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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01260636

Acronym

VALUE

Enrollment

120

Registered

2010-12-15

Start date

2009-09-30

Completion date

2011-12-31

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carotid, Aortic, Renal or Peripheral Artery Disease

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

Interventions

DRUGGadobenate Dimeglumine

0.1 mmol/kg, single dose

DRUGGadopentetate Dimeglumine

Double dose of 0.2 mmol/kg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026