EUCTR2009-012115-18-NL进行中（未招募）不适用
Primovist enhanced MRI for the detection and evaluation of focal liver lesions - PRIDE-study
MC Utrecht0 个研究点开始时间: 2010年3月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- age > 18 years
- •- suspicion of focal liver lesions, both benign and/or malignant:
- •- Haemangioma
- •- Focal Nodular Hyperplasia
- •- Cystadenoma
- •- Metastasis
- •- Hepatocellular Carcinoma (HCC)
- •- Cholangiocarcinoma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- primary clinical query on the liver MRI chart: liver cirrhosis, hepatitis, steatosis, or liver abscess, or any other liver disease not defined as focal disease.
- •- previous liver surgery
- •- a pacemaker
- •- severe renal disease (creatinin clearance <30ml/min or haemodialysis is necessary)
- •- administration of a liver specific contrast agent within 2 weeks prior to the first MRI with Primovist.
- •- claustrophobia
- •- hypersensitivity to the active substances or any of the recipients of Gd-EOB-DTPA contrast:
- •- previous reaction to contrast media
- •- history of bronchial asthma
- •- history of allergic disorders causing anaphylactic shock
- •- caution should be exercised in patients with clinically severe cardiovascular disease. Myocardial infarction, uncontrolled hypertension, instable angina pectoris, congestive heart failure, uncontrolled arrhythmia’s requiring medication
- •- pregnancy or lactating women (in case of uncertainty, a pregnancy test will be performed)
- •- treatment with rifampicin (inhibitor of Gd-EOB-DTPA uptake)
研究者
相似试验
已完成
4 期
Primovist enhanced MRI for the detection and evaluation of focal liver lesionsfocal liver lesionfocal liver tumor10019815NL-OMON36761niversitair Medisch Centrum Utrecht230
撤回
4 期
Primovist enhanced MRI for the detection and evaluation of focal liver lesionsfocal liver lesionfocal liver tumor10019815NL-OMON33584niversitair Medisch Centrum Utrecht125
招募中
不适用
PRIDE-study.focal liver lesionsNL-OMON24607Dr. R. van Hillegersberg, SurgeonCoordinating Investigator/Project leader/Principal Investigator:University Medical Center UtrechtHeidelberglaan 100, 3584 CX Utrecht,The Netherlands230
招募中
不适用
Advanced MRI techniques and biomarkers to substitute gadolinium enhanced MRI for the detection of disease activity in multiple sclerosis.10007951Multiple SclerosisNL-OMON53657Amsterdam UMC75
尚未招募
不适用
Validation of MRI with Primovist® for Differentiation of Hepatocellular Adenoma and Focal Nodular Hyperplasiabenign livertumours1001981510019813NL-OMON31336Academisch Medisch Centrum100