Contrast-enhanced MRI With Dotarem
Conditions
Brief 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 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.
Interventions
PROCEDUREMRI with Dotarem
Sponsors
Guerbet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing routine MRI using the MRI contrast medium Dotarem
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Value | During MRI procedure | 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 ? |
| Image Quality | During MRI procedure | Image quality was evaluated with a 5-step scale from excellent to very poor (excellent/very good; good; moderate; poor and very poor) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Included Patients All included patients underwent MRI with Dotarem | 44,456 |
| Total | 44,456 |
Baseline characteristics
| Characteristic | All Included Patients |
|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 16.9 |
| Age, Customized ≥18 years | 43590 Participants |
| Age, Customized <2 years | 1 Participants |
| Age, Customized between 12 and 17 years | 617 Participants |
| Age, Customized between 2 and 11 years | 81 Participants |
| Risk factors Beta-blocker treatment | 648 Participants |
| Risk factors Bronchial asthma | 630 Participants |
| Risk factors Central nervous system disorders | 560 Participants |
| Risk factors Coronary heart disease | 824 Participants |
| Risk factors Heart failure | 413 Participants |
| Risk factors History of a reaction to a contrast agent | 176 Participants |
| Risk factors Hypertension | 2479 Participants |
| Risk factors Known allergies | 6871 Participants |
| Risk factors Liver dysfunction | 121 Participants |
| Risk factors Other | 858 Participants |
| Sex: Female, Male Female | 24254 Participants |
| Sex: Female, Male Male | 19515 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 44,456 |
| other Total, other adverse events | 132 / 44,456 |
| serious Total, serious adverse events | 7 / 44,456 |
Outcome results
Primary
Frequency of Adverse Events
The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.
Time frame: From the beginning of the MRI procedure to 30-60 min after
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Included Patients | Frequency of Adverse Events | 225 adverse events |
Secondary
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 ?
Time frame: During MRI procedure
Population: Diagnostic value was missing for 77 patients.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Included Patients | Diagnostic Value | Diagnosis achieved | 44312 Participants |
| All Included Patients | Diagnostic Value | Diagnosis not achieved | 67 Participants |
Secondary
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)
Time frame: During MRI procedure
Population: Image quality was missing for 108 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Included Patients | Image Quality | Very Poor | 2 Participants |
| All Included Patients | Image Quality | Excellent | 25580 Participants |
| All Included Patients | Image Quality | Good | 18218 Participants |
| All Included Patients | Image Quality | Moderate | 516 Participants |
| All Included Patients | Image Quality | Poor | 32 Participants |