Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
NCT ID: NCT07106112
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2025-05-15
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Carbon Suspension (Black Eye) Marking
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.
Metallic Marker (TWIRL ULTRACOR) Placement
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Morphologically confirmed breast cancer (T1-3N1M0).
* ECOG 0-1.
* Indication for neoadjuvant therapy.
* Signed informed consent.
Exclusion Criteria
* Distant metastasis progression.
* Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).
18 Years
FEMALE
No
Sponsors
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Saint Petersburg State University, Russia
OTHER
Responsible Party
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Alina Olchonova
Principal Investigator
Principal Investigators
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Alina A Olchonova, Physician
Role: PRINCIPAL_INVESTIGATOR
Saint Petersburg State University, Russia
Locations
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St. Petersburg State University
Saint Petersburg, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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05/45
Identifier Type: -
Identifier Source: org_study_id
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