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

NARecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 15, 2025

Primary Completion Date

May 15, 2026

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
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 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."

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

Trial Locations (1)

Unknown

RECRUITING

St. Petersburg State University, Saint Petersburg

All Listed Sponsors
lead

Saint Petersburg State University, Russia

OTHER