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

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ClinicalTrials.gov Identifier: NCT01260636
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : January 5, 2012
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Study Description
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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

Condition or disease Intervention/treatment Phase
Carotid, Aortic, Renal or Peripheral Artery Disease Drug: Gadobenate Dimeglumine Drug: Gadopentetate Dimeglumine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MultiHance contrast agent
MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)
 Drug: Gadobenate Dimeglumine
0.1 mmol/kg, single dose
Other Name: MultiHance
Active Comparator: Magnevist
Magnevist administered at a dose of 0.2 mmol/kg
 Drug: Gadopentetate Dimeglumine
Double dose of 0.2 mmol/kg
Other Name: Magnevist


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic Preference [ Time Frame: 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 :
  1. Safety comparison of two diagnostic agents [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260636


Locations
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China
Radiology Department Zhongshan Hospital, Fudan University
Shanghai, China
Sponsors and Collaborators
Bracco Diagnostics, Inc
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01260636    
Other Study ID Numbers: MH-137
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases