Carbon injection versus metallic marker for marking axillary lymph nodes before surgery
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.
NA · Saint Petersburg State University, Russia · NCT07106112
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Saint Petersburg State University, Russia (other) |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT07106112 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Saint Petersburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Carbon suspension, Axillary lymph node marking, Neoadjuvant therapy, Targeted axillary dissection, Metallic marker