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 childre

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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