Contrast-enhanced MRI With DotaremNCT03048006
Post-marketing Surveillance Study for Evaluation of Dotarem Safety
An observational study of Contrast-enhanced MRI With Dotarem, run by Guerbet.
Trial summary
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to… Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast-enhanced MRI With Dotarem
- What is being tested?
- MRI with Dotarem
- Type of treatment
- Surgery or procedure
- How many people
- 44,456 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- 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 Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adult and pediatric patients undergoing routine MRI using the MRI contrast medium Dotarem
Who may be able to join
- Patients undergoing routine MRI using the MRI contrast medium Dotarem
Who cannot join
- -
About this study
Official title: Evaluation of Dotarem Safety
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.
Read the detailed description
Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.
- Conditions
- Contrast-enhanced MRI With Dotarem
- Being tested
- MRI with Dotarem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI with DotaremProcedure or surgery
Also called MRI with gadoteric acid/gadoterate meglumine
| Study group | Role | What they receive |
|---|---|---|
| All included patients | All included patients underwent MRI with Dotarem Receives: Procedure: MRI with Dotarem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Measured: From the beginning of the MRI procedure to 30-60 min after
Secondary outcomes (2)
Diagnostic Value
Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"
Measured: During MRI procedure
Image Quality
Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")
Measured: During MRI procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
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.
- Other trials for Contrast-enhanced MRI With DotaremStudies of the same condition, open and under way.
- 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
- 44,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048006
- Sponsor's protocol ID
- DGD-55-005
- Status last verified
- Mar 2017
- First submitted
- 1 Feb 2017
- Last updated
- 2 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dotarem Safety
- ClinicalTrials.gov ID
- NCT03048006
- Acronym / sponsor ID
- DGD-55-005
- Conditions
- Contrast-enhanced MRI With Dotarem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44,456 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 2 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.
Detailed description
Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All included patients | – | Procedure: MRI with DotaremAll included patients underwent MRI with Dotarem |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric patients undergoing routine MRI using the MRI contrast medium Dotarem
Key inclusion criteria (1 listed)
- Patients undergoing routine MRI using the MRI contrast medium Dotarem
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| MRI with DotaremAlso: MRI with gadoteric acid/gadoterate meglumine | Procedure or surgery | All included patients |
Primary outcome
Frequency of Adverse Events
Time frame: From the beginning of the MRI procedure to 30-60 min after
The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
2 secondary outcomes
Diagnostic Value
Time frame: During MRI procedure
Image Quality
Time frame: During MRI procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast-enhanced MRI With Dotarem, run by Guerbet.
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 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 2 May 2017). 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?
Frequency of Adverse Events (time frame: From the beginning of the MRI procedure to 30-60 min after). 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 2 May 2017.