Clinical trial · Interventional
Breast Lymph Node Mapping
Axillary Reverse Mapping in Breast Cancer
NCT01038908CI-TRIAL-00009473unknownPhase 2ClinicalTrials.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)
The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isosulfan Blue (Patent Blue Dye V) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.
- interventionNames
- Other: Isosulfan Blue (Patent Blue Dye V)
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Each patient will receive an injection of technetium-99m sulfur colloid directed subareolar or around the tumor. The material will be prepared as per manufacturer's specifications. The dose will be 20mBq given the same day of 80mBq given the day before. The Nuclear Medicine Department at St Paul's Hospital will perform the injection as per normal sentinel lymph node mapping protocol.
- interventionNames
- Other: Isosulfan Blue (Patent Blue Dye V)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. 19-100 years old 2. Not pregnant or breastfeeding 3. Breast cancer requiring LN evaluation for the breast 4. Willing participation following an informed consent process Exclusion Criteria: 1. Patient \< 19 y/o or \> 100 y/o 2. Pregnant or breastfeeding 3. Allergy to blue dye 4. Locally advanced axillary disease 5. History of receiving neoadjuvant chemotherapy treatment 6. Prior axillary surgery or radiation therapy
References
Publications (0)
Data not yet available
No reference posted for this study.