Trials / Completed
CompletedNCT03455283
Post-marketing Safety Study in Participants of All Pathologies Who Receive Gadolinium-Based Contrast Agents (GBCAs) for Contrast-Enhanced Magnetic Resonance Imaging (MR) Examination
A Study of Pattern of Use for Gadolinium-Based Contrast Agents (GBCAs) in Patients Undergoing Contrast-Enhanced Magnetic Resonance (CE-MR) Examination - A Prospective, Multicenter, Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,118 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to prospectively collect data on the pattern of use for gadolinium-based contrast agents (GBCAs) in real-life setting with special reference to Clariscan after its commercial launch in Europe and in addition quality of images, diagnostic confidence and customer satisfaction will be assessed on a Likert scale by the local radiologist/technician and spontaneously reported immediate and delayed adverse events (AEs) to assess the effectiveness and safety profile of GBCAs in clinical practice respectively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clariscan | Clariscan 0.5 mmol/ml solution for injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need. |
| OTHER | Gadolinium-Based Contrast Agents | All GBCAs will be selected by the sites and recorded as by the brand names. |
Timeline
- Start date
- 2018-12-17
- Primary completion
- 2019-11-11
- Completion
- 2019-11-11
- First posted
- 2018-03-06
- Last updated
- 2019-12-04
Locations
2 sites across 2 countries: Germany, Norway
Source: ClinicalTrials.gov record NCT03455283. Inclusion in this directory is not an endorsement.