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NCT Number: NCT07106112

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg State University

Saint Petersburg, Russia

Location status: Recruiting

Location contact

St. Petersburg State University

CONTACT

[email protected]

+7 (812) 363-60-00

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ultrasound-guided carbon suspension (Black Eye) injection

Procedure

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 properties.

Inert and biocompatible, with minimal risk of allergic reactions. Patients proceed to standard NST based on tumor subtype (chemotherapy, targeted therapy, or endocrine therapy).

Post-NST imaging (ultrasound, CT, or PET-CT) to assess treatment response.

Surgical Intervention:

Targeted axillary dissection (TAD) with removal of marked nodes + sentinel lymph node biopsy (SLNB) using fluorescent dye.

Intraoperative frozen section analysis (hematoxylin & eosin staining) of excised nodes.

Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement

Procedure

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 and imaging follow-up as Group 1.

Surgical Intervention:

TAD with marker localization (palpation/imaging-guided excision) + SLNB. Intraoperative frozen section analysis.

Primary outcomes

  1. Intraoperative detection rate of marked lymph nodes (%)

    Time frame: Assessed intraoperatively (day of surgery).

    The proportion of successfully identified and excised marked lymph nodes during surgery, confirmed by visual (carbon suspension) or imaging/metallic detection (metallic marker)

Secondary outcomes

  1. 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)

    Measures the duration (in days) between the lymph node marking procedure (carbon suspension or metallic seed placement) and the subsequent surgical intervention (targeted axillary dissection). This assesses the clinical feasibility and logistical timeline between marking and definitive treatment

  2. 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.

    Patient-reported outcomes assessed using the validated 23-item EORTC QLQ-BR23 questionnaire, which measures:

    Functional scales (Body Image, Sexual Functioning, Sexual Enjoyment, Future Perspective; higher scores = better outcomes), Symptom scales (Systemic Therapy Side Effects, Breast Symptoms, Arm Symptoms, Upset by Hair Loss; higher scores = worse outcomes).

    All items are scored 1-4 (raw scores) and transformed to a 0-100 scale. For functional scales, 100 represents optimal functioning; for symptom scales, 100 represents maximal symptom burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Alina A Olchonova, Physician

CONTACT

[email protected]

+79818197785

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study 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.

Acronym: COMET

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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