Study Stopped
lack of recruitment.
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
1 other identifier
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
September 19, 2012
CompletedMay 20, 2016
April 1, 2016
10 months
February 16, 2009
September 22, 2011
April 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of Non Assessable Renal Artery Segments
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
1 to 7 days
Study Arms (2)
Dotarem
EXPERIMENTALEach subject will receive one injection of Dotarem 0.2 ml/kg.
Time Of Flight Magnetic Resonance Angiography
OTHEREach subject undergo a TOF MRA
Interventions
Each subject will receive one injection of Dotarem 0.2 ml/kg
Each subject will undergo a TOF MRA
Eligibility Criteria
You may qualify if:
- 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,
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guerbetlead
Study Sites (1)
Guerbet LLC
Bloomington, Indiana, 47403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was not completed due to poor enrollment. The statistical analysis was not performed.
Results Point of Contact
- Title
- Pierre Desche, MD, Head of Clinical and Regulatory Affairs
- Organization
- Guerbet
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2009
First Posted
February 18, 2009
Study Start
April 1, 2009
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
May 20, 2016
Results First Posted
September 19, 2012
Record last verified: 2016-04