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

Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043523
• Other study ID #: 13729
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: May 6, 2014
• Start date: December 2009
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthorityItaly: The Italian Medicines AgencyJapan: Pharmaceuticals and Medical Devices AgencyTaiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 18 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenoma
• Carcinoma
• Liver Abscess
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Italy,  Japan,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Number of 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	No
Other	Improved Border Delineation of the Primary Lesion 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	No
Other	Increased Contrast of Primary Lesion vs Background 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	No
Other	Change in Size of the Primary Lesion 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	No
Other	Change in Information About Lesion Characterization 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	No
Primary	Percentage of Participants With Overall Change in Additional Diagnostic Information Obtained When Comparing the Combined Precontrast/Postcontrast Images With the Precontrast Images.	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	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	No
Primary	Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities at Pre-injection Time Point	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 a-fetoprotein levels.	14 days prior to Eovist/Primovist MRI	Yes
Primary	Number of Participants With Laboratory Values Considered to be Clinically Relevant Values or Abnormalities 24 Hours Post-injection	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 a-fetoprotein levels.	Up to 24 hours post-Eovist/Primovist MRI	Yes
Primary	Vital Signs: Mean Change From Baseline in Heart Rate		14 days prior to and up to 24 hours post-Eovist/Primovist MRI	Yes
Primary	Vital Signs: Mean Change From Baseline in Systolic Blood Pressure		14 days prior to and up to 24 hours post-Eovist/Primovist MRI	Yes
Primary	Vital Signs: Mean Change From Baseline in Diastolic Blood Pressure		14 days prior to and up to 24 hours post-Eovist/Primovist MRI	Yes
Secondary	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	No
Secondary	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	No
Secondary	Change in Number of Nonmalignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images	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	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	No
Secondary	Change in Number of Malignant Lesions Obtained From the Combined Precontrast and Postcontrast Images as Compared With the Precontrast Images	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	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	No
Secondary	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	No
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)		When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	No
Secondary	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	No
Secondary	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	No
Secondary	Sensitivity, Specificity and Accuracy of Blinded Read of Precontrast and Combined Precontrast/Postcontrast Images Based on Final Diagnosis.	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.	When precontrast and postcontrast images are available from all enrolled subjects, on average 1 year post Primovist/Eovist MRI	No

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