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

Completed

Conditions studied: Liver Neoplasms, Adenoma, Carcinoma, Liver Abscess

In brief

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.

Key facts

Study ID

NCT01043523

Run by

Bayer

People needed

52

Starts

2009-12-01

Expected to finish

2013-04-01

Last updated by the study team

2016-11-28

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >2 months and <18 years of age at the time of the Primovist/Eovist enhanced MRI
• MRI with Primovist/Eovist due to suspected or known focal liver lesions
• Evaluable safety data
• Evaluable efficacy data: precontrast and postcontrast magnetic resonance (MR) images must be available for review
• If the above criteria are met, the principal investigator (PI) and/or designee will obtain a signed consent for medical records release including access to anonymized electronic copies of the pre- and post-Primovist/Eovist MRI scans, in accordance with local regulatory requirements in order for subjects to be enrolled in the study.

You may not qualify if…

• A subject will be excluded from this observational / retrospective study if the subject has previously been enrolled into this study. Subjects may only be entered once into this study, even if they have been imaged multiple times and for different indications.

Where it is running

• Study site — Palo Alto, California, United States
• Study site — New York, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cinncinati, Ohio, United States
• Study site — Hershey, Pennsylvania, United States
• Study site — Many Locations, Italy
• Study site — Many Locations, Japan
• Study site — Many Locations, Singapore
• Study site — Many Locations, Taiwan

Full record on ClinicalTrials.gov

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