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

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ClinicalTrials.gov Identifier: NCT01010932
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : August 25, 2015
Last Update Posted : June 16, 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 in patients suffering from carotid or vertebral arterial disease.

Condition or disease Intervention/treatment Phase
Cerebral Arterial Diseases Drug: Dotarem Other: TOF MRA Phase 3

Detailed Description:
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 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 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)


Outcome Measures
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Primary Outcome Measures :
  1. Technical Failure Rate [ Time Frame: 2 - 28 days ]
    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).

  2. Sensitivity [ Time Frame: 2-42 days ]
    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).

  3. Specificity [ Time Frame: 2 - 42 days ]
    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).


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 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
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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): NCT01010932


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: NCT01010932    
Other Study ID Numbers: DGD-44-048
First Posted: November 10, 2009    Key Record Dates
Results First Posted: August 25, 2015
Last Update Posted: June 16, 2016
Last Verified: May 2016
Keywords provided by Guerbet:
carotid or vertebral artery disease
Contrast agent
MRA
Additional relevant MeSH terms:
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Cerebral Arterial Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action