Study to Compare MultiHance With Gadovist in Magnetic Resonance Imaging (MRI) of the Brain

Study Overview
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Brief Summary
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This study is being conducted as a phase IV, double-blind, multi-center, randomized, crossover trial aimed at a within-subject comparison of MULTIHANCE and GADOVIST at a dose of 0.1 mmol/kg, in terms of qualitative and quantitative assessment of unenhanced MRI (UE MRI) and contrast-enhanced MRI (CE MRI) for the visualization of brain disease.

Official Title
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Phase IV, Double-Blind, Multi-Center, Randomized, Crossover Study to Compare 0.1 mmol/kg OF MULTIHANCE® WITH 0.1 mmol/kg OF GADOVIST® in Magnetic Resonance Imaging (MRI) of the Brain

Conditions
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Brain Lesions

Intervention / Treatment
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* Drug: MULTIHANCE:
* Drug: GADOVIST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enroll subjects in this study if they meet the following inclusion criteria: 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 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. Exclusion Criteria: Exclude subjects from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed. Are pregnant or lactating females. Exclude the possibility of pregnancy: by testing on site at the institution (serum or urine bHCG) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MULTIHANCE<br>gadobenate dimeglumine | Drug: MULTIHANCE:<br>* MULTIHANCE ® 0.5 M,0.1 mmol/kg<br>|
| Active Comparator: GADOVIST<br>gadobutrol | Drug: GADOVIST<br>* GADOVIST ® 1.0 M,0.1 mmol/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | Day 1 and Day 2 |