Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

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Detailed Description

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Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Conditions

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Renal Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dotarem

Each subject will receive one injection of Dotarem 0.2ml/kg.

Group Type EXPERIMENTAL

Dotarem

Intervention Type DRUG

Each subject will receive one injection of Dotarem 0.2ml/kg

Time Of Flight

Each subject will undergo a TOF Magnetic Resonance Angiography

Group Type OTHER

Time of Flight

Intervention Type OTHER

Each subject will undergo a TOF MRA

Interventions

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Dotarem

Each subject will receive one injection of Dotarem 0.2ml/kg

Intervention Type DRUG

Time of Flight

Each subject will undergo a TOF MRA

Intervention Type OTHER

Other Intervention Names

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gadoteric acid, gadoterate meglumine

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged more than 18 years
* Strongly suspected of having renal arterial disease
* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination

Exclusion Criteria

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No