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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:
ClinicalTrials.gov Identifier:
NCT01012674
First Posted: November 13, 2009
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Guerbet
  Purpose
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Condition Intervention Phase
Cerebral Arterial Diseases Drug: Dotarem Other: TOF MRA Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • 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-44-061).

  • 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-44-061).

  • 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-44-061).


Enrollment: 211
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)

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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): NCT01012674


Locations
United States, Indiana
Guerbet LLC
Bloomington, Indiana, United States, 47403
Sponsors and Collaborators
Guerbet
Investigators
Study Director: Pierre DESCHE, MD Guerbet
  More Information

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01012674     History of Changes
Other Study ID Numbers: DGD-44-049
First Submitted: November 12, 2009
First Posted: November 13, 2009
Results First Submitted: July 29, 2015
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:
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases