Contrast-enhanced Ultrasound for the Evaluation of Complex Renal Cysts
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- concordance between CEUS and CT
研究概览
简要总结
Complex renal cysts are often incidentally detected on imaging. The differential diagnosis of the complex renal cyst includes various benign cystic lesions, which are based on the Bosniak classification scheme. Currently the standard of care in evaluating a complex renal cyst is using a contrast-enhanced computed tomography (CT) scan, or a contrast-enhanced magnetic resonance imaging (MRI) scan. Since both of these modalities present adverse events due to frequent high doses of radiation, a technique such as a contrast-enhanced ultrasound (CEUS) can be used to obtain the same results, without having to impose high doses of radiation upon a patient.
详细描述
By evaluating complex renal cysts using a contrast-enhanced ultrasound (CEUS), it can be established as to whether or not the results are better, the same, or worse, when compared to CT and/or MRI scans.
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
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old and capable of giving informed consent
- •all patients undergoing CT evaluation of complex renal cysts at our centre (either initially or in follow-up)
- •A complex renal cyst defined as Bosniak IIF, III or IV
排除标准
- •pregnant patients
- •patients with contrast allergies
- •patients with non-cystic, solid renal masses
- •patients with simple cysts (Bosniak class I and II)
结局指标
主要结局
concordance between CEUS and CT
时间窗: (Baseline, follow up at 3, 6, 9, & 12 months)
Complex renal cysts will be classified using the Bosniak classification system for both the CEUS and CT and compared. If surgical removal of a complex cyst is required (Bosniak IIF, III or IV), then the pathology will be evaluated with a single CEUS and a CT (The CEUS will be conducted 14 days within the CT).
次要结局
- histopathological diagnosis after surgery of complex renal cysts(Baseline and every three months until the end of study.)
- Average percent difference of CEUS vs CT imaging(Baseline imaging (CEUS 14 days within a CT scan))
研究者
Anil Kapoor
MD, FRCSC
St. Joseph's Healthcare Hamilton