Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
|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|
|Primary Completion Date :||December 2010|
|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).
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|