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

Saint Petersburg State University, Russia

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: Ultrasound-guided carbon suspension (Black Eye) injection; Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07106112

05/45

Details and patient eligibility

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).

Full description

Interventions:

Group 1: Ultrasound-guided injection of 0.5 mL carbon suspension (Black Eye). Group 2: Ultrasound-guided placement of a metallic marker (TWIRL ULTRACOR). Follow-up: 6 months post-surgery. Design: Randomized 1:1, non-inferiority trial.

Enrollment: 110 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Carbon Suspension (Black Eye) Marking

Experimental group

Treatment:

Procedure: Ultrasound-guided carbon suspension (Black Eye) injection

Metallic Marker (TWIRL ULTRACOR) Placement

Active Comparator group

Treatment:

Procedure: Ultrasound-guided metallic marker (TWIRL ULTRACOR) placement