Clinical trial · Interventional
Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
A Randomized Trial Comparing Carbon Suspension (Black Eye) and Metallic Markers (TWIRL ULTRACOR) for Localization of Metastatic Axillary Lymph Nodes Prior to Neoadjuvant Systemic Therapy in Breast Cancer 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 single-center, randomized study aims to compare the intraoperative detection rates of axillary lymph nodes marked with carbon suspension versus metallic markers in breast cancer patients (T1-3N1M0) before neoadjuvant therapy. Primary endpoint: frequency of marked lymph node identification during surgery. Secondary endpoints: time from marking to surgery and quality of life (EORTC QLQ-BR23).
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 |
|---|---|---|---|
| Ultrasound-guided carbon suspension (Black Eye) injection | Procedure | — | UNRESOLVED |
| Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carbon Suspension (Black Eye) Marking
- interventionNames
- Procedure: Ultrasound-guided carbon suspension (Black Eye) injection
- type
- ACTIVE_COMPARATOR
- label
- Metallic Marker (TWIRL ULTRACOR) Placement
- interventionNames
- Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement
Primary outcomes (1)
- measure
- Intraoperative detection rate of marked lymph nodes (%)
- timeFrame
- Assessed intraoperatively (day of surgery).
- description
- The proportion of successfully identified and excised marked lymph nodes during surgery, confirmed by visual (carbon suspension) or imaging/metallic detection (metallic marker)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥18 years. * Morphologically confirmed breast cancer (T1-3N1M0). * ECOG 0-1. * Indication for neoadjuvant therapy. * Signed informed consent. Exclusion Criteria: * No lymph node regression post-neoadjuvant therapy (persistent N1). * Distant metastasis progression. * Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).
References
Publications (0)
Data not yet available