RecruitingNot ApplicableNCT07106112

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

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.

Sponsor

Saint Petersburg State University, Russia

Enrollment

110 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria3

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

Interventions

PROCEDUREUltrasound-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 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.

PROCEDUREUltrasound-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 and imaging follow-up as Group 1. Surgical Intervention: TAD with marker localization (palpation/imaging-guided excision) + SLNB. Intraoperative frozen section analysis.