Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
研究概览
简要总结
This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
详细描述
PRIMARY OBJECTIVES:
I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.
OUTLINE:
Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.
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
- •Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
- •Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30)
- •Any disease type
排除标准
- •Pregnant women
- •Patients with impaired renal function (eGFR < 30)
- •Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
- •Patients with contraindications to the use of intravenous contrast such as allergic type reactions
研究组 & 干预措施
Diagnostic (contrast-enhanced MRI)
Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.
干预措施: Gadobutrol (Drug)
Diagnostic (contrast-enhanced MRI)
Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.
干预措施: Contrast-enhanced Magnetic Resonance Imaging (Procedure)
Diagnostic (contrast-enhanced MRI)
Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.
干预措施: Gadoxetate Disodium (Drug)
结局指标
主要结局
Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
时间窗: Up to 4 years
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.
次要结局
未报告次要终点