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
Results First Received: February 24, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Liver Neoplasms
Adenoma
Carcinoma
Liver Abscess
Intervention: Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pediatric subjects (> 2 months and < 18 years of age), who underwent a contrast-enhanced (CE) liver magnetic resonance imaging (MRI) with Eovist/Primovist because of suspected or known focal liver lesions, and who had evaluable safety and efficacy data.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 52 subjects that were identified by the investigators for participation in this observational/retrospective study, 51 were included in the efficacy analysis. One subject (22001-0005) did not have unenhanced images. The safety analysis was performed on all 52 subjects.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Gadoxetic Acid Disodium (Eovist, BAY86-4873)  
STARTED     52  
Participants With Unenhanced Images     51  
COMPLETED     52  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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

Baseline Measures
    Gadoxetic Acid Disodium (Eovist, BAY86-4873)  
Number of Participants  
[units: participants]
  52  
Age, Customized  
[units: Participants]
 
>2 months to ≤2 years     14  
>2 years to ≤12 years     25  
>12 years to <18 years     13  
Gender  
[units: Participants]
 
Female     28  
Male     24  
Indication for magnetic resonance imaging (MRI)  
[units: Participants]
 
Suspected or known focal liver lesions     49  
Cystic fibrosis     1  
Biliary atresia     1  
No clinical indication     1  
Physical examination performed at preinjection timepoint [1]
[units: Participants]
 
Yes     36  
No     16  
Physical examination performed at postinjection timepoint [2]
[units: Participants]
 
Yes     35  
No     17  
[1] Number of participants received physical examination within14 days prior to injection.
[2] Number of participants received physical examination up to 24 hours after injection of Eovist/Primovist. Changes in the physical examination were recorded as adverse events (AEs).



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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.  Primary:   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.  Primary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  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)   [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Secondary:   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 ]

16.  Other Pre-specified:   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 ]

17.  Other Pre-specified:   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 ]

18.  Other Pre-specified:   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 ]

19.  Other Pre-specified:   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 ]

20.  Other Pre-specified:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01043523     History of Changes
Other Study ID Numbers: 13729
Study First Received: January 4, 2010
Results First Received: February 24, 2014
Last Updated: May 6, 2014
Health Authority: Singapore: Health Sciences Authority
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan: Department of Health
United States: Food and Drug Administration