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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Intraoperative detection rate of marked lymph nodes (%)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥18 years.
- •Morphologically confirmed breast cancer (T1-3N1M0).
- •Indication for neoadjuvant therapy.
- •Signed informed consent.
排除标准
- •No lymph node regression post-neoadjuvant therapy (persistent N1).
- •Distant metastasis progression.
- •Severe comorbidities (NYHA III-IV, COPD GOLD D, Child-Pugh C).
结局指标
主要结局
Intraoperative detection rate of marked lymph nodes (%)
时间窗: Assessed intraoperatively (day of surgery).
The proportion of successfully identified and excised marked lymph nodes during surgery, confirmed by visual (carbon suspension) or imaging/metallic detection (metallic marker)
次要结局
- Time from Marking to Surgery (Days)(From the date of marking procedure (Day 0) to the date of surgery (up to 12 weeks post-marking))
- Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module [EORTC QLQ-BR23] Scores(1. Baseline (pre-marking), 2. Post-neoadjuvant therapy (pre-surgery) 3. 1-month postoperatively.)
研究者
Alina Olchonova
Principal Investigator
Saint Petersburg State University, Russia