Magnetic resonance imaging of the liver with Eovist/Primovist in children 0 to 2 months of age

Conditions: Magnetic Resonance Imaging
MedDRA version: 18.0Level: PTClassification code 10072304Term: Nuclear magnetic resonance imaging liverSystem Organ Class: 10022891 - Investigations
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Registration Number: EUCTR2012-000952-32-Outside-EU/EEA

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 10

Inclusion Criteria

- Age 0-2 months (must be gestational age 37 to 41 weeks) - Scheduled to undergo routine contrast-enhanced liver MRI - Able to comply with the study procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of this study are to evaluate the safety, efficacy (imaging data), and plasma gadolinium concentrations after administration of Eovist/Primovist in pediatric subjects 0 to 2 months of age with known or suspected hepatobiliary pathology who are undergoing contrast-enhanced MRI of the liver.;Secondary Objective: Not applicable;Primary end point(s): • Number of participants with additional diagnostic information from combined (pre-contrast and post-contrast) compared with pre-contrast images<br>• Number of participants with adverse events as a measure of safety and tolerability<br>• Number of participants with serious adverse events as a measure of safety and tolerability ;Timepoint(s) of evaluation of this end point: • Up to 1 year after injection<br>• Up to 24 hours after injection<br>• Up to 6 months after injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Number of lesions detected for the pre-contrast images<br>• Number of lesions detected for the combined images<br>• Number of participants with contrast enhancement of the biliary system for the combined images<br>• Contrast enhancement of the biliary system for the combined images assessed by yes or no question<br>• Number of participants with visualization of the biliary system for the pre-contrast images<br>• Number of participants with visualization of the biliary system for the combined images<br>• Number of participants with diagnostic confidence for the pre-contrast images<br>• Number of participants with diagnostic confidence for the combined images ;Timepoint(s) of evaluation of this end point: Up to 1 year after injection