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.

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).

Interventions:

Group 1: Ultrasound-guided injection of 0.5 mL carbon suspension (Black Eye). Group 2: Ultrasound-guided placement of a metallic marker (TWIRL ULTRACOR). Follow-up: 6 months post-surgery. Design: Randomized 1:1, non-inferiority trial.

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).