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

Bayer

Status: Completed

Conditions: Liver Neoplasms; Liver Abscess; Carcinoma; Adenoma

Treatments: Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)

Study type: Observational

Funder types: Industry

Identifiers

NCT01043523

13729

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 2 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

52 participants in 1 patient group

Group 1

Treatment:

Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)