Overview
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).
Description
- 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.
Eligibility
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).