Evaluation of Complex Renal Cystic Lesions With Contrast Enhanced Ultrasound (CEUS) and Functional MRI Versus the Gold Standard: Computer Tomography (CT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- CRC classification according to CT-finding based on Bosniak criteria or until surgical intervention
研究概览
简要总结
The primary concern in complex renal cysts (CRC) with malignant potential is the accurate diagnosis and characterization. Patients with CRC have to undergo frequent imaging surveillance (every 6-12 Mo), in which the progression suggests a neoplastic process. The gold standard for establishing diagnosis and necessity for surgical intervention (i.e. partial nephrectomy) is conventional computer tomography (CT) imaging. Its main drawback is the radiation dose to the body and intravenous contrast media administration, which has a risk of nephrotoxicity.
Magnetic resonance imaging (MRI) with special functional sequences (fMRI) and contrast-enhanced ultrasonography (CEUS) allow measuring tissue blood flow and perfusion characteristics without ionizing radiation or nephrotoxic contrast media. To compare the diagnostic accuracy, sensitivity and specificity of CEUS/functional MRI versus the gold standard CT, 60 patients with CRC will be evaluated using all these 3 modalities. The main hypothesis is that fMRI and CEUS have equal accuracy with CT regarding diagnosis and classification of CRC lesions.
详细描述
Background
Renal cysts occur in a variety of diseases but also in normal kidneys (i.e. simple cysts). Diagnostic imaging plays a central role in the diagnosis of renal cysts and lesions. Most patients are diagnosed after undergoing imaging (computed tomography [CT], magnetic resonance imaging [MRI], ultrasound [US]) for an unrelated reason and their increasing incidental finding during the last decade parallels the growing use of imaging procedures.
Simple renal cysts are commonly observed in normal kidneys and are of limited clinical relevance. The primary clinical concern is the accurate evaluation of complex renal cysts (CRC) that have a malignant potential. Based upon the initial radiographic evaluation, further studies may be required, and some complex lesions may require surgical excision for exact diagnosis, based on growth during follow up.
The gold standard for the diagnosis of CRC is conventional CT imaging. Its main drawback is the radiation dose to the body and intravenous contrast media administration, which has a risk of nephrotoxicity. In order to accurate classify and manage these lesions, the Bosniak renal cyst classification system was created. Based upon morphologic and enhancement characteristics of the CT scan, cystic renal masses are placed in one of five categories (I, II, IIF, III, IV).
Although not yet validated for reader agreement or generalizability, the Bosniak renal cyst classification system has been widely accepted by urologists and radiologists as the best way to assess and follow these CRC lesions. While the Bosniak classification is based on CT findings, the same approach is applicable as a useful predefined framework for the evaluation of CRC with other radiographic modalities i.e. with MRI and conventional or contrast-enhanced ultrasound. The ability to differentiate between those that are benign versus malignant (surgical versus nonsurgical masses) still represents a major challenge.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years old
- •Written informed consent
- •A complicated renal cyst (Bosniak category > II cyst or hemorrhagic cyst) or lesion > 1 cm im max. transverse diameter who will undergo standard renal CT imaging
- •Stable renal function (GFR> 30 ml/min/1.73 m2)
- •Exclusion Criteria
- •Pregnancy
- •History of allergic reaction to contrast agents
- •Refusal to adhere to follow-up
- •Recent pyelonephritis
- •Acute kidney injury (AKI stage ≥ 1)
- •Other individuals especially in need of protection (according to the Swiss Academy of Medical Sciences)
排除标准
- 未提供
结局指标
主要结局
CRC classification according to CT-finding based on Bosniak criteria or until surgical intervention
时间窗: 1 year
次要结局
- Diagnostic accuracy of CEUS and fMRI based on the progression of CRC according to CT-finding and Bosniak classification throughout visit 1-2(1 year)
- Diagnostic accuracy of CEUS and fMRI based on surgical extraction and histopathological evaluation of the resected mass(1 year)