check_circleStudy Completed
Magnetic Resonance Imaging
Bayer Identifier:infoA unique number for a trial given by Bayer.
91741
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
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 info
44The overall number of participants needed for a trial.
Trial Dates info
May 2012 - November 2013Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 1A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Gadavist/Gadovist (Gadobutrol, BAY86-4875)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where 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 OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- 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 OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- 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 info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
DiagnosticThe main reason the clinical trial is being done.
Allocation info
Non-randomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
Open Label“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Single Group AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
1A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.
Additional Information
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