check_circleStudy Completed
Magnetic Resonance Imaging
Bayer Identifier:
91741
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Gadobutrol pharmacokinetic and safety study in pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)
Trial purpose
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.
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.
Key Participants Requirements
Sex
BothAge
NaN - 2 YearsTrial summary
Enrollment Goal
44Trial Dates
May 2012 - November 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dresden, 01307, Germany | |
Completed | Halle, 06097, Germany | |
Completed | Jena, 07740, Germany | |
Completed | Edmonton, T6G 2B7, Canada | |
Withdrawn | New York, 10032, United States | |
Withdrawn | Atlanta, 30342-1605, United States | |
Completed | Houston, 77030, United States | |
Completed | Cincinnati, 45229, United States | |
Completed | Boston, 02111, United States | |
Completed | Chicago, 60611, United States | |
Completed | Savannah, 31406, United States |
Primary Outcome
- Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individualdate_rangeTime Frame:Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrolenhanced_encryptionNoSafety Issue:
- Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individualdate_rangeTime Frame:Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrolenhanced_encryptionNoSafety Issue:
- Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individualdate_rangeTime Frame:Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrolenhanced_encryptionNoSafety Issue:
- Mean Residence Time (MRT) of Gadobutrol in Plasma: Individualdate_rangeTime Frame:Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrolenhanced_encryptionNoSafety Issue:
- Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individualdate_rangeTime Frame:Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrolenhanced_encryptionNoSafety Issue:
- Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)date_rangeTime Frame:20 minutes post-injectionenhanced_encryptionNoSafety Issue:
- Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)date_rangeTime Frame:30 minutes post-injectionenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of Subjects With Anatomical Area Evaluateddate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Technical Adequacy for Diagnosisdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Technical Adequacy for Diagnosis by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects by Overall Contrast Qualitydate_rangeTime Frame:Images were taken post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects by Overall Contrast Quality by Body Regiondate_rangeTime Frame:Images were taken post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects with Presence of Pathology by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Number of Lesions Detecteddate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Number of Lesions Detected by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Contrast Enhancement in Lesion or Vesseldate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Contrast Enhancement in Lesion or Vessel by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Border Delineation of Lesion of Vesseldate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Border Delineation of Lesion of Vessel by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects by Lesion Characterization or Homogeneity of Vessel Enhancementdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects by Lesion Characterization or Homogeneity of Vessel Enhancement by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Diagnosesdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Diagnoses by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects with Additional Diagnostic Gaindate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects with Additional Diagnostic Gain by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects with Confidence in Diagnosisdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects with Confidence in Diagnosis by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Final Diagnosisdate_rangeTime Frame:Up to 4 weeks post-injectionenhanced_encryptionNoSafety Issue:
- Number of Subjects With Final Diagnosis by Body Regiondate_rangeTime Frame:Up to 4 weeks post-injectionenhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRIdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosisdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosisdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Management From Unenhanced to Combined MRIdate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Regiondate_rangeTime Frame:Images were taken pre-injection and post-injection (within about 15 minutes)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Clinically Significant Abnormal Laboratory Valuesdate_rangeTime Frame:Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injectionenhanced_encryptionYesSafety Issue:
- Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injectiondate_rangeTime Frame:Before gadobutrol injectionenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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