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

Guerbet

Status and phase: Terminated; Phase 3

Conditions: Renal Artery Stenosis

Treatments: Drug: Gadoterate meglumine (Dotarem); Other: Time of Flight Magnetic Resonance Angiography

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845702

DGD-44-046

Details and patient eligibility

About

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

Full description

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

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Dotarem

Experimental group

Description:

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

Treatment:

Drug: Gadoterate meglumine (Dotarem)

Time Of Flight Magnetic Resonance Angiography

Other group

Description:

Each subject undergo a TOF MRA

Treatment:

Other: Time of Flight Magnetic Resonance Angiography