Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
|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.|
|ClinicalTrials.gov Identifier: NCT01010932|
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : August 25, 2015
Last Update Posted : June 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Arterial Diseases||Drug: Dotarem Other: TOF MRA||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Dotarem and TOF MRA
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Each subject will receive one injection of Dotarem 0.2ml/kg
Other Name: Gadoterate meglumineOther: TOF MRA
Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)
- 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).
- 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).
- 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).
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
|United States, Indiana|
|Bloomington, Indiana, United States, 47403|
|Study Director:||Pierre DESCHE, MD||Guerbet|