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Recruiting NCT07106112

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided carbon suspension (Black Eye) injection, Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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.

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).

Detailed 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.

Interventions

  • Procedure Ultrasound-guided carbon suspension (Black Eye) injection
    Under ultrasound guidance, 0.5 mL of sterile carbon particle suspension (Black Eye) is injected into the capsule of the metastatic axillary lymph node(s). Technique: Performed using a high-frequency linear ultrasound probe (e.g., 12 MHz) and a 22G needle. Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of neoadjuvant systemic therapy (NST). Rationale: Carbon suspension provides long-term visual localization due to its black staining proper
  • Procedure Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement
    A 4-mm nitinol (nickel-titanium alloy) marker (TWIRL ULTRACOR) is deployed into the metastatic lymph node(s) under ultrasound guidance. Technique: Uses a specialized introducer kit for precise placement. Target: Up to 3 pathologically confirmed metastatic lymph nodes. Timing: Performed before initiation of NST. Rationale: Nitinol markers are radiopaque, MRI-compatible, and resistant to migration. Standard method for tumor localization in breast cancer. Post-Marking Protocol: Identical NST a

Primary outcome measures

  • Intraoperative detection rate of marked lymph nodes (%) [Time frame: Assessed intraoperatively (day of surgery).]
Secondary outcome measures (2)
  • Time from Marking to Surgery (Days) [Time frame: From the date of marking procedure (Day 0) to the date of surgery (up to 12 weeks post-marking)]
  • Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module [EORTC QLQ-BR23] Scores [Time frame: 1. Baseline (pre-marking), 2. Post-neoadjuvant therapy (pre-surgery) 3. 1-month postoperatively.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Russia · 1 center
  • St. Petersburg State University — Saint Petersburg

Identifiers

NCT: NCT07106112 · 05/45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗