Phase 1
N=44
Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
Magnetic Resonance Imaging
Bottom Line
View on ClinicalTrials.gov: NCT01544166 ↗Enrolled (actual)
44
Serious AEs
6.8%
Results posted
Nov 2014
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual — 776 micromole*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Gadobutrol (Gadavist, BAY86-4875) (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual |
776 | — |
| PRIMARY Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual |
0.128 | — |
| PRIMARY Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual |
0.277 | — |
| PRIMARY Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual |
2.18 | — |
| PRIMARY Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual |
1.62 | — |
| PRIMARY Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20) |
339 | — |
| PRIMARY Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30) |
292 | — |
| SECONDARY Number of Subjects With Anatomical Area Evaluated |
1; 1; 20; 20; 1; 1 | — |
| SECONDARY Number of Subjects With Technical Adequacy for Diagnosis |
0; 0; 0; 0; 4; 3 | — |
| SECONDARY Number of Subjects With Technical Adequacy for Diagnosis by Body Region |
1; 1; 1; 1; 20; 20 | — |
| SECONDARY Number of Subjects by Overall Contrast Quality |
1; 0; 0; 5; 38 | — |
| SECONDARY Number of Subjects by Overall Contrast Quality by Body Region |
1; 2; 19; 1; 1; 5 | — |
| SECONDARY Number of Subjects With Presence of Pathology |
33; 33; 11; 11 | — |
| SECONDARY Number of Subjects With Presence of Pathology by Body Region |
0; 0; 1; 1; 10; 10 | — |
| SECONDARY Number of Subjects With Number of Lesions Detected |
2; 1; 29; 29; 2; 2 | — |
| SECONDARY Number of Subjects With Number of Lesions Detected by Body Region |
1; 1; 10; 10; 1; 1 | — |
| SECONDARY Contrast Enhancement in Lesion or Vessel |
44; 3; 0; 0; 0; 6 | — |
| SECONDARY Contrast Enhancement in Lesion or Vessel by Body Region |
1; 1; 2; 0; 0; 2 | — |
| SECONDARY Number of Subjects With Border Delineation of Lesion of Vessel |
5; 1; 6; 0; 9; 1 | — |
| SECONDARY Number of Subjects With Border Delineation of Lesion of Vessel by Body Region |
1; 1; 2; 2; 3; 0 | — |
| SECONDARY Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement |
6; 1; 11; 0; 27; 43 | — |
| SECONDARY Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region |
1; 1; 2; 2; 1; 0 | — |
| SECONDARY Number of Subjects With Diagnoses |
1; 2; 4; 4; 1; 1 | — |
| SECONDARY Number of Subjects With Diagnoses by Body Region |
1; 1; 1; 1; 1; 1 | — |
| SECONDARY Number of Subjects With Additional Diagnostic Gain |
19; 24; 1 | — |
| SECONDARY Number of Subjects With Additional Diagnostic Gain by Body Region |
1; 11; 9; 1; 2; 3 | — |
| SECONDARY Number of Subjects With Confidence in Diagnosis |
6; 1; 14; 3; 24; 40 | — |
| SECONDARY Number of Subjects With Confidence in Diagnosis by Body Region |
1; 1; 1; 0; 8; 0 | — |
| SECONDARY Number of Subjects With Final Diagnosis |
24; 6; 6; 4; 2; 1 | — |
| SECONDARY Number of Subjects With Final Diagnosis by Body Region |
1; 3; 1; 1; 6; 2 | — |
| SECONDARY Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI |
39; 5 | — |
| SECONDARY Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region |
1; 0; 20; 1; 2; 0 | — |
| SECONDARY Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis |
33; 11 | — |
| SECONDARY Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region |
1; 0; 17; 4; 1; 1 | — |
| SECONDARY Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis |
32; 12 | — |
| SECONDARY Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region |
1; 0; 16; 5; 1; 1 | — |
| SECONDARY Number of Subjects With Change in Management From Unenhanced to Combined MRI |
36; 8 | — |
| SECONDARY Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region |
1; 0; 19; 2; 2; 0 | — |
| SECONDARY Number of Subjects With Clinically Significant Abnormal Laboratory Values |
— | — |
| SECONDARY Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection |
61.8; 91.7; 136.3; 115.2; 150.4 | — |
Summary
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol.
A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.
Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate <80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.
The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.
Eligibility Criteria
Inclusion Criteria
- Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)
- Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region
Exclusion Criteria
- Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
- Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
- Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
- Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
- Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
- History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
- Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate <80% of age adjusted normal value calculated based on the Schwartz formula
Data sourced from ClinicalTrials.gov (NCT01544166). 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.