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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01043523
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : June 3, 2014
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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.

Condition or disease Intervention/treatment
Liver Neoplasms Adenoma Carcinoma Liver Abscess Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)

Study Design
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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Study Start Date : December 2009
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group 1 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. Vital Signs: Mean Change From Baseline in Heart Rate [ Time Frame: 14 days prior to and up to 24 hours post-Eovist/Primovist MRI ]
  5. 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 ]
  6. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
    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

  4. 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 ]
    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

  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
    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.


Other Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Biospecimen Retention:   None Retained
Pediatric subjects who have had a Eovist/Primovist enhanced MRI for known or suspected focal liver disease

Eligibility Criteria
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Ages Eligible for Study:   2 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric subjects who have had a Primovist/Eovist enhanced MRI for known or suspected focal liver disease
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043523


Locations
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United States, California
Palo Alto, California, United States, 94304
United States, New York
New York, New York, United States, 10032
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cinncinati, Ohio, United States, 45229
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
Italy
Many Locations, Italy
Japan
Many Locations, Japan
Singapore
Many Locations, Singapore
Taiwan
Many Locations, Taiwan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Publications of Results:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01043523    
Other Study ID Numbers: 13729
First Posted: January 6, 2010    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: November 28, 2016
Last Verified: October 2016
Keywords provided by Bayer:
Liver neoplasms
Adenoma
Liver cell carcinoma
Hepatocellular
Liver abscess
Additional relevant MeSH terms:
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Abscess
Liver Abscess
Adenoma
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Suppuration
 Infections
Inflammation
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Abdominal Abscess