Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.

Completed

• Conditions: Liver Neoplasms; Adenoma; Carcinoma; Liver Abscess
• Interventions: Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)

• Registration Number: NCT01043523
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-02-24
• Results First Submitted QC: 2014-05-06
• Results First Posted: 2014-06-03
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Gadoxetic Acid Disodium (Eovist, BAY86-4873)	-

Primary Outcome Measures

Name	Time	Method
Vital Signs: Mean Change From Baseline in Systolic Blood Pressure	14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	Overall Change in additional diagnostic information was defined as a change in at least 1 of the 5 variables below obtained from the combined precontrast and postcontrast images as compared with the precontrast images: 1. Change in number of lesions: greater or fewer 2. Improved border delineation of the primary lesion 3. Increased contrast of primary lesion versus. background 4. Change in size of the primary lesion: larger or smaller 5. Change in information about lesion characterization (lesion type): improved, unchanged, worsened
Vital Signs: Mean Change From Baseline in Heart Rate	14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure	14 days prior to and up to 24 hours post-Eovist/Primovist MRI
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point	14 days prior to Eovist/Primovist MRI	Laboratory parameters analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes); Chemistry: lactate dehydrogenase (LDH), alkaline phosphatase (AKP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, bilirubin:, direct bilirubin, indirect bilirubin, total protein, albumin, estimated glomerular filtration rate (eGFR), and α-fetoprotein levels.
Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection	Up to 24 hours post-Eovist/Primovist MRI	The following parameters were analyzed: Hematology: leukocytes, erythrocytes, hematocrit, platelets, hemoglobin, prothrombin time and differential counts (neutrophils total, neutrophils segmented and lymphocytes) Clinical chemistry: lactate dehydrogenase (LDH), alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), sodium, potassium, blood urea nitrogen (BUN), glucose, creatinine, total bilirubin, direct bilirubin, indirect bilirubin, total protein, albumin, eGFR, and α-fetoprotein levels.

Secondary Outcome Measures

Name	Time	Method
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)	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI
Final Diagnosis (SoT) by Clinical Investigator	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 Only	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 Images	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 was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images
Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images	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 Images	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 was defined as a change from more to less or less to more obtained from the combined precontrast and postcontrast images as compared with the precontrast images
Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images	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 Images	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 Diagnosis.	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	Sensitivity is the probability that a test indicates there is disease when there is disease. Specificity is the probability that a test indicates there is no disease when there is no disease. Accuracy is the probability that a test is correct: the test indicates there is no disease when there is no disease and it indicates there is disease when there is disease.