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

This study has been terminated.
(Lack of recruitment.)
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00980681
First received: September 17, 2009
Last updated: April 19, 2016
Last verified: April 2016
History of Changes

September 17, 2009
April 19, 2016
September 2009
December 2010   (final data collection date for primary outcome measure)
Percent of Non Assessable Renal Artery Segments [ Time Frame: 1 to 7 days ] [ Designated as safety issue: No ]
For each examination (TOF and Dotarem-enhanced MRA) the percent of non-assessable segments will be compared
Measurement of renal artery stenosis [ Time Frame: 0 - 28 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00980681 on ClinicalTrials.gov Archive Site
Not Provided
  • Blood sampling [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Tolerance at the injection site [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 0 - 58 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Renal Disease
  • Drug: Dotarem
    Each subject will receive one injection of Dotarem 0.2ml/kg
    Other Name: gadoteric acid, gadoterate meglumine
  • Other: Time of Flight
    Each subject will undergo a TOF MRA
  • Experimental: Dotarem
    Each subject will receive one injection of Dotarem 0.2ml/kg.
    Intervention: Drug: Dotarem
  • Time Of Flight
    Each subject will undergo a TOF Magnetic Resonance Angiography
    Intervention: Other: Time of Flight
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00980681
DGD-44-047
No
Not Provided
Not Provided
Guerbet
Guerbet
Not Provided
Study Director: Pierre DESCHE, MD Guerbet
Guerbet
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP