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

This study has been completed.
Information provided by (Responsible Party):
Guerbet Identifier:
First received: November 9, 2009
Last updated: July 29, 2015
Last verified: April 2013

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

Condition Intervention Phase
Carotid or Vertebral Arterial Disease
Drug: Dotarem
Other: TOF MRA
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

Resource links provided by NLM:

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • 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-44-060).

  • 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-44-060).

  • 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-44-060).

Secondary Outcome Measures:
  • 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 after Dotarem injection ] [ Designated as safety issue: Yes ]
  • Tolerance at the Injection Site [ Time Frame: 24 hours after Dotarem injection ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dotarem and TOF MRA
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01010932

United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Guerbet Identifier: NCT01010932     History of Changes
Other Study ID Numbers: DGD-44-048
Study First Received: November 9, 2009
Results First Received: July 29, 2015
Last Updated: July 29, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Guerbet:
carotid or vertebral artery disease
Contrast agent

Additional relevant MeSH terms:
Gadoterate meglumine
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions processed this record on August 26, 2015