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

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

Tracking Information

• First Submitted Date: December 13, 2010
• First Posted Date: December 15, 2010
• Last Update Posted Date: January 5, 2012
• Study Start Date: September 2009
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2010)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 13, 2010)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries
• 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
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
• Condition: Carotid, Aortic, Renal or Peripheral Artery Disease

Intervention

• Drug: Gadobenate Dimeglumine
  0.1 mmol/kg, single dose
  Other Name: MultiHance
• Drug: Gadopentetate Dimeglumine
  Double dose of 0.2 mmol/kg
  Other Name: Magnevist

Study Arms

• Experimental: MultiHance contrast agent
  MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg)
  Intervention: Drug: Gadobenate Dimeglumine
• Active Comparator: Magnevist
  Magnevist administered at a dose of 0.2 mmol/kg
  Intervention: Drug: Gadopentetate Dimeglumine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 13, 2010): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01260636
• Other Study ID Numbers: MH-137
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bracco Diagnostics, Inc
• Study Sponsor: Bracco Diagnostics, Inc
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bracco Diagnostics, Inc
• Verification Date: January 2012