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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01043523
First received: January 4, 2010
Last updated: May 6, 2014
Last verified: May 2014

January 4, 2010
May 6, 2014
December 2009
April 2013   (final data collection date for primary outcome measure)
  • Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images. [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
    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
  • Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point [ Time Frame: 14 days prior to Eovist/Primovist MRI ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Up to 24 hours post-Eovist/Primovist MRI ] [ Designated as safety issue: Yes ]
    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.
  • Vital Signs: Mean Change From Baseline in Heart Rate [ Time Frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI ] [ Designated as safety issue: Yes ]
  • Vital Signs: Mean Change From Baseline in Systolic Blood Pressure [ Time Frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI ] [ Designated as safety issue: Yes ]
  • Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure [ Time Frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: When precontrast and postcontrast images are available for all enrolled subjects ] [ Designated as safety issue: No ]
  • Additional safety information [ Time Frame: 24 hours prePrimovist/Eovist administration to 1 year post Primovist/Eovist administration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01043523 on ClinicalTrials.gov Archive Site
  • Change in Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Change in Confidence of Diagnosis Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
    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 Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
    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 Recommended Next Course of Subject Management/Therapy Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as 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) [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • The Overall Image Quality for the Postcontrast Image Only [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Final Diagnosis (SoT) by Clinical Investigator [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis. [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
    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.
  • For the pre-vs.combined pre-and postcontrast images,comparison of any change in the diagnosis, diagnostic confidence and management/therapy; any malignant or nonmalignant lesions detected on the combined pre-and post-images not detected on the pre-images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
  • For the postcontrast images only, the overall image quality [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
  • Serious Adverse Events collection [ Time Frame: End of Study (on average 1 year post Primovist/Eovist MRI) ] [ Designated as safety issue: Yes ]
  • Change in Number of Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Improved Border Delineation of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Increased Contrast of Primary Lesion vs Background Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Change in Size of the Primary Lesion Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
  • Change in Information About Lesion Characterization Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ] [ Designated as safety issue: No ]
Not Provided
 
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   None Retained
Description:

Pediatric subjects who have had a Eovist/Primovist enhanced MRI for known or suspected focal liver disease

Non-Probability Sample

Pediatric subjects who have had a Primovist/Eovist enhanced MRI for known or suspected focal liver disease

  • Liver Neoplasms
  • Adenoma
  • Carcinoma
  • Liver Abscess
Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
Group 1
Intervention: Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
April 2013
April 2013   (final data collection date for primary outcome measure)

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.
Both
2 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Japan,   Singapore,   Taiwan
 
NCT01043523
13729
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP