EUCTR2009-011095-30-DE进行中（未招募）1 期
Intra-individual comparison of Gd-EOB-DTPA disodium (Primovist) and Gadobutrol (Gadovist) in patients with suspicion of hepatocellular carcinoma - Primovist® in HCC
Medizinische Fakultät Mannheim, Ruprecht-Karls-Universität Heidelberg0 个研究点目标入组 42 人开始时间: 2009年7月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
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
- •1.Liver lesion, suspicion of hepatocellular carcinoma
- •2.Having received Gadovist®-enhanced MRI of the liver for clinical reasons
- •3.Age: 18-80 years
- •4.Willing to comply with the study procedures
- •5.Patients who have given their fully informed and written consent voluntarily
- •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
- •1.If female, of childbearing potential
- •2.GFR <50 mL/min/1.73m² (MDRD or Cockroft-Gault formula), values =4 weeks
- •3.Not being able to remain lying down for at least 45-60 min (e.g., patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain)
- •4.Known allergy to any ingredient of Primovist®
- •5.Any contraindication for Primovist® (according to SmPC)
- •6.Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
- •7.Being clinically unstable
- •8.Having any contraindication to MRI examination (e.g., pacemaker, recent wound clips, and severe claustrophobia).
- •9.Having any physical or mental status that interferes with the informed consent procedure including self-signed consent
- •10.Close affiliation with the investigational site; e.g. a close relative of the investigator
- •11.Having been previously enrolled in this study
- •12.Participating in another clinical trial
研究者
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