E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
imaging diagnosis of highly suspected or known brain and/or spine disease, which are known to impair the Blood Brain Barrier Function |
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MedDRA Classification |
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 |
To assess the efficacy of MULTIHANCE at a dose of 0.1 mmol/kg in MRI of the CNS in pediatric patients, in terms of by lesion changes from predose to pre + postdose with regard to the following co-primary visualization endpoints: - Border delineation of lesions - internal morphology of lesions - Contrast enhancement of lesions To assess the safety of MULTIHANCE at a dose of 0.1 mmol/kg in terms of adverse events and changes in vital signs, ECG findings and laboratory findings. |
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E.2.2 | Secondary objectives of the trial |
To assess the efficacy of the contrast agent, MULTIHANCE in terms of by lesion and patient changes, where applicable (changes from predose to pre + postdose and/or predose to postdose), with regard to the following endpoints: - Border delineation of lesions - Visualization of internal morphology of lesions - Contrast enhancement of lesions To assess the efficacy of the contrast agent, MULTIHANCE in terms of lesion changes in the Confidence in Diagnosis |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
All the patients aging between 2 and 17 years,which have known or highly suspected disease of the CNS (brain/spine) and are referred for cranial or spinal MR examination requiring an injection of MR contrast agent and give their consent (or have their parents' consent) |
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E.4 | Principal exclusion criteria |
Are excluded from this study all the following patients: - Have any contraindications to an MR examination - Are undergoing the MR examination in an emergency situation; - Have any known allergy to one or more of the ingredients in the study contrast agents; or have a history of hypersensitivity to any metals or chelates of gadolinium; - Have received any other contrast medium, either intra-vascularly or orally, within the 48 hours before and up to 72 hours following the administration of the investigational product; - Are likely to undergo an invasive examination or intervention within72 hours after the administration of the investigational product; - Have received or have been scheduled to receive an investigational compound and/or medical device within 30 days prior to admission into this study or within 72 hours post-administration of the investigational product; - Are a female who is lactating or pregnant (for females who have started menses; the possibility of pregnancy must be excluded by serum or urine beta-HCG on-site within 24 hours prior to the investigational product administration); - Have sicle cell anemia; patients having moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Border delineation of lesions - Visualization of internal morphology of lesions - Contrast enhancement of lesions |
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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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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 the trial is defined as the last protocol-defined contact of any patient enrolled in the study. Patients will be evaluated up to 72 hours post-dose either by telephone call by the physician or designee or by a scheduled follow-up visit. Since the enrollment is competitive the study will be considered ended when 150 evaluable patients will have been completed |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |