N/A
N=52
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.
Liver Neoplasms · Adenoma · Carcinoma · Liver Abscess
Bottom Line
View on ClinicalTrials.gov: NCT01043523 ↗Enrolled (actual)
52
Serious AEs
40.4%
Results posted
Jun 2014
Primary outcome: Primary: Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images. — 86.3 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gadoxetic Acid Disodium (Eovist, BAY86-4873) (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images. |
86.3 | — |
| PRIMARY Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point |
1; 1; 1 | — |
| PRIMARY Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection |
— | — |
| PRIMARY Vital Signs: Mean Change From Baseline in Heart Rate |
-4.17 | — |
| PRIMARY Vital Signs: Mean Change From Baseline in Systolic Blood Pressure |
-1.76 | — |
| PRIMARY Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure |
-0.46 | — |
| SECONDARY Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images |
25; 26 | — |
| SECONDARY Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images |
10; 41 | — |
| SECONDARY Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images |
18; 33 | — |
| SECONDARY Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images |
11; 40 | — |
| SECONDARY Change in Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images |
45; 6 | — |
| SECONDARY 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) |
7; 1; 0; 26; 1; 13 | — |
| SECONDARY The Overall Image Quality for the Postcontrast Image Only |
34; 8; 9 | — |
| SECONDARY Final Diagnosis (SoT) by Clinical Investigator |
27; 24 | — |
| SECONDARY Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. |
66.7; 70.8; 88.9; 66.7; 78.4; 68.6 | — |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01043523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.