Magnetic Resonance ImagingGARDIANNCT01095081
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
An observational study of Magnetic Resonance Imaging and Magnetic Resonance Angiography, run by Bayer at 20 sites in 20 countries.
Trial summary
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Magnetic Resonance Imaging, Magnetic Resonance Angiography
- What is being tested?
- Gadobutrol (Gadovist, BAY86-4875)
- How many people
- 23,775 participants
- Where
- 20 sitesin 20 countries
- Study dates
- Jul 2010to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
Who may be able to join
- Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
Who cannot join
- There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.
Trial locations and contacts
20 sites in 20 countries.
20 sites in 20 countries
About this study
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients
Read the detailed description
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
- Being tested
- Gadobutrol (Gadovist, BAY86-4875)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadovist, BAY86-4875)Drug
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Gadobutrol (Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups
Measured: 1 day
Secondary outcomes (1)
Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,775 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
- NCT01095081
- Sponsor's protocol ID
- 14823
- Other IDs
- GV0901
- Acronym
- GARDIAN
- Status last verified
- Jan 2015
- First submitted
- 17 Mar 2010
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
- ClinicalTrials.gov ID
- NCT01095081
- Acronym / sponsor ID
- GARDIAN / 14823
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,775 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients
Detailed description
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Gadobutrol (Gadovist, BAY86-4875) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
Key inclusion criteria (1 listed)
- Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
Key exclusion criteria (1 listed)
- There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.
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 (Gadovist, BAY86-4875)Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician. | Drug | Group 1 |
Primary outcome
Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups
Time frame: 1 day
1 secondary outcome
Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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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
20 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging and Magnetic Resonance Angiography, run by Bayer at 20 sites in 20 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 1 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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Bosnia and Herzegovina, Canada, China, Czechia, France and 15 more countries. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2015.