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

Phase 3

Completed

• Conditions: Carotid, Aortic, Renal or Peripheral Artery Disease
• Interventions: Drug: Gadopentetate Dimeglumine; Drug: Gadobenate Dimeglumine

• Registration Number: NCT01260636
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-04
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Magnevist	Gadopentetate Dimeglumine	Magnevist administered at a dose of 0.2 mmol/kg
MultiHance contrast agent	Gadobenate Dimeglumine	MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)

Primary Outcome Measures

Name	Time	Method
Diagnostic Preference	Immediately post dose	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radiology Department Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, China