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NCT01043523 · ClinicalTrials.gov registry record
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 52
- Enrollment target
NCT01043523: Completed study, sponsored by Bayer.
NCT01043523 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01043523 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study Summary
Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.
Primary Outcome
Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesio
Interventions
- DRUG Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2009-12 |
| Est. Completion | 2013-04 |
What the finished NCT01043523 record still lists
NCT01043523 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Gadoxetic Acid Disodium (Eovist, BAY86-4873) is the first listed.
NCT01043523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01043523 about?
NCT01043523 is a clinical study titled "Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.". Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist...
What is the current status of trial NCT01043523?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2009-12. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01043523?
The interventions under investigation include: Gadoxetic Acid Disodium (Eovist, BAY86-4873) (DRUG).
Who is sponsoring clinical trial NCT01043523?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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