Phase 1
N=140
A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
Magnetic Resonance Imaging
Bottom Line
View on ClinicalTrials.gov: NCT00468819 ↗Enrolled (actual)
140
Serious AEs
1.5%
Results posted
Sep 2011
Primary outcome: Primary: Plasma Clearance Estimates of Gadobutrol by Age Group — 2.07; 3.28; 4.90; 3.24 L/h
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gadobutrol (Gadavist, Gadovist, BAY86-4875) (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Clearance Estimates of Gadobutrol by Age Group |
2.07; 3.28; 4.90; 3.24 | — |
| PRIMARY Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group |
0.13; 0.10; 0.09; 0.10 | — |
| PRIMARY Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group |
3.83; 5.98; 10.02; 5.96 | — |
| PRIMARY Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group |
0.24; 0.19; 0.18; 0.20 | — |
| PRIMARY Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group |
815; 969; 1167; 999 | — |
| PRIMARY Terminal Elimination Half Life Estimates of Gadobutrol by Age Group |
1.75; 1.61; 1.65; 1.69 | — |
| PRIMARY Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group |
1.88; 1.83; 2.03; 1.94 | — |
| SECONDARY Urinary Excretion of Gadolinium as Percent of Administered Dose |
93.78; 92.14; 95.96; 94.13 | — |
| SECONDARY Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pre-Contrast Lesions by Location and by Age Group |
5; 0; 8; 13; 0; 0 | — |
| SECONDARY Post-Contrast Lesions by Location and by Age Group |
6; 0; 5; 11; 0; 0 | — |
| SECONDARY Pre-Contrast Delineation of Lesion/Vessel Border by Age Group |
3; 0; 1; 4; 5; 0 | — |
| SECONDARY Post-Contrast Delineation of Lesion/Vessel Border by Age Group |
0; 0; 5; 5; 0; 4 | — |
| SECONDARY Pre-Contrast Lesion Characterization by Age Group |
3; 1; 2; 6; 6; 6 | — |
| SECONDARY Post-Contrast Lesion Characterization by Age Group |
1; 0; 6; 7; 2; 3 | — |
| SECONDARY Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions) |
19; 19; 18; 56; 1; 1 | — |
| SECONDARY Number of Participants With Change in Diagnostic Confidence by Age Group |
0; 0; 1; 1; 3; 3 | — |
Summary
In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.
Eligibility Criteria
Inclusion Criteria
- Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).
Exclusion Criteria
- Clinically unstable patients (e.g. intensive care unit)
- Renal insufficiency
- Patients undergoing a relevant change in chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Gadovist.
Data sourced from ClinicalTrials.gov (NCT00468819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.