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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01043523
First received: January 4, 2010
Last updated: July 31, 2013
Last verified: July 2013

January 4, 2010
July 31, 2013
December 2009
April 2013   (final data collection date for primary outcome measure)
  • Additional diagnostic information obtained from the combined precontrast and postcontrast images as compared with the precontrast images. To be determined by an independent blinded read. [ Time Frame: When precontrast and postcontrast images are available for all enrolled subjects ] [ Designated as safety issue: No ]
  • Additional safety information [ Time Frame: 24 hours pre Eovist/Primovist administration to 1 year post Eovist/Primovist administration ] [ Designated as safety issue: Yes ]
  • Additional diagnostic information obtained from the combined precontrast and postcontrast images as compared with the precontrast images. To be determined by an independent blinded read [ Time Frame: When precontrast and postcontrast images are available for all enrolled subjects ] [ Designated as safety issue: No ]
  • Additional safety information [ Time Frame: 24 hours prePrimovist/Eovist administration to 1 year post Primovist/Eovist administration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01043523 on ClinicalTrials.gov Archive Site
  • For the pre-vs.combined pre-and postcontrast images,comparison of any change in the diagnosis, diagnostic confidence and management/therapy; any malignant or nonmalignant lesions detected on the combined pre-and post-images not detected on the pre-images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
  • For the postcontrast images only, the overall image quality [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
  • Serious Adverse Events collection [ Time Frame: End of Study (on average 1 year post Primovist/Eovist MRI) ] [ Designated as safety issue: Yes ]
  • For the pre-vs.combined pre-and postcontrast images,comparison of any change in the diagnosis, diagnostic confidence and management/therapy; any malignant or nonmalignant lesions detected on the combined pre-and post-images not detected on the pre-images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
  • For the postcontrast images only, the overall image quality [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
  • Serious Adverse Events collection [ Time Frame: End of Study (on average 1 year post Primovist/Eovist MRI) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

Pediatric subjects who have had a Eovist/Primovist enhanced MRI for known or suspected focal liver disease

Non-Probability Sample

Pediatric subjects who have had a Primovist/Eovist enhanced MRI for known or suspected focal liver disease

  • Liver Neoplasms
  • Adenoma
  • Carcinoma
  • Liver Abscess
Drug: Gadoxetic Acid Disodium (Primovist/Eovist, BAY86-4873)
Subjects will have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and will be identified retrospectively from institution records
Group 1
Intervention: Drug: Gadoxetic Acid Disodium (Primovist/Eovist, BAY86-4873)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
July 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
2 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Japan,   Singapore,   Taiwan
 
NCT01043523
13729
No
Global Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP