110
Participants
Start Date
May 15, 2025
Primary Completion Date
May 15, 2026
Study Completion Date
December 31, 2026
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."
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."
RECRUITING
St. Petersburg State University, Saint Petersburg
Saint Petersburg State University, Russia
OTHER