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

Phase 3

Completed

• Conditions: Cerebral Arterial Diseases
• Interventions: Drug: Dotarem; Other: TOF MRA

• Registration Number: NCT01010932
• Lead Sponsor: Guerbet

Brief Summary

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

Detailed Description

Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Disposition First Submitted: 2012-11-09
• Disposition First Submitted QC: 2012-11-09
• Disposition First Posted: 2012-11-15
• Results First Submitted: 2015-07-29
• Results First Submitted QC: 2015-07-29
• Results First Posted: 2015-08-25
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dotarem and TOF MRA	TOF MRA	Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Dotarem and TOF MRA	Dotarem	Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Primary Outcome Measures

Name	Time	Method
Technical Failure Rate	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).
Specificity	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).
Sensitivity	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).

Trial Locations

Locations (1)

Guerbet LLC; 🇺🇸 Bloomington, Indiana, United States