Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

Study Overview
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Brief Summary
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To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries

Official Title
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A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries

Conditions
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Carotid, Aortic, Renal or Peripheral Artery Disease

Intervention / Treatment
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* Drug: Gadobenate Dimeglumine
* Drug: Gadopentetate Dimeglumine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 yrs of age or older referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries Able to provide written informed consent and comply with protocol requirements Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol Exclusion Criteria: pregnant or lactating females Known allergy to one or more of the ingredients in the products under investigation Significant congestive heart failure ( Class IV) Moderate to severe chronic kidney disease Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures Vascular stents in vessels of interest Received another contrast agent in the 24 hrs preceding or proceeding each exam Previously entered into the study Contraindications to MRI Severe Claustrophobia Undergone DSA between the two exams

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MultiHance contrast agent<br>MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg) | Drug: Gadobenate Dimeglumine<br>* 0.1 mmol/kg, single dose<br>* Other names: MultiHance;|
| Active Comparator: Magnevist<br>Magnevist administered at a dose of 0.2 mmol/kg | Drug: Gadopentetate Dimeglumine<br>* Double dose of 0.2 mmol/kg<br>* Other names: Magnevist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Preference | Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference | Immediately post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety comparison of two diagnostic agents | to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries | UP to 24 hours post dose of each contrast agent |