Magnetic Resonance ImagingNCT02540967
Drug Use Investigation of Gadovist.
An observational study of Magnetic Resonance Imaging and Image Enhancement, run by Bayer at 1 site in Japan.
Trial summary
The objectives of this study are to investigate the safety and effectiveness of Gadovist. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Magnetic Resonance Imaging, Image Enhancement
- What is being tested?
- Gadobutrol (Gadavist/Gadovist, BAY86-4875)
- How many people
- 3,357 participants
- Where
- 1 siteJapan
- Study dates
- 27 Oct 2015to 2 Nov 2017
- 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: Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF
Who may be able to join
- Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.
Who cannot join
- Patients who are contraindicated based on approved label.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Investigation of Gadovist
The objectives of this study are to investigate the safety and effectiveness of Gadovist.
Read the detailed description
This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).
The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.
For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).
- Conditions
- Magnetic Resonance Imaging, Image Enhancement
- Being tested
- Gadobutrol (Gadavist/Gadovist, BAY86-4875)
- Keywords
- Contrast enhancement in the following MR imaging, Brain and spine, Body and extremities, Gadobutrol
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
Gadovist dosage following summary of product characteristics
| Study group | Role | What they receive |
|---|---|---|
| BAY86-4875 | Gadovist administration goup Receives: Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of adverse events as a measure of safety and tolerability
Measured: Up to 3 days
Secondary outcomes (2)
Number of episodes of adverse drug reactions and adverse events
In subpopulations
Measured: Up to 3 days
Contrast enhancement
Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.
MRI- Magnetic Resonance Imaging
Measured: At the time of MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study start27 Oct 2015
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,357 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
- NCT02540967
- Sponsor's protocol ID
- 17512
- Status last verified
- Nov 2023
- First submitted
- 2 Sep 2015
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 Sep 19.
PubMed 30232584
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Gadovist
- ClinicalTrials.gov ID
- NCT02540967
- Acronym / sponsor ID
- 17512
- Conditions
- Magnetic Resonance Imaging, Image Enhancement
- Keywords
- Contrast enhancement in the following MR imaging, Brain and spine, Body and extremities, Gadobutrol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,357 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 4 Sep 2015 (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.
The objectives of this study are to investigate the safety and effectiveness of Gadovist.
Detailed description
This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).
The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.
For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY86-4875 | – | Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)Gadovist administration goup |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF
Key inclusion criteria (1 listed)
- Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.
Key exclusion criteria (1 listed)
- Patients who are contraindicated based on approved label.
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)Gadovist dosage following summary of product characteristics | Drug | BAY86-4875 |
Primary outcome
Number of episodes of adverse events as a measure of safety and tolerability
Time frame: Up to 3 days
2 secondary outcomes
Number of episodes of adverse drug reactions and adverse events
Time frame: Up to 3 days
Contrast enhancement
Time frame: At the time of 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 7 Nov 2023.
- Results publication: PubMed 30232584Tsushima Y, Awai K, Shinoda G, Miyoshi H, Chosa M, Sunaya T, Endrikat J. Post-marketing surveillance of gadobutrol for contrast-enhanced magnetic resonance imaging in Japan. Jpn J Radiol. 2018 Nov;36(11):676-685. doi: 10.1007/s11604-018-0778-4. Epub 2018 Sep 19.
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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 and Image Enhancement, run by Bayer at 1 site in Japan.
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 7 Nov 2023. 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 Japan. 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 episodes of adverse events as a measure of safety and tolerability (time frame: Up to 3 days). 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 NCT02540967, which also lists 1 linked publication.
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 7 Nov 2023.