dissection Using Fluorescent Dye in Node-positive Breast Cancer
NCT02781259CI-TRIAL-00023944unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
In this study, navigation of lymphatic passage after sentinel lymph node with indocyanine green was performed during axillary lymph node dissection in breast surgery . By comparing the concordance between the passage of indocyanine green and actual lymph node metastasis, selective lymph node dissection can be developed.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axillary lymph node dissection | Procedure | — | UNRESOLVED |
| Imaging devices | Device | — | UNRESOLVED |
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Selective Lymph Node Dissection
- description
- 10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery. Routine axillary lymph node dissection is performed. Acquired lymph nodes are separated to fluorescent positive lymph nodes and fluorescent negative lymph nodes with imaging devices.
- interventionNames
- Procedure: Axillary lymph node dissection
- Drug: Indocyanine green
- Device: Imaging devices
Primary outcomes (1)
- measure
- Number of metastatic lymph nodes in fluorescent positive lymph nodes and fluorescent negative lymph nodes confirmed by pathologist
- timeFrame
- within 2 weeks (plus or minus 3 days) after surgery
- description
- Concordance analysis is done by comparing lymph node metastasis between fluorescent positive lymph nodes and fluorescent negative lymph nodes.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Operable breast cancer patient * Preoperatively axillary lymph node positive proven patients or sentinel lymph node positive patients whom requires axillary lymph node dissection Exclusion Criteria: * Breast cancer history * Occult breast cancer * Past history of axillary surgery * Iodine hypersensitivity * Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.