EUCTR2006-004153-22-DK进行中（未招募）不适用
Open-label multi-center study of magnetic resonance imaging (MRI) with 0.1 mmol/kg BW Gadovist (1.0 M) to assess pharmacokinetics, safety and tolerability in children
Bayer AB, Bayer Schering Pharma0 个研究点目标入组 140 人开始时间: 2007年4月16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
- 入组人数
- 140
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
- •Patients must fulfill the following inclusion criteria:
- •1.1.Patient is of specific age group, i.e.
- •Age group I: 2 - 6 years
- •Age group II: 7 - 11 years
- •Age group III: 12 - 17 years
- •2. Patient is scheduled to undergo routine Gd-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view only)
- •3. Patient is able and willing to undergo the study MRI/MRA procedure with Gadovist
- •4. Patient is willing to comply with the study procedures (e.g. being followed-up for 24 (+/- 4) hours after the Gadovist injection)
- •5. Fully informed written consent of parent(s)/ legal representative(s)
- •6. Following informed consent by parent(s)/ legal representative(s), assent (as regarded as appropriate according to the opinion of the pediatrician and/or investigator) for active study participation is obtained based on age-appropriate trial information.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients are to be excluded from the study if they meet any of the following exclusion criteria:
- •1. Clinically unstable patient, e.g. patient in whom fluctuations in safety parameters may be observed during the study period due to underlying disease and/or respective treatment regiments (e.g. polytrauma patients, intensive care unit)
- •2. Patient undergoing a change in chemotherapy = 48 hours prior to and up to 24 hours after administration of Gadovist
- •3. Any planned intervention during the study and up to 24 hours after administration of Gadovist
- •4. Patient who has received or will receive any investigational drug 48 hours before MR-examination or during study participation.
- •5. Patient having received any other contrast agent within 30 hours prior to injection of Gadovist or likely to receive one during the 24-hour follow-up period
- •6. Patient presenting with contraindication for MRI, e.g. pacemaker, iron metal implants (e.g. aneurysm clips) or severe claustrophobia
- •7. Patient presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
- •8. Severe inborn or acquired heart rhythm anomalies
- •9. Congenital long QT syndrome or family history of congenital long QT syndrome
- •10. Any medication that is known to prolong the QT interval
- •11. Uncorrected hypokalemia
- •12. Congenital heart defect or higher degree valvular pathology
- •13. Patient with renal insufficiency (i.e glomerular filtration rate (GFR) < 80% of age-adjusted normal value)
- •14. Patient with known and clinically relevant (e.g. more than 3 times upper limit of reference range) deviations of available clinical laboratory parameters from reference ranges, in particular with regard to liver / renal function and blood coagulation
- •15. Female adolescent who is pregnant or lactating
- •16. Female adolescent who is of childbearing potential and has not had a negative urine pregnancy test the same day as administration of Gadovist. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
- •17. Previous participation in this study
- •18. Close affiliation with the investigational site; e.g. a close relative of the investigator
- •19. Child in institutionalized care (most vulnerable population)
- •20. Severely mentally or emotionally handicapped child according to the investigators opinion
研究者
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