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

NCT07106112 | Recruiting

• 1 other identifier: 05/45
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer

Keywords

Carbon suspension; Axillary lymph node marking; Neoadjuvant therapy; Targeted axillary dissection; Metallic marker

Outcome Measures

Primary Outcomes (1)

• Intraoperative detection rate of marked lymph nodes (%)

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

  Assessed intraoperatively (day of surgery).

Secondary Outcomes (2)

• Time from Marking to Surgery (Days)

  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

  1. Baseline (pre-marking), 2. Post-neoadjuvant therapy (pre-surgery) 3. 1-month postoperatively.

Study Arms (2)

Carbon Suspension (Black Eye) Marking

EXPERIMENTAL

Procedure: Ultrasound-guided carbon suspension (Black Eye) injection

Metallic Marker (TWIRL ULTRACOR) Placement

ACTIVE COMPARATOR

Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement

Interventions

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.

Carbon Suspension (Black Eye) Marking

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.

Metallic Marker (TWIRL ULTRACOR) Placement

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥18 years.
• Morphologically confirmed breast cancer (T1-3N1M0).
• ECOG 0-1.
• Indication for neoadjuvant therapy.
• Signed informed consent.

You may not qualify if:

• No lymph node regression post-neoadjuvant therapy (persistent N1).
• Distant metastasis progression.
• Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

St. Petersburg State University

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections; Drug Implants

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Alina A Olchonova, Physician

  Saint Petersburg State University, Russia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alina A Olchonova, Physician

CONTACT

+79818197785; dr.lazakovich@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 6, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

RU (1)