General Safety Profile of DOTAREMNCT01523873
Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
An observational study of General Safety Profile of DOTAREM, run by Guerbet at 10 sites in 10 countries.
Trial summary
The main purpose of this study is to prospectively assess the general safety profile of Dotarem Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- General Safety Profile of DOTAREM
- How many people
- 35,921 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Nov 2008to Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All consecutive patients scheduled for a Dotarem®-enhanced MRI over a one year period at each participating radiological site
Who may be able to join
- patient scheduled for a Dotarem®-enhanced MRI
Who cannot join
- patient with a contra-indication to MR examination
- patient with a contra-indication to Dotarem® injection as per local SPC
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
The main purpose of this study is to prospectively assess the general safety profile of Dotarem
- Conditions
- General Safety Profile of DOTAREM
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Adverse Events were notified and described.
Measured: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).
Secondary outcomes (3)
Nephrogenic Systemic Fibrosis Incidence
For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.
Measured: Follow-up of at least 3 months after magnetic resonance examination
Image Quality
Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.
Measured: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)
Diagnostic Quality
Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no).
Measured: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startNov 2008
- Primary completionJul 2013
- Study completionJul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for General Safety Profile of 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
- 35,921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523873
- Sponsor's protocol ID
- DGD-55-001
- Status last verified
- Jan 2017
- First submitted
- 26 Jan 2012
- Last updated
- 24 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Heshmatzadeh Behzadi A, McDonald J. Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study. Medicine (Baltimore). 2022 Aug 26;101(34):e30163. doi: 10.1097/MD.0000000000030163.
PubMed 36042629
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)
- ClinicalTrials.gov ID
- NCT01523873
- Acronym / sponsor ID
- DGD-55-001
- Conditions
- General Safety Profile of DOTAREM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35,921 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 22 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to prospectively assess the general safety profile of Dotarem
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients scheduled for a Dotarem®-enhanced MRI over a one year period at each participating radiological site
Key inclusion criteria (1 listed)
- patient scheduled for a Dotarem®-enhanced MRI
Key exclusion criteria (2 listed)
- patient with a contra-indication to MR examination
- patient with a contra-indication to Dotarem® injection as per local SPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of Adverse Events
Time frame: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).
Adverse Events were notified and described.
3 secondary outcomes
Nephrogenic Systemic Fibrosis Incidence
Time frame: Follow-up of at least 3 months after magnetic resonance examination
Image Quality
Time frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)
Diagnostic Quality
Time frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36042629Heshmatzadeh Behzadi A, McDonald J. Gadolinium-based contrast agents for imaging of the central nervous system: A multicenter European prospective study. Medicine (Baltimore). 2022 Aug 26;101(34):e30163. doi: 10.1097/MD.0000000000030163.
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.
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Safety Profile of DOTAREM, run by Guerbet at 10 sites in 10 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 2 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Argentina, Austria, China, France, Germany and 5 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?
Yes. Results are posted in the registry (first posted 22 Jan 2016). 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: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).). 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 NCT01523873, 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 24 Feb 2017.