Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Phase 3
Terminated
- Conditions
- Renal Artery Stenosis
- Interventions
- Other: Time of Flight Magnetic Resonance Angiography
- Registration Number
- NCT00845702
- Lead Sponsor
- Guerbet
- Brief Summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
- Detailed Description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
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,
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Time Of Flight Magnetic Resonance Angiography Time of Flight Magnetic Resonance Angiography Each subject undergo a TOF MRA Dotarem Gadoterate meglumine (Dotarem) Each subject will receive one injection of Dotarem 0.2 ml/kg.
- Primary Outcome Measures
Name Time Method Percent of Non Assessable Renal Artery Segments 1 to 7 days For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guerbet LLC
🇺🇸Bloomington, Indiana, United States