Image Enhancement, Magnetic Resonance Imaging
Conditions
Keywords
Contrast enhancement in the following MR imaging, Brain and spine, Body and extremities, Gadobutrol
Brief summary
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).
Interventions
Gadovist dosage following summary of product characteristics
Sponsors
Bayer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.
Exclusion criteria
* Patients who are contraindicated based on approved label.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of episodes of adverse events as a measure of safety and tolerability | Up to 3 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of episodes of adverse drug reactions and adverse events | Up to 3 days | In subpopulations |
| Contrast enhancement | At the time of MRI | Investigator Discretion as very improved , improved, not changed, degraded, not evaluable. MRI- Magnetic Resonance Imaging |
Countries
Japan
Outcome results
None listed