Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy
Recruiting
N/A
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 110 (estimated)
- Sponsor
- Saint Petersburg State University, Russia · Other
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About This Trial
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).
Trial Locations
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Eligibility 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.
* Se…
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