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: August 25, 2015
Last verified: April 2013

November 12, 2009
August 25, 2015
October 2009
December 2010   (final data collection date for primary outcome measure)
  • Technical Failure Rate [ Time Frame: 2 - 28 days ] [ Designated as safety issue: No ]
    Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-061).
  • Sensitivity [ Time Frame: 2-42 days ] [ Designated as safety issue: No ]
    Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).
  • Specificity [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
    Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-061).
Measurement of carotid and vertebral artery stenosis [ Time Frame: 0 - 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01012674 on ClinicalTrials.gov Archive Site
  • Sensitivity and Specificity at Patient Level and at Segment Level Excluding Non-assessable Segments [ Time Frame: 2-42 days ] [ Designated as safety issue: No ]
  • Positive and Negative Predictive Values of Dotarem-enhanced MRA and TOF MRA At Patient Level and at Segment Level [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Inter and Intra-readers Agreement at the Segment Level [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Rates of the Different Reasons for Technical Failure for Both MRA Procedures [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Quality of Images of Both MRA Procedures [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Level of Diagnostic Confidence for Both MRA Procedures [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Size of Stenoses for All Imaging Procedures (MRA and Gold Standard) [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Duration of Examination [ Time Frame: 2- 42 days ] [ Designated as safety issue: No ]
  • Rates of the Recommended Clinical Management [ Time Frame: 2 - 42 days ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 0 - 42 days ] [ Designated as safety issue: Yes ]
  • 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 ]
  • 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 ]
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.

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Cerebral Arterial Diseases
  • 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
Study Director: Pierre DESCHE, MD Guerbet
Guerbet
April 2013

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