Phase 3
N=20
Contrast-enhanced MRI in Children 2 Months to <2 Years
Magnetic Resonance Imaging
Bottom Line
View on ClinicalTrials.gov: NCT00937391 ↗Enrolled (actual)
20
Serious AEs
22.2%
Results posted
Oct 2011
Primary outcome: Primary: Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) — 1; 0; 2; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gadopentetate dimeglumine (Magnevist, BAY86-6661) (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Diagnostic Adequacy - Open-label Clinical Investigators (Per Protocol Set) |
1; 0; 2; 3 | — |
| PRIMARY Dose Determined by Blinded Readers to be Superior for Diagnosis |
0; 1; 6; 15; 14; 9 | — |
| PRIMARY Paired-dose Comparison of Number of Participants With Dose Superiority Determined for 4 Lesion Visualization Variables - Blinded Readers |
0; 15; 1; 14; 6; 9 | — |
| PRIMARY PK Analysis - Total Clearance (CL) |
1.012 | — |
| PRIMARY PK Analysis - Total Clearance (CL)/Body Weight (BW) |
0.129 | — |
| PRIMARY PK Analysis - Volume of Distribution at Steady State (Vss) |
1.784 | — |
| PRIMARY PK Analysis - Volume of Distribution at Steady State (Vss) /Body Weight (BW) |
0.232 | — |
| PRIMARY PK Analysis - Area Under the Drug Concentration-time Curve (AUC) |
777.5 | — |
| PRIMARY PK Analysis - t 1/2 |
1.483 | — |
| SECONDARY Number of Participants With Number of Lesions Detected - Stage 1 |
5; 5; 5; 7; 6; 7 | — |
| SECONDARY Number of Participants With Number of Lesions Detected - Stage 2 |
13; 13; 12; 11; 14; 10 | — |
| SECONDARY Number of Participants With Quality of Lesion Visualization - Stage 1 |
4; 7; 9; 3; 6; 8 | — |
| SECONDARY Number of Participants With Quality of Lesion Visualization - Stage 2 |
3; 25; 7; 25; 5; 18 | — |
| SECONDARY Number of Participants With Quality of Border Delineation - Stage 1 |
4; 6; 10; 3; 6; 8 | — |
| SECONDARY Number of Participants With Quality of Border Delineation - Stage 2 |
4; 21; 6; 17; 8; 24 | — |
| SECONDARY Most Frequent Diagnostic Findings With Unenhanced Images - Stage 1 |
4; 7; 8; 6; 8; 6 | — |
| SECONDARY Most Frequent Diagnostic Findings With Unenhanced Images - Stage 2 |
13; 12; 14; 11; 9; 10 | — |
| SECONDARY Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 1 |
6; 6; 1; 0; 6; 6 | — |
| SECONDARY Overall Number of Participants With Change in Diagnosis From Unenhanced to Combined Images - Stage 2 |
10; 6; 10; 8 | — |
| SECONDARY Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 1 |
1; 0; 1; 0; 2; 0 | — |
| SECONDARY Number of Participants With Specific Change in the Diagnosis From Unenhanced to Combined Images - Stage 2 |
1; 1; 2; 2; 1; 1 | — |
| SECONDARY Number of Participants With Diagnostic Confidence - Stage 1 |
1; 0; 0; 3; 0; 0 | — |
| SECONDARY Number of Participants With Diagnostic Confidence - Stage 2 |
3; 0; 3; 1; 1; 0 | — |
| SECONDARY Management Based on Unenhanced Images - Stage 1 |
1; 2; 3; 2; 10 | — |
| SECONDARY Management Based on Unenhanced Images - Stage 2 |
2; 30 | — |
| SECONDARY Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 1 |
5; 12 | — |
| SECONDARY Overall Number of Participants With Change in Management From Unenhanced to Combined Images - Stage 2 |
30 | — |
| SECONDARY Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 1 |
1; 1; 2; 3; 0; 1 | — |
| SECONDARY Number of Participants With Specific Change in Management From Unenhanced to Combined Images - Stage 2 |
3; 16; 3; 3; 7 | — |
Summary
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to < 2 years of age
Eligibility Criteria
Inclusion Criteria
- Age: 2 months to < 2 years (23 months)
- Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI
- Able to comply with the study procedures
Exclusion Criteria
- Clinical unstable participants (eg, intensive care unit)
- Renal Insufficiency
- Participants undergoing chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Magnevist.
Data sourced from ClinicalTrials.gov (NCT00937391). 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.