- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00980681
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
April 19, 2016 updated by: Guerbet
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Indiana
-
Bloomington, Indiana, United States, 47403
- Guerbet LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg.
|
Each subject will receive one injection of Dotarem 0.2ml/kg
Other Names:
|
Other: Time Of Flight
Each subject will undergo a TOF Magnetic Resonance Angiography
|
Each subject will undergo a TOF MRA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pierre DESCHE, MD, Guerbet
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 17, 2009
First Submitted That Met QC Criteria
September 18, 2009
First Posted (Estimate)
September 21, 2009
Study Record Updates
Last Update Posted (Estimate)
May 26, 2016
Last Update Submitted That Met QC Criteria
April 19, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DGD-44-047
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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