Trial Condition(s):

Liver neoplasms, Adenoma, Carcinoma, Liver abscess

Liver MRI with Primovist/Eovist in pediatric subjects who are suspected or have focal liver lesions.

Bayer Identifier:

13729

ClinicalTrials.gov Identifier:

NCT01043523

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
52
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Durham, United States, 27710

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Singapore

Status
Terminated
 
Locations

Investigative Site

New York, United States, 10032

Status
Completed
 
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 
Locations

Investigative Site

Many Locations, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Hershey, United States, 17033

Status
Terminated
 
Locations

Investigative Site

Cinncinati, United States, 45229

Status
Completed
 
Locations

Investigative Site

Palo Alto, United States, 94304

Status
Terminated
 

Trial Design