Magnetic Resonance ImagingPhase 1NCT00468819
A Study of Magnetic Resonance Imaging (MRI) With Gadavist in Children
A Phase 1 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) in people with Magnetic Resonance Imaging, run by Bayer at 14 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 14 sitesin 4 countries
- Study dates
- May 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Germany8 sites
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Dresden, Saxony, 01307
Study site
Erlangen, Bavaria, 91054
Study site
Halle, Saxony-Anhalt, 06120
Study site
Jena, Thuringia, 07740
Study site
Kiel, Schleswig-Holstein, 24103
Study site
Kiel, Schleswig-Holstein, 24105
Study site
Leipzig, Saxony, 04103
Sweden3 sites
Study site
Gothenburg, 41485
Study site
Stockholm, 17176
Study site
Uppsala, 75185
Canada2 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Toronto, Ontario, M5G 1X8
About this study
Official title: 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.
Read the detailed description
Please note that the present study is allocated two study phases, i.e. phase I and phase III.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- Keywords
- Contrast-enhanced MRI, MR angiography (MRA) Children 2-17 years
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)Drug
In an open-label design, all patients will receive a total dose of 0.1 mmol/kg BW Gadovist 1.01 Days Injection
| Study group | Role | What they receive |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - age 2 to 6 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
| Gadobutrol (Gadavist, BAY86-4875) - age 7 to 11 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
| Gadobutrol (Gadavist, BAY86-4875) - age 12 to 17 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
| Gadobutrol (Gadavist, BAY86-4875) - age 2 to 17 years | Experimental | Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Clearance Estimates of Gadobutrol by Age Group
Total body clearance of Gadobutrol in plasma in L/h after intravenous injection.
Measured: From injection of Gadobutrol up to 8 hours after injection.
Body Weight-corrected Plasma Clearance Estimates of Gadobutrol by Age Group
Total body clearance of Gadobutrol in plasma corrected for body weight (L/h/kg) after intravenous injection.
Measured: From injection up to 8 hours after Gadobutrol injection
Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
Apparent volume of distribution at steady state expressed in L after intravenous injection.
Measured: From injection up to 8 hours after Gadobutrol injection
Body Weight-corrected Volume Distribution at Steady State (Vss) Estimates of Gadobutrol by Age Group
Apparent volume of distribution at steady state corrected for body weight (L/h/kg) after intravenous injection.
Measured: From injection to 8 hours after Gadobutrol injection
Area Under the Drug Concentration-time Curve of Gadobutrol by Age Group
Area under the concentration versus time curve from zero to infinity after intravenous injection expressed in µmol*h/L.
Measured: From injection to 8 hours after Gadobutrol injection
Terminal Elimination Half Life Estimates of Gadobutrol by Age Group
Terminal elimination half-life of Gadobutrol from plasma expressed in h and derived from the terminal slope of the concentration versus time curve.
Measured: From injection to 8 hours after Gadobutrol injection
Mean Residence Time (MRT) Estimates of Gadobutrol by Age Group
Mean residence time of Gadobutrol in plasma expressed in h.
Measured: From injection to 8 hours after Gadobutrol injection
Secondary outcomes (11)
Urinary Excretion of Gadolinium as Percent of Administered Dose
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.
Measured: up to 6 hours after Gadobutrol injection
Number of Participants With Basic Technical Adequacy of Magnetic Resonance (MR) Images for Diagnosis by Age Group
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).
Measured: Up to 1 hour after Gadobutrol injection
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
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).
Measured: up to 1 hour after Gadobutrol injection
Pre-Contrast Lesions by Location and by Age Group
Number of lesions on pre-contrast images by organ location and age group.
Measured: up to 1 hour after Gadobutrol injection
Post-Contrast Lesions by Location and by Age Group
Number of lesions on post-contrast images by organ location and age group.
Measured: up to 1 hour after Gadobutrol injection
Pre-Contrast Delineation of Lesion/Vessel Border by Age Group
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).
Measured: up to 1 hour after Gadobutrol injection
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
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).
Measured: up to 1 hour after Gadobutrol injection
Pre-Contrast Lesion Characterization by Age Group
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).
Measured: up to 1 hour after Gadobutrol injection
Post-Contrast Lesion Characterization by Age Group
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).
Measured: up to 1 hour after Gadobutrol injection
Degree of Contrast Enhancement in Lesion/Vessel by Age Group (Given Are Total Numbers of Lesions)
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).
Measured: up to 1 hour after Gadobutrol injection
Number of Participants With Change in Diagnostic Confidence by Age Group
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).
Measured: up to 1 hour after Gadobutrol injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468819
- Sponsor's protocol ID
- 91552
- Other IDs
- 2006-004153-22, 310788
- Status last verified
- Jun 2015
- First submitted
- 2 May 2007
- Last updated
- 22 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hahn G, Sorge I, Gruhn B, Glutig K, Hirsch W, Bhargava R, Furtner J, Born M, Schroder C, Ahlstrom H, Kaiser S, Moritz JD, Kunze CW, Shroff M, Stokland E, Trnkova ZJ, Schultze-Mosgau M, Reif S, Bacher-Stier C, Mentzel HJ. Pharmacokinetics and safety of gadobutrol-enhanced magnetic resonance imaging in pediatric patients. Invest Radiol. 2009 Dec;44(12):776-83. doi: 10.1097/RLI.0b013e3181bfe2d2.
PubMed 19858730Reif S, Schultze-Mosgau M, Sutter G. From adults to children: simulation-based choice of an appropriate sparse-sampling schedule. Paediatr Drugs. 2012 Jun 1;14(3):189-200. doi: 10.2165/11595430-000000000-00000.
PubMed 22409261
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00468819
- Acronym / sponsor ID
- 91552
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Contrast-enhanced MRI, MR angiography (MRA) Children 2-17 years
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 May 2007 (estimated)
- Results
- Posted 5 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please note that the present study is allocated two study phases, i.e. phase I and phase III.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) - age 2 to 6 years | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| Gadobutrol (Gadavist, BAY86-4875) - age 7 to 11 years | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| Gadobutrol (Gadavist, BAY86-4875) - age 12 to 17 years | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
| Gadobutrol (Gadavist, BAY86-4875) - age 2 to 17 years | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875)Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Gadobutrol (Gadavist, BAY86-4875) - age 12 to 17 years, Gadobutrol (Gadavist, BAY86-4875) - age 2 to 17 years, Gadobutrol (Gadavist, BAY86-4875) - age 2 to 6 years, Gadobutrol (Gadavist, BAY86-4875) - age 7 to 11 years |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
11 secondary outcomes
Urinary Excretion of Gadolinium as Percent of Administered Dose
Time frame: 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
Number of Participants With Overall Contrast Quality of Post Contrast Images by Age Group
Time frame: 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
Post-Contrast Lesions by Location and by Age Group
Time frame: 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
Post-Contrast Delineation of Lesion/Vessel Border by Age Group
Time frame: up to 1 hour after Gadobutrol injection
Pre-Contrast Lesion Characterization by Age Group
Time frame: up to 1 hour after Gadobutrol injection
Post-Contrast Lesion Characterization by Age Group
Time frame: 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
Number of Participants With Change in Diagnostic Confidence by Age Group
Time frame: up to 1 hour after Gadobutrol injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19858730Hahn G, Sorge I, Gruhn B, Glutig K, Hirsch W, Bhargava R, Furtner J, Born M, Schroder C, Ahlstrom H, Kaiser S, Moritz JD, Kunze CW, Shroff M, Stokland E, Trnkova ZJ, Schultze-Mosgau M, Reif S, Bacher-Stier C, Mentzel HJ. Pharmacokinetics and safety of gadobutrol-enhanced magnetic resonance imaging in pediatric patients. Invest Radiol. 2009 Dec;44(12):776-83. doi: 10.1097/RLI.0b013e3181bfe2d2.
- Results publication: PubMed 22409261Reif S, Schultze-Mosgau M, Sutter G. From adults to children: simulation-based choice of an appropriate sparse-sampling schedule. Paediatr Drugs. 2012 Jun 1;14(3):189-200. doi: 10.2165/11595430-000000000-00000.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
Related trials for Magnetic Resonance Imaging
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Not yet recruiting
Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study.
Stroke
Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
Recruiting
Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
Dystonia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) in people with Magnetic Resonance Imaging, run by Bayer at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany, Sweden, Canada, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Clearance Estimates of Gadobutrol by Age Group (time frame: From injection of Gadobutrol up to 8 hours after injection.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00468819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.