NL-OMON36761已完成4 期
Primovist enhanced MRI for the detection and evaluation of focal liver lesions - PRIDE-study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 230 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1) Suspicion of focal liver lesions, both benign and malignant
- •2) Age > 18 years
排除标准
- •- clinical query on liver MRI chart directed to other liver disease than focal liver lesions like cirrhosis, hepatitis or liver abces
- •- previous liver surgery
- •- a pacemaker
- •- administration of a liver specific contrast agent within 2 weeks prior to the first MRI with Primovist
- •- claustrophobia
- •- hypersensitivity to active substance or any of the recipients of Gd-EOB-DTPA contrast
- •- caution should be exercised in patients with clinically severe cardiovascular disease. myocardial infarction, uncontrolled hypertensia, instable angina pectoris, congestive hert failure, uncontrolled arhythmia's requiring medication
- •- severe kidney failure (creatinin clearance <30ml/min)
- •- pregnancy or lactating women
- •- high plasma concentration of rifampicin (inhbitor of Gd-EOB-DTPA uptake)
研究者
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