Back to resultsRenal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Primary Purpose
Renal Artery Stenosis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Gadoterate meglumine (Dotarem)
Time of Flight Magnetic Resonance Angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Artery Stenosis focused on measuring Renal artery stenosis, Contrast agent, MRA
Eligibility Criteria
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,
Sites / Locations
- Guerbet LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Dotarem
Time Of Flight Magnetic Resonance Angiography
Arm Description
Each subject will receive one injection of Dotarem 0.2 ml/kg.
Each subject undergo a TOF MRA
Outcomes
Primary Outcome Measures
Percent of Non Assessable Renal Artery Segments
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00845702
Brief Title
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Official Title
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of recruitment.
Study Start Date
April 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Artery Stenosis
Keywords
Renal artery stenosis, Contrast agent, MRA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dotarem
Arm Type
Experimental
Arm Description
Each subject will receive one injection of Dotarem 0.2 ml/kg.
Arm Title
Time Of Flight Magnetic Resonance Angiography
Arm Type
Other
Arm Description
Each subject undergo a TOF MRA
Intervention Type
Drug
Intervention Name(s)
Gadoterate meglumine (Dotarem)
Intervention Description
Each subject will receive one injection of Dotarem 0.2 ml/kg
Intervention Type
Other
Intervention Name(s)
Time of Flight Magnetic Resonance Angiography
Intervention Description
Each subject will undergo a TOF MRA
Primary Outcome Measure Information:
Title
Percent of Non Assessable Renal Artery Segments
Description
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
Time Frame
1 to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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,
Facility Information:
Facility Name
Guerbet LLC
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
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