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

NCT01260636 | Completed Phase 3

• 1 other identifier: MH-137
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Carotid, Aortic, Renal or Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety comparison of two diagnostic agents

  UP to 24 hours post dose of each contrast agent

Study Arms (2)

MultiHance contrast agent

EXPERIMENTAL

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

Drug: Gadobenate Dimeglumine

Magnevist

ACTIVE COMPARATOR

Magnevist administered at a dose of 0.2 mmol/kg

Drug: Gadopentetate Dimeglumine

Interventions

Gadobenate Dimeglumine DRUG

0.1 mmol/kg, single dose

Also known as: MultiHance

MultiHance contrast agent

Gadopentetate Dimeglumine DRUG

Double dose of 0.2 mmol/kg

Also known as: Magnevist

Magnevist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Radiology Department Zhongshan Hospital, Fudan University

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 23042922 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

gadobenic acid; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: September 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

CN (1)