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
  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.


Condition Intervention
Liver Neoplasms
Adenoma
Carcinoma
Liver Abscess
Drug: Gadoxetic Acid Disodium (Primovist/Eovist, BAY86-4873)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

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


Enrollment: 52
Study Start Date: December 2009
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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

  Eligibility

Ages Eligible for Study:   2 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043523

Locations
United States, California
Palo Alto, California, United States, 94304
United States, New York
New York, New York, United States, 10032
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cinncinati, Ohio, United States, 45229
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Italy
Many Locations, Italy
Japan
Many Locations, Japan
Singapore
Many Locations, Singapore
Taiwan
Many Locations, Taiwan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT01043523     History of Changes
Other Study ID Numbers: 13729
Study First Received: January 4, 2010
Last Updated: July 31, 2013
Health Authority: Singapore: Health Sciences Authority
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Bayer:
Liver neoplasms
Adenoma
Liver cell carcinoma
Hepatocellular
Liver abscess

Additional relevant MeSH terms:
Abscess
Adenoma
Neoplasms
Carcinoma
Liver Abscess
Liver Neoplasms
Suppuration
Infection
Inflammation
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Abscess
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on April 23, 2014