Magnetic Resonance ImagingNCT00905879
Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging
An observational study of Magnetic Resonance Imaging, run by Bayer at 1 site in Philippines.
Trial summary
Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- Gadobutrol (Gadovist, BAY86-4875)
- How many people
- 30 participants
- Where
- 1 sitePhilippines
- Study dates
- Jun 2009to Jan 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)
Who may be able to join
- 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)
Who cannot join
- History of hypersensitivity reaction to gadolinium containing contrast material
- Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
- History of hypersensitivity to any other contrast agent
- Patients with uncorrected hypokalemia
- Pregnant and lactating women
- Patients with severe cardiovascular diseases
- Patients in whom MRI cannot be performed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients
Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- Gadobutrol (Gadovist, BAY86-4875)
- Keywords
- Magnetic Resonance Imaging (MRI), Observational study, Gadobutrol
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 who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)
| 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.
The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events
Measured: Up to 1 hour after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJun 2009
- Study completionJan 2011
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905879
- Sponsor's protocol ID
- 13926
- Other IDs
- GV0811PH
- Status last verified
- Apr 2013
- First submitted
- 27 Apr 2009
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients
- ClinicalTrials.gov ID
- NCT00905879
- Acronym / sponsor ID
- 13926
- Conditions
- Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging (MRI), Observational study, Gadobutrol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Jan 2011 (actual)
- First posted
- 21 May 2009 (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.
Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.
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
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)
Key inclusion criteria (1 listed)
- 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)
Key exclusion criteria (7 listed)
- History of hypersensitivity reaction to gadolinium containing contrast material
- Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist)
- History of hypersensitivity to any other contrast agent
- Patients with uncorrected hypokalemia
- Pregnant and lactating women
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 who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist) | Drug | Group 1 |
Primary outcome
The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events
Time frame: Up to 1 hour after MRI
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 26 Apr 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging, run by Bayer at 1 site in Philippines.
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 7 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 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. 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?
The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events (time frame: Up to 1 hour after MRI). 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 26 Apr 2013.