NCT00980681TerminatedPhase 3
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Guerbet
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Percent of Non Assessable Renal Artery Segments
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dotarem
Experimental
Each subject will receive one injection of Dotarem 0.2ml/kg.
Intervention: Dotarem (Drug)
Time Of Flight
Other
Each subject will undergo a TOF Magnetic Resonance Angiography
Intervention: Time of Flight (Other)
Outcomes
Primary Outcomes
Percent of Non Assessable Renal Artery Segments
Time Frame: 1 to 7 days
For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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