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

Primary Purpose

Carotid, Aortic, Renal or Peripheral Artery Disease

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Gadobenate Dimeglumine
Gadopentetate Dimeglumine
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carotid, Aortic, Renal or Peripheral Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radiology Department Zhongshan Hospital, Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MultiHance contrast agent

Magnevist

Arm Description

MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)

Magnevist administered at a dose of 0.2 mmol/kg

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 13, 2010
Last Updated
January 4, 2012
Sponsor
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01260636
Brief Title
Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries
Acronym
VALUE
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid, Aortic, Renal or Peripheral Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MultiHance contrast agent
Arm Type
Experimental
Arm Description
MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)
Arm Title
Magnevist
Arm Type
Active Comparator
Arm Description
Magnevist administered at a dose of 0.2 mmol/kg
Intervention Type
Drug
Intervention Name(s)
Gadobenate Dimeglumine
Other Intervention Name(s)
MultiHance
Intervention Description
0.1 mmol/kg, single dose
Intervention Type
Drug
Intervention Name(s)
Gadopentetate Dimeglumine
Other Intervention Name(s)
Magnevist
Intervention Description
Double dose of 0.2 mmol/kg
Primary Outcome Measure Information:
Title
Diagnostic Preference
Description
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
Time Frame
Immediately post dose
Secondary Outcome Measure Information:
Title
Safety comparison of two diagnostic agents
Description
to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries
Time Frame
UP to 24 hours post dose of each contrast agent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Radiology Department Zhongshan Hospital, Fudan University
City
Shanghai
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23042922
Citation
Li Y, Li X, Li D, Lu J, Xing X, Yan F, Li Y, Wang X, Iezzi R, De Cobelli F. Multicenter, intraindividual comparison of single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine for MR angiography of the supra-aortic arteries (the Supra-Aortic VALUE study). AJNR Am J Neuroradiol. 2013 Apr;34(4):847-54. doi: 10.3174/ajnr.A3298. Epub 2012 Oct 4.
Results Reference
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Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries

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