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

Guerbet

Status and phase: Terminated; Phase 3

Conditions: Renal Disease

Treatments: Other: Time of Flight; Drug: Dotarem

Study type: Interventional

Funder types: Industry

Identifiers

NCT00980681

DGD-44-047

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: 13 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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13 participants in 2 patient groups

Dotarem

Experimental group

Description:

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

Treatment:

Drug: Dotarem

Time Of Flight

Other group

Description:

Each subject will undergo a TOF Magnetic Resonance Angiography

Treatment:

Other: Time of Flight