Actively Recruiting
Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
Led by Saint Petersburg State University, Russia · Updated on 2025-08-06
110
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Morphologically confirmed breast cancer stage T1-3N1M0
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Indication for neoadjuvant therapy
- Signed informed consent form
You will not qualify if you...
- No lymph node regression after neoadjuvant therapy (persistent N1)
- Progression of distant metastases
- Severe comorbid conditions including NYHA class III-IV heart failure, COPD GOLD D, or Child-Pugh class C liver disease
AI-Screening
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Trial Site Locations
Total: 1 location
1
St. Petersburg State University
Saint Petersburg, Russia
Actively Recruiting
Research Team
A
Alina A Olchonova, Physician
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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