Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)

November 26, 2020 updated by: Bayer

Open-label, Multicenter, Pharmacokinetic, and Safety Study in Children (Term Newborn Infants to 23 Months of Age) Undergoing a Contrast-enhanced MRI With an Intravenous Injection of 0.1 mmol/kg BW Gadobutrol 1.0 M

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
  • Germany
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06097
    • Thüringen
      • Jena, Thüringen, Germany, 07740
  • United States
    • Georgia
      • Savannah, Georgia, United States, 31406
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Ohio
      • Cincinnati, Ohio, United States, 45229
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Overall study
Drug: Gadobutrol (Gadavist, BAY86-4875)
Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual
Time Frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole*hour per liter (micromole*h/L).
Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual
Time Frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h*kg).
Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual
Time Frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual
Time Frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.
Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual
Time Frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.
Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)
Time Frame: 20 minutes post-injection
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
20 minutes post-injection
Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)
Time Frame: 30 minutes post-injection
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
30 minutes post-injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Anatomical Area Evaluated
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Technical Adequacy for Diagnosis
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Technical Adequacy for Diagnosis by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects by Overall Contrast Quality
Time Frame: Images were taken post-injection (within about 15 minutes)
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
Images were taken post-injection (within about 15 minutes)
Number of Subjects by Overall Contrast Quality by Body Region
Time Frame: Images were taken post-injection (within about 15 minutes)
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
Images were taken post-injection (within about 15 minutes)
Number of Subjects With Presence of Pathology
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as "yes/no". The number of lesions identified for each MRI set was recorded.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Presence of Pathology by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as "yes/no". The number of lesions identified for each MRI set was recorded. Results per body region were reported.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Number of Lesions Detected
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Presence of pathology included presence of lesions and was recorded as "yes/no". If "yes" the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Number of Lesions Detected by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Presence of pathology included presence of lesions and was recorded as "yes/no". If "yes" the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported.
Images were taken pre-injection and post-injection (within about 15 minutes)
Contrast Enhancement in Lesion or Vessel
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Contrast Enhancement in Lesion or Vessel by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Border Delineation of Lesion of Vessel
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Border Delineation of Lesion of Vessel by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Diagnoses
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Diagnoses by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Additional Diagnostic Gain
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Additional Diagnostic Gain by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Confidence in Diagnosis
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Confidence in Diagnosis by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Final Diagnosis
Time Frame: Up to 4 weeks post-injection
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.
Up to 4 weeks post-injection
Number of Subjects With Final Diagnosis by Body Region
Time Frame: Up to 4 weeks post-injection
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.
Up to 4 weeks post-injection
Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The analysis value for change in diagnosis was recorded as "yes/no". Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The analysis value for change in diagnosis was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Management From Unenhanced to Combined MRI
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as "yes/no". Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region
Time Frame: Images were taken pre-injection and post-injection (within about 15 minutes)
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as "yes/no". Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Images were taken pre-injection and post-injection (within about 15 minutes)
Number of Subjects With Clinically Significant Abnormal Laboratory Values
Time Frame: Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection
Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.
Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection
Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection
Time Frame: Before gadobutrol injection
eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k * height / Scr where k = 0.45 in term newborn infants < 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413*height/Scr.
Before gadobutrol injection

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Drug Related Serious and Non- Serious Adverse Events
Time Frame: From baseline to approximately 7 days after injection
An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a "reasonable causal relationship" to the study treatment.
From baseline to approximately 7 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

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Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

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Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91741
  • 2010-023003-96 (EudraCT Number)

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Clinical Trials on Magnetic Resonance Imaging

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