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

Last updated: August 2, 2025
Sponsor: Saint Petersburg State University, Russia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Ultrasound-guided carbon suspension (Black Eye) injection

Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement

Clinical Study ID

NCT07106112
05/45
  • Ages > 18
  • Female

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women ≥18 years.

  • Morphologically confirmed breast cancer (T1-3N1M0).

  • ECOG 0-1.

  • Indication for neoadjuvant therapy.

  • Signed informed consent.

Exclusion

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).

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Ultrasound-guided carbon suspension (Black Eye) injection
Phase:
Study Start date:
May 15, 2025
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • St. Petersburg State University

    Saint Petersburg,
    Russian Federation

    Active - Recruiting

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