NCT01043523

Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 2 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Neoplasms
• Adenoma
• Carcinoma
• Liver Abscess

Interventions

Type	Name	Description
DRUG	Gadoxetic Acid Disodium (Eovist, BAY86-4873)	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

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-01-06
• Last updated: 2016-11-28
• Results posted: 2014-06-03

Locations

9 sites across 5 countries: United States, Italy, Japan, Singapore, Taiwan