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

NCT ID: NCT01043523

Last Updated: 2016-11-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Neoplasms Adenoma Carcinoma Liver Abscess

Keywords

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Liver neoplasms Adenoma Liver cell carcinoma Hepatocellular Liver abscess

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Gadoxetic Acid Disodium (Eovist, BAY86-4873)

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Palo Alto, California, United States

Site Status

New York, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Cinncinati, Ohio, United States

Site Status

Hershey, Pennsylvania, United States

Site Status

Many Locations, , Italy

Site Status

Many Locations, , Japan

Site Status

Many Locations, , Singapore

Site Status

Many Locations, , Taiwan

Site Status

Countries

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United States Italy Japan Singapore Taiwan

References

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Geller J, Kasahara M, Martinez M, Soresina A, Kashanian F, Endrikat J. Safety and Efficacy of Gadoxetate Disodium-Enhanced Liver MRI in Pediatric Patients Aged >2 Months to <18 Years-Results of a Retrospective, Multicenter Study. Magn Reson Insights. 2016 Jul 21;9:21-8. doi: 10.4137/MRI.S39091. eCollection 2016.

Reference Type RESULT
PMID: 27478381 (View on PubMed)

Other Identifiers

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13729

Identifier Type: -

Identifier Source: org_study_id