Non-invasive Axillary Lymph Node Staging in Breast Cancer With PET-MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Accuracy of dedicated hybrid PET/MRI
研究概览
简要总结
Axillary lymph node status is an important prognostic factor for patients with breast cancer. After breast cancer diagnosis, current nodal staging consists of axillary ultrasound (US) combined with tissue sampling when deemed necessary. In case of positive axillary lymph nodes, patients will undergo axillary lymph node dissection (ALND). In case of no suspicious axillary lymph nodes (i.e. clinically node negative patients), patients will undergo sentinel lymph node biopsy (SLNB). This surgical nodal staging is accompanied by co-morbidity. In theory, if non-invasive imaging can evaluate the lymph node status accurately, a node negative patient would no longer have to undergo axillary surgery. Since MRI is suitable for soft tissue imaging and PET has the advantage of showing increased metabolic uptake in lymph node metastases, a combination of these techniques in hybrid PET/MRI would be highly desirable. If dedicated axillary hybrid PET/MRI is equally accurate to SLNB for the detection of negative axillary lymph nodes, work-up could be more efficient by bypassing SLNB. However, the accuracy of dedicated axillary hybrid PET/MRI needs to be compared with the pathological outcome of SLNB (gold standard) first.
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 patient with histologically confirmed breast cancer and clinically confirmed negative lymph nodes in the axilla, scheduled to undergo SLNB
- •Patients who are willing and able to undergo the study procedures
- •The patient has provided personally written informed consent
排除标准
- •Patients treated with neoadjuvant systemic therapy prior to axillary nodal staging
- •Patients with clinically positive axillary lymph nodes
- •Age < 18 years
- •Inability to provide informed consent
- •Weight >100 kg (because of the format of the PET/MRI scanner)
- •General contraindications for MRI (such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia) or PET (i.e. known allergy to 18F-FDG)
- •Hyperglycaemia (> 11 mmol/L) at the time of 18F-FDG injection
结局指标
主要结局
Accuracy of dedicated hybrid PET/MRI
时间窗: Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks
Accuracy (sensitivity, negative predictive value (NPV) and false negative rate (FNR)) of dedicated axillary hybrid PET/MRI to exclude axillary lymph node metastases will be calculated.
次要结局
- Accuracy of T2w MRI, DWI and Hybrid PET/MRI(Participants will be followed from the moment of first outpatient clinic visit until final breast surgery, an expected average of 4 weeks)