Clinical trial NCT02084628: Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent
Official title: Open-label, Multi-center Study to Evaluate the Safety, Efficacy, and Plasma Gadolinium Concentrations After an Intravenous Injection of 0.1 mL/kg Body Weight Eovist/Primovist for Enhanced Magnetic Resonance Imaging (MRI) of the Liver in Children 0 to 2 Months of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Magnetic Resonance Imaging
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 1
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world.

The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.

Detailed description: In order to minimize bias in assessment of the images, blinded reading of the MR images will be performed by 2 blinded readers. The blinded readers will be independent board-certified pediatric radiologists who have no knowledge about the subjects and are not affiliated with any of the clinical sites.

Eligibility criteria: Inclusion Criteria:

* Age 0-2 months (must be gestational age 37 to 41 weeks)
* Scheduled to undergo routine contrast-enhanced liver MRI
* Able to comly with the study procedures

Exclusion Criteria:

* Scheduled for any intervention (except lumbar puncture and bone marrow aspiration) during the study period
* If receiving chemotherapy, may have a change in treatment during the study period
* Contraindication for MRI
* Renal insufficiency (estimated glomerular filtration rate \< 80% of age-adjusted normal mean value using the Schwartz formula)
* Acute renal failure
* Clinically relevant abnormal laboratory parameter, ie, greater than 3 times the upper limit of the normal range, in particular, liver enzymes and renal function. (Note: if elevations in liver enzyme levels are consistent with the underlying hepatobiliary disease, then the subject may be enrolled.)

Primary outcomes:
measure: Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
measure: Number of Subjects With Adverse Events
timeFrame: From the signing of the informed consent form until the 6 month post MRI follow-up
measure: Number of Subjects With Serious Adverse Events
timeFrame: From the signing of the informed consent form until the 6 month post MRI follow-up
Secondary outcomes:
measure: Number of Lesions Detected for the Pre-contrast Images
timeFrame: Images were taken pre-injection
measure: Number of Lesions Detected for the Combined Images
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
measure: Contrast Enhancement of the Liver for the Combined Images Assessed by Yes or no Question
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
measure: Contrast Enhancement of the Biliary System for the Combined Images Assessed by Yes or no Question
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
measure: Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by Yes or no Question
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
measure: Change in Diagnosis for the Combined Images Compared With Precontrast Images
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
measure: Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by Yes or no Question
timeFrame: Images were taken pre-injection and post-injection (within about 15 minutes)
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Brooklyn
country: United States
state: New York
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: