E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with confirmed or highly suspected brain tumor(s) (primary or secondary) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061816 |
E.1.2 | Term | Diagnostic procedure |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029817 |
E.1.2 | Term | Nuclear magnetic resonance imaging brain |
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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 primary objective for this study is: •To show superiority of a 0.1 mmol/kg dose of MULTIHANCE as compared to 0.1 mmol/kg dose of GADOVIST, in terms of the by-subject global diagnostic preference between exams (i.e., based on predose + postdose image sets)
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E.2.2 | Secondary objectives of the trial |
The secondary objectives for this study are: - To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg GADOVIST, in terms of by-subject global diagnostic preference between exams in the following secondary endpoints • Border delineation of lesions • Contrast enhancement of lesions • Lesion Internal Morphology • Extent of Disease - To compare the two different investigational products, 0.1 mmol/kg MULTIHANCE and 0.1 mmol/kg GADOVIST, in terms of changes from predose to postdose for the following quantitative parameters (signal intensity characteristics): • Lesion-to-background (brain) ratio (LBR) by lesion • Contrast-to-noise ratio (CNR) by lesion • Lesion signal intensity enhancement
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject who: • Are at least 18 years of age or older • Are able to give written informed consent and are willing to comply with the protocol requirements • Are scheduled to undergo MRI • Are willing to undergo two MRI procedures within 14 days • Subjects who have confirmed or are highly suspected to have brain tumor(s) (primary or secondary), as determined by: - clinical/neurological symptomatology; - diagnostic testing, such as CT or previous MRI examinations; or - have had recent surgery within 6 months and are to be evaluated for recurrence.
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E.4 | Principal exclusion criteria |
Subjects who: • Are pregnant or lactating females. Exclude the possibility of pregnancy: - by testing on site at the institution (serum or urine βHCG) within 24 h prior to the start of each investigational product administration - by history (i.e., tubal ligation or hysterectomy) - post menopausal with a minimum of 1 year without menses • Have any known allergy to one or more of the ingredients in the investigational product, or have a history of hypersensitivity to any metals • Have congestive heart failure (class IV according to the classification of the New York Heart Association) • Have suffered a stroke within a year • Have received or are scheduled to receive any other contrast medium in the 24 h preceding through the 24 h following Exam 1, and in the 24 h preceding through the 24 h following Exam 2 • Have received or are scheduled to receive an investigational compound and/or medical device within 30 days before admission into the present study, through the 24 h post-administration of the second investigational product. • Have moderate-to-severe renal impairment, defined as a GFR/eGFR < 60 mL/min. • Have been previously entered into this study • Have received or are scheduled for one of the following: - Surgery within three weeks prior to the first examination or between the two examinations - Initiation of steroid therapy between the two examinations - Radiosurgery between the two examinations • Have any contraindications to MRI such as a pace-maker, magnetic material (i.e., surgical clips) or any other conditions that would preclude proximity to a strong magnetic field. • Are suffering from severe claustrophobia • Have any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
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E.5 End points |
E.5.1 | Primary end point(s) |
comparing images acquired with MultiHance and images acquired with Gadovist will be determined the Global diagnostic preference (primary endpoint) obtained in a paired global assessment |
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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 | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |