Carbon injection versus metallic marker for marking axillary lymph nodes before surgery
Official title: A Randomized Trial Comparing Carbon Suspension (Black Eye) and Metallic Markers (TWIRL ULTRACOR) for Localization of Metastatic Axillary Lymph Nodes Prior to Neoadjuvant Systemic Therapy in Breast Cancer Patients.
Run by Saint Petersburg State University, Russia · NCT07106112 · Data updated 2026-11-12
This study will test whether injecting a carbon suspension or placing a small metallic marker helps surgeons find previously cancerous axillary lymph nodes during surgery for women receiving neoadjuvant therapy for breast cancer.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 110 (estimated) |
| Sponsor | Saint Petersburg State University, Russia Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Status | Recruiting |
| Started | May 15, 2025 |
| Main results expected | May 15, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT07106112 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with confirmed T1-3N1M0 breast cancer, ECOG 0-1, and an indication for neoadjuvant therapy who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with persistent N1 after neoadjuvant therapy, progression to distant metastasis, or severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C) are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized 1:1 non-inferiority trial compares ultrasound-guided carbon suspension injection (Black Eye) with ultrasound-guided placement of a metallic marker (TWIRL ULTRACOR) to mark biopsy-proven axillary nodes before neoadjuvant therapy. The primary endpoint is the intraoperative identification rate of the marked lymph node, with secondary endpoints including time from marking to surgery and patient-reported quality of life (EORTC QLQ-BR23). Participants are women with morphologically confirmed T1-3N1M0 breast cancer, randomized to one of the two marking methods and followed for 6 months after surgery. The trial is conducted at a single center in St. Petersburg with blinded surgical identification outcomes.
Why it matters
Potential benefit: If successful, the preferred marking method could improve the reliability of targeted axillary dissection and reduce the need for additional procedures.
How similar studies have gone: Techniques such as carbon tattooing and metallic clip marking have been used in other cohorts with generally good detection rates, but direct randomized comparisons are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
St. Petersburg State University
Saint Petersburg, Russia Recruiting
Study contacts
- Principal investigator: Alina A Olchonova, Physician — Saint Petersburg State University, Russia
- Study coordinator: Alina A Olchonova, Physician
- Email: dr.lazakovich@gmail.com
- Phone: +79818197785
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.