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Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00980681
Recruitment Status : Terminated (Lack of recruitment.)
First Posted : September 21, 2009
Results First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Disease Drug: Dotarem Other: Time of Flight Phase 3

Detailed Description:
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg.
 Drug: Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg
Other Name: gadoteric acid, gadoterate meglumine
Time Of Flight
Each subject will undergo a TOF Magnetic Resonance Angiography
 Other: Time of Flight
Each subject will undergo a TOF MRA


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980681


Locations
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United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Guerbet
Investigators
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Study Director: Pierre DESCHE, MD Guerbet
More Information
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00980681    
Other Study ID Numbers: DGD-44-047
First Posted: September 21, 2009    Key Record Dates
Results First Posted: May 26, 2016
Last Update Posted: May 26, 2016
Last Verified: April 2016
Keywords provided by Guerbet:
Renal disease
Contrast agent
MRA
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
 Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action