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

NCT01043523 | Completed Results

• 1 other identifier: 13729
• Study Type: observational
• Target: 52
• Locations: 5 countries
• Sites: 9

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.

Conditions

Liver Neoplasms; Adenoma; Carcinoma; Liver Abscess

Keywords

Liver neoplasms; Adenoma; Liver cell carcinoma; Hepatocellular; Liver abscess

Outcome Measures

Primary Outcomes (6)

• 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

• 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 α-fetoprotein levels.

  14 days prior to Eovist/Primovist MRI

• 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 α-fetoprotein levels.

  Up to 24 hours post-Eovist/Primovist MRI

• 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 Systolic Blood Pressure

  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

Secondary Outcomes (9)

• 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 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 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 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

Other Outcomes (5)

• 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

• 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

• 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

Study Arms (1)

Group 1

Drug: Gadoxetic Acid Disodium (Eovist, BAY86-4873)

Interventions

Gadoxetic Acid Disodium (Eovist, BAY86-4873) DRUG

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

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (9)

Unknown Facility

Palo Alto, California, 94304, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Cinncinati, Ohio, 45229, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Japan

Location

Unknown Facility

Many Locations, Singapore

Location

Unknown Facility

Many Locations, Taiwan

Location

Related Publications (1)

• Geller J, Kasahara M, Martinez M, Soresina A, Kashanian F, Endrikat J. Safety and Efficacy of Gadoxetate Disodium-Enhanced Liver MRI in Pediatric Patients Aged >2 Months to <18 Years-Results of a Retrospective, Multicenter Study. Magn Reson Insights. 2016 Jul 21;9:21-8. doi: 10.4137/MRI.S39091. eCollection 2016.

  PMID: 27478381 RESULT

Biospecimen

Retention: NONE RETAINED

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

MeSH Terms

Conditions

Liver Neoplasms; Adenoma; Carcinoma; Liver Abscess; Carcinoma, Hepatocellular

Interventions

gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Abdominal Abscess; Abscess; Suppuration; Infections; Adenocarcinoma

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 6, 2010
• Study Start: December 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 28, 2016
• Results First Posted: June 3, 2014

Record last verified: 2016-10

Locations

IT (1); US (5); JP (1); SG (1); TW (1)