Trial Condition(s):
Liver neoplasms, Adenoma, Carcinoma, Liver abscess
Liver MRI with Primovist/Eovist in pediatric subjects who are suspected or have focal liver lesions.
Bayer Identifier:
13729
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Durham, United States, 27710 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Singapore | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 10032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cinncinati, United States, 45229 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palo Alto, United States, 94304 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Percentage of participants with overall change in additional diagnostic information obtained when comparing the combined precontrast/postcontrast images with the precontrast images.Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Number of participants with laboratory values considered to be clinically relevant values or abnormalities at pre-injection time pointTimeframe: 14 days prior to Eovist/Primovist MRI
- Number of participants with laboratory values considered to be clinically relevant values or abnormalities 24 hours post-injectionTimeframe: Up to 24 hours post-Eovist/Primovist MRI
- Vital Signs: Mean change from baseline in heart rateTimeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
- Vital Signs: Mean change from baseline in systolic blood pressureTimeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
- Vital Signs: Mean change from baseline in diastolic blood pressureTimeframe: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Secondary Outcome
- Change in diagnosis obtained from the combined precontrast and postcontrast images as compared with the precontrast imagesTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Change in confidence of diagnosis obtained from the combined precontrast and postcontrast images as compared with the precontrast imagesTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Change in number of nonmalignant lesions obtained from the combined precontrast and postcontrast images as compared with the precontrast imagesTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Change in number of malignant lesions obtained from the combined precontrast and postcontrast images as compared with the precontrast imagesTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Change in recommended next course of subject management/therapy obtained from the combined precontrast and postcontrast images as compared with the precontrast imagesTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- 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)Timeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- The overall image quality for the postcontrast image onlyTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Final diagnosis (SoT) by Clinical investigatorTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
- Sensitivity, specificity and accuracy of blinded read of precontrast and combined precontrast/postcontrast images based on Final diagnosisTimeframe: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Additional Information
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