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Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01012674
First received: November 12, 2009
Last updated: April 4, 2013
Last verified: April 2013

November 12, 2009
April 4, 2013
October 2009
December 2010   (final data collection date for primary outcome measure)
Measurement of carotid and vertebral artery stenosis [ Time Frame: 0 - 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01012674 on ClinicalTrials.gov Archive Site
  • 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 - 44 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Carotid Arterial Disease
  • Vertebral Arterial Disease
  • Drug: Dotarem
    Each subject will receive one injection of Dotarem 0.2ml/kg
    Other Name: Gadoterate meglumine
  • Other: TOF MRA
    Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)
Experimental: Dotarem and TOF MRA
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Interventions:
  • Drug: Dotarem
  • Other: TOF MRA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
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 carotid or vertebral arterial disease
  • Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) 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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01012674
DGD-44-049
No
Guerbet
Guerbet
Not Provided
Not Provided
Guerbet
April 2013

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