Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer
研究概览
简要总结
The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.
详细描述
The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Biopsy-verified breast cancer
- •Primary tumor more than 2 cm (ultrasound or clinically)
- •The participants must be capable of understanding and giving full informed written consent
排除标准
- •Pregnancy
- •Lactation/breast feeding
- •Weight above 140 kg
- •Treatment with neoadjuvant chemotherapy
- •Known allergy towards the IMP
结局指标
主要结局
Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer
时间窗: 1 hour
Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the presence of metastases in axillary lymph nodes ("spread"/"no spread"). Lymph Node sampling and histopathology determine true positives and true negatives.
次要结局
- Number of axillary lymph node metastasis(1 hour)
- Number of distant metastases(1 hour)
研究者
Dorthe Skovgaard
MD, PhD
Rigshospitalet, Denmark