Additional Radiological Methods for Assessing Axillary Lymph Node Involvement in Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Accuracy of Supplementary Imaging for Detecting Axillary Lymph Node Involvement
研究概览
简要总结
Breast cancer frequently spreads to the axillary lymph nodes, and accurate assessment of axillary lymph node involvement is essential for staging and treatment planning. Standard imaging methods may not always reliably determine the extent of axillary disease before treatment.
This study evaluates the usefulness of additional radiological imaging methods for assessing axillary lymph node involvement in patients with breast cancer. The aim is to improve pre-treatment identification of lymph node metastases and to better estimate the extent of axillary disease.
详细描述
Accurate evaluation of axillary lymph node involvement is a key component of breast cancer staging and influences surgical and systemic treatment decisions. Current routine diagnostic methods, including standard ultrasound and other imaging techniques, may have limited sensitivity and specificity in detecting and characterizing axillary lymph node metastases.
This interventional clinical study investigates whether additional radiological imaging methods can improve the assessment of axillary lymph node involvement in breast cancer patients. Participants undergo supplementary radiological examinations of the breast and axilla beyond routine diagnostic procedures. These examinations are performed in order to evaluate the diagnostic performance of additional imaging techniques in determining the presence and extent of axillary lymph node disease.
The study is designed as a prospective cohort study and includes patients diagnosed with breast cancer who are undergoing clinical evaluation and treatment at the Institute of Oncology Ljubljana. The primary objective is to determine whether the additional radiological methods provide improved accuracy for detecting axillary lymph node involvement compared with standard diagnostic assessment.
The results of this study may support improved diagnostic pathways and assist clinicians in selecting the most appropriate therapeutic strategy for breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female patients aged 18 years or older
- •Diagnosed with breast cancer
- •Undergoing diagnostic evaluation and treatment at the Institute of Oncology Ljubljana
- •Ability to provide written informed consent
排除标准
- •Contraindications to contrast-enhanced ultrasound (if applicable)
- •Inability to undergo required imaging procedures
- •Withdrawal of informed consent
研究组 & 干预措施
Breast Cancer Patients Undergoing Additional Axillary Imaging
干预措施: Supplementary Axillary Imaging (Ultrasound Elastography and Contrast-Enhanced Ultrasound) (Diagnostic Test)
结局指标
主要结局
Accuracy of Supplementary Imaging for Detecting Axillary Lymph Node Involvement
时间窗: From baseline imaging assessment until surgery (up to 6 months)
Diagnostic accuracy of supplementary ultrasound-based imaging methods (elastography and contrast-enhanced ultrasound) for identifying axillary lymph node involvement in breast cancer patients, compared with standard clinical and pathological assessment.
次要结局
未报告次要终点