A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children

June 29, 2015 updated by: Bayer

Open-label Multi-center Study of Magnetic Resonance Imaging (MRI) With 0.1 mmol/kg Body Weight (BW) Gadavist (1.0 M) to Assess Pharmacokinetics, Safety and Tolerability in Children.

In this clinical study a contrast agent for magnetic resonance imaging (MRI), which has already been approved for application in adults, will be investigated in children and adolescents. MRI is a modern and safe examination method without delivering radiation burden using magnetic fields to produce cross-sectional images of the human body. A special computer program then puts these images together and creates a two or three-dimensional image of the inner organs thus facilitating the detection and evaluation of pathological changes. In contrast-enhanced MRI a contrast agent is injected into a peripheral vein before the examination which results in a stronger contrast in the examined area. Therefore, pathological changes can be more easily detected and evaluated compared to non-enhanced MRI. The company Bayer HealthCare Pharmaceuticals has developed a contrast agent for MRI called Gadavist 1.0 which was first approved in 1998 in Switzerland for MRI of brain and spine. Since 2003 Gadavist can also be used in magnetic resonance angiography (MRA) in adults, i.e. in the MRI examination of the blood vessels and since 2006 in MRI of liver and kidney disease. Gadavist was examined in more than 2,900 adults within the framework of clinical studies during development and has been used after its marketing authorization in meanwhile more than 600,000 patients. Yet, clinical studies investigating Gadavist have been only conducted with adults so far. Diseases requiring MRI examinations, however, often occur in children, too. Therefore, many contrast agents are already used on a regular basis in MRI examinations of children, some of these contrast agents being authorized already. Within the framework of this study the pharmacokinetic characteristics of Gadavist in children or adolescents will be investigated, i.e. how the contrast agent is distributed and behaves in the body. In addition, safety and tolerability will be evaluated in order to demonstrate that Gadavist 1.0 is a safe and well tolerated contrast agent also for children and adolescents. Furthermore, the study aims to obtain the dosage recommendation of 0.1 ml per kilogram body weight also for this population group.

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.

Detailed Description

Please note that the present study is allocated two study phases, i.e. phase I and phase III.

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.
140

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

  • Austria
      • Wien, Austria, 1090
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
  • Germany
    • Bayern
      • Erlangen, Bayern, Germany, 91054
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53105
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04103
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
      • Kiel, Schleswig-Holstein, Germany, 24103
    • Thüringen
      • Jena, Thüringen, Germany, 07740
  • Sweden
      • Göteborg, Sweden, 41485
      • Stockholm, Sweden, 17176
      • Uppsala, Sweden, 75185

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

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (male/ female) of specific age groups (2-6 years, 7-11 years, 12-17 years) who are scheduled to undergo Gadolinium (Gd)-enhanced MRI of brain, spine, liver and/or kidneys or Gd-enhanced MRA (single field of view).

Exclusion Criteria:

  • Clinically unstable patients (e.g. intensive care unit)
  • Renal insufficiency
  • Patients undergoing a relevant change in chemotherapy </= 48 hours prior to and up to 24 hours after the administration of Gadovist.

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: Gadobutrol (Gadavist, BAY86-4875) - age 2 to 6 years
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
Experimental: Gadobutrol (Gadavist, BAY86-4875) - age 7 to 11 years
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
Experimental: Gadobutrol (Gadavist, BAY86-4875) - age 12 to 17 years
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
Experimental: Gadobutrol (Gadavist, BAY86-4875) - age 2 to 17 years
Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection

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
Plasma Clearance Estimates of Gadobutrol by Age Group
Time Frame: From injection of Gadobutrol up to 8 hours after injection.
Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.
From injection of Gadobutrol up to 8 hours after injection.
Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group
Time Frame: From injection up to 8 hours after Gadobutrol injection
Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.
From injection up to 8 hours after Gadobutrol injection
Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
Time Frame: From injection up to 8 hours after Gadobutrol injection
Apparent volume of distribution at steady state expressed in L after intravenous injection.
From injection up to 8 hours after Gadobutrol injection
Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
Time Frame: From injection to 8 hours after Gadobutrol injection
Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.
From injection to 8 hours after Gadobutrol injection
Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group
Time Frame: From injection to 8 hours after Gadobutrol injection
Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L.
From injection to 8 hours after Gadobutrol injection
Terminal Elimination Half Life Estimates of Gadobutrol by Age Group
Time Frame: From injection to 8 hours after Gadobutrol injection
Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.
From injection to 8 hours after Gadobutrol injection
Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group
Time Frame: From injection to 8 hours after Gadobutrol injection
Mean residence time of Gadobutrol in plasma expressed in h.
From injection to 8 hours after Gadobutrol 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
Urinary Excretion of Gadolinium as Percent of Administered Dose
Time Frame: up to 6 hours after Gadobutrol injection
Amount of gadolinium* excreted into urine during the collection interval 0 - 6 h post dose expressed as % of administered dose. *A metallic rare-earth element, used as a contrast medium for magnetic resonance imaging.
up to 6 hours after Gadobutrol injection
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
Time Frame: Up to 1 hour after Gadobutrol injection
In the participants the technical adequacy (evaluability) of MR images was assessed on the following 4-point scale (1=not adequate [compromised quality], 2=partially adequate [evaluation possible], 3=adequate despite artifacts, 4=adequate with excellent quality).
Up to 1 hour after Gadobutrol injection
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
In the participants qualitative overall contrast quality of post contrast images was assessed on the following 6-point scale (none, poor, moderate, good, excellent, not assessable).
up to 1 hour after Gadobutrol injection
Pre-Contrast Lesions by Location and by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
Number of lesions on pre-contrast images by organ location and age group.
up to 1 hour after Gadobutrol injection
Post-Contrast Lesions by Location and by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
Number of lesions on post-contrast images by organ location and age group.
up to 1 hour after Gadobutrol injection
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
In the participants pre-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).
up to 1 hour after Gadobutrol injection
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
In the participants post-contrast delineation of each lesion/vessel border was assessed on the following 5-point scale (no, moderate, good, excellent, not assessable).
up to 1 hour after Gadobutrol injection
Pre-Contrast Lesion Characterization by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
In the participants the internal morphology and structure of each pre-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).
up to 1 hour after Gadobutrol injection
Post-Contrast Lesion Characterization by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
In the participants the internal morphology and structure of each post-contrast lesion was assessed on the following 4-point scale (1=poor, 2=moderate, 3=good, 4=not applicable).
up to 1 hour after Gadobutrol injection
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
Time Frame: up to 1 hour after Gadobutrol injection
In the participants the degree of contrast enhancement in each lesion/vessel was assessed on the following 5-point scale (1=no, 2=moderate, 3=good, 4=excellent, 5=not applicable).
up to 1 hour after Gadobutrol injection
Number of Participants With Change in Diagnostic Confidence by Age Group
Time Frame: up to 1 hour after Gadobutrol injection
In the participants the change in diagnostic confidence (additional diagnostic gain by the post-contrast scan) was assessed on the following 3-point scale (1=unchanged, 2=improved, 3=worsened).
up to 1 hour after Gadobutrol 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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 1, 2007

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.
April 1, 2008

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.
April 1, 2008

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).
May 2, 2007

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.
May 2, 2007

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.
May 3, 2007

Study Record Updates

Last Update Posted (Estimate)

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.
July 22, 2015

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.
June 29, 2015

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.
June 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

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.
  • 91552
  • 2006-004153-22 (EudraCT Number)
  • 310788 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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