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Carbon Suspension vs. Metallic Marker for Axillary Lymph Node Marking in Breast Cancer After Neoadjuvant Therapy

RECRUITINGN/ASponsored by Saint Petersburg State University, Russia
Actively Recruiting
PhaseN/A
SponsorSaint Petersburg State University, Russia
Started2025-05-15
Est. completion2026-05-15
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07106112

Summary

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).

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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).

Conditions2

Breast CancerCancer

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