E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Magnetic Resonance Imaging |
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E.1.1.1 | Medical condition in easily understood language |
Magnetic Resonance Imaging |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10072304 |
E.1.2 | Term | Nuclear magnetic resonance imaging liver |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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.) |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Number of participants with additional diagnostic information from combined (pre-contrast and post-contrast) compared with pre-contrast images
• Number of participants with adverse events as a measure of safety and tolerability
• Number of participants with serious adverse events as a measure of safety and tolerability |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
• Up to 1 year after injection
• Up to 24 hours after injection
• Up to 6 months after injection |
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E.5.2 | Secondary end point(s) |
• Number of lesions detected for the pre-contrast images
• Number of lesions detected for the combined images
• Number of participants with contrast enhancement of the biliary system for the combined images
• Contrast enhancement of the biliary system for the combined images assessed by yes or no question
• Number of participants with visualization of the biliary system for the pre-contrast images
• Number of participants with visualization of the biliary system for the combined images
• Number of participants with diagnostic confidence for the pre-contrast images
• Number of participants with diagnostic confidence for the combined images |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 1 year after injection |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study as a whole will be reached when the clean database is available. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |