check_circleStudy Completed

Liver neoplasms, Adenoma, Carcinoma, Liver abscess

Bayer Identifier:

13729

ClinicalTrials.gov Identifier:

NCT01043523

EudraCT Number:

Not Available

EU CT Number:

Not Available
Liver MRI with Primovist/Eovist in pediatric subjects who are suspected or have focal liver lesions.

Trial 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.

Key Participants Requirements

Sex

Both

Age

2 - 18 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
52
Trial Dates
December 2009 - April 2013
Phase
N/A
Could I Receive a placebo
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Durham, 27710, United States
Completed
Many Locations, Italy
Terminated
Many Locations, Singapore
Completed
New York, 10032, United States
Completed
Many Locations, Japan
Completed
Many Locations, Taiwan
Terminated
Hershey, 17033, United States
Completed
Cinncinati, 45229, United States
Terminated
Palo Alto, 94304, United States

Primary Outcome

  • Percentage of participants with overall change in additional diagnostic information obtained when comparing the combined precontrast/postcontrast images with the precontrast images.
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with laboratory values considered to be clinically relevant values or abnormalities at pre-injection time point
    date_rangeTime Frame:
    14 days prior to Eovist/Primovist MRI
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with laboratory values considered to be clinically relevant values or abnormalities 24 hours post-injection
    date_rangeTime Frame:
    Up to 24 hours post-Eovist/Primovist MRI
    enhanced_encryption
    Safety Issue:
    Yes
  • Vital Signs: Mean change from baseline in heart rate
    date_rangeTime Frame:
    14 days prior to and up to 24 hours post-Eovist/Primovist MRI
    enhanced_encryption
    Safety Issue:
    Yes
  • Vital Signs: Mean change from baseline in systolic blood pressure
    date_rangeTime Frame:
    14 days prior to and up to 24 hours post-Eovist/Primovist MRI
    enhanced_encryption
    Safety Issue:
    Yes
  • Vital Signs: Mean change from baseline in diastolic blood pressure
    date_rangeTime Frame:
    14 days prior to and up to 24 hours post-Eovist/Primovist MRI
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change in diagnosis obtained from the combined precontrast and postcontrast images as compared with the precontrast images
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Change in confidence of diagnosis obtained from the combined precontrast and postcontrast images as compared with the precontrast images
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Change in number of nonmalignant lesions obtained from the combined precontrast and postcontrast images as compared with the precontrast images
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Change in number of malignant lesions obtained from the combined precontrast and postcontrast images as compared with the precontrast images
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Change in recommended next course of subject management/therapy obtained from the combined precontrast and postcontrast images as compared with the precontrast images
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Change in recommended next course of subject management / therapy – comparison of precontrast versus combined precontrast/postcontrast images (only subjects for whom a change was documented)
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • The overall image quality for the postcontrast image only
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Final diagnosis (SoT) by Clinical investigator
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No
  • Sensitivity, specificity and accuracy of blinded read of precontrast and combined precontrast/postcontrast images based on Final diagnosis
    date_rangeTime Frame:
    When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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