Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
Recruiting · NCT07106112 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Ultrasound-guided carbon suspension (Black Eye) injectionUltrasound-guided metallic marker (TWIRL ULTRACOR) placement
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).
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women ≥18 years.
- Morphologically confirmed breast cancer (T1-3N1M0).
- ECOG 0-1.
- Indication for neoadjuvant therapy.
- Signed informed consent.
Exclusion criteria
- No lymph node regression post-neoadjuvant therapy (persistent N1).
- Distant metastasis progression.
- Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).
Where it is running
1 location listed.
- St. Petersburg State University - Saint Petersburg, Russia