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Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions. | Clinical Trials | Clareo Health

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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

NCT01043523•Bayer

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 18 years

Sex

ALL

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.

Locations (9)

Palo Alto, California, United States

New York, New York, United States

Durham, North Carolina, United States

Cinncinati, Ohio, United States

Hershey, Pennsylvania, United States

Many Locations, Italy

Many Locations, Japan

Many Locations, Singapore

Many Locations, Taiwan

Key Dates

Start Date

December 1, 2009

Primary Completion Date

April 1, 2013

Completion Date

April 1, 2013

Last Updated

November 28, 2016

Enrollment

ACTUAL participants

Conditions

Liver NeoplasmsAdenomaCarcinomaLiver Abscess

Interventions

Gadoxetic Acid Disodium (Eovist, BAY86-4873)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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