Clinical trial · Interventional
Comparison Study of Sentinel Lymph Node Biopsy by Multimodal Method in Breast Cancer
Phase II Study of Comparison of Sentinel Lymph Node Biopsy Guided by The Multimodal Method of Indocyanine Green Fluorescence, Radioisotope and Blue Dye Versus the Radioisotope in Breast Cancer
- 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)
Sentinel lymph node biopsy (SLNB) has become a mainstay surgery method in breast cancer. It provides the surgeon the evidence of axillary lymph node metastasis, which determines the extent of surgery. Because effective SLNB can decrease the extent of axillary lymph node dissection, it is increasingly important. In general, radioactive colloid has been used for SLNB. In order to pursue more precise SLNB, the investigators developed a multimodal method enabling visual guidance with the mixture of indocyanine green, blue dye and radioisotope. In this study, our hypotheses are as following: 1. Multimodal method enables to increase identification rate of SLNB 2. blue dye and indocyanine green provide the surgeon visual guidance to ensure better outcome 3. Multimodal method alleviates the shortcomings of indocyanine green and blue dye as an identification strategy
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radioisotope | Device | — | UNRESOLVED |
| the mixture including indocyanine green | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- radioisotope
- description
- sentinel lymph node operation using radioisotope in the breast cancer patients
- interventionNames
- Device: radioisotope
- type
- EXPERIMENTAL
- label
- the mixture including indocyanine green
- description
- sentinel lymph node operation using the mixture of indocyanine green, blue dye and radioisotope in the breast cancer patients
- interventionNames
- Device: the mixture including indocyanine green
Primary outcomes (1)
- measure
- Time to sentinel lymph node biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * clinically lymph node negative breast cancer patients * consented patients with more than 20 years Exclusion Criteria: * history of breast cancer * locally advanced breast cancer and metastatic breast cancer * proven axillary lymph node metastasis * history of axillary excisional or incisional biopsy, or dissection * history of neoadjuvant chemotherapy * pregnancy * non-consented patients * younger than 20 years old
References
Publications (0)
Data not yet available