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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


N/A
2 Months
18 Years
Open (Enrolling)
Both
Liver Neoplasms, Adenoma, Carcinoma, Liver Abscess

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

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.

Outcome Time Frame:

When precontrast and postcontrast images are available for all enrolled subjects

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

Singapore: Health Sciences Authority

Study ID:

13729

NCT ID:

NCT01043523

Start Date:

December 2009

Completion Date:

June 2013

Related Keywords:

  • Liver Neoplasms
  • Adenoma
  • Carcinoma
  • Liver Abscess
  • Liver neoplasms
  • Adenoma
  • Liver cell carcinoma
  • Hepatocellular
  • Liver abscess
  • Abscess
  • Adenoma
  • Neoplasms
  • Carcinoma
  • Liver Abscess
  • Liver Neoplasms

Name

Location

Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Charlotte, North Carolina