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

Phase 3TerminatedNCT00845702

Guerbet33 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Renal Artery Stenosis

Interventions

Gadoterate meglumine (Dotarem)DRUG

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

Time of Flight Magnetic Resonance AngiographyOTHER

Each subject will undergo a TOF MRA

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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,

Locations (1)

Guerbet LLC

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

Percent of Non Assessable Renal Artery Segments

For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared

Time frame: 1 to 7 days

Data from ClinicalTrials.gov

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