CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 52 enrolled
Drug / intervention
Gadoxetic Acid Disodium (Eovist, BAY86-4873)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01043523
NCT01043523N/ACompleted

An Observational Study of the Administration of Eovist/Primovist in Pediatric Subjects (> 2 Months and Less Than 18 Years) Who Are Referred for a Routine Contrast Enhanced Liver MRI Because of Suspected or Known Focal Liver Lesions

Bayer·observational·Posted Jan 6, 2010·Updated Nov 28, 2016

In Brief

An observational study evaluating Gadoxetic Acid Disodium (Eovist, BAY86-4873) for Liver Neoplasms and 3 related conditions. Completed, enrolled 52 participants across 9 sites in 5 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly, Japan, Singapore, Taiwan, United States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2010
Enrollment StartDec 1, 2009
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 16.5 years ago

Interventions

Gadoxetic Acid Disodium (Eovist, BAY86-4873)drug

Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records