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Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy

RecruitingNAAges 18 Years - anyFemaleSaint Petersburg State University, Russia
NCT07106112 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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).
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What it tests

  • Ultrasound-guided carbon suspension (Black Eye) injection
  • Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement
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Where

1 site
St. Petersburg State University
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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