Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease
1 other identifier
interventional
222
1 country
1
Brief Summary
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
August 25, 2015
CompletedJune 16, 2016
May 1, 2016
1.2 years
November 9, 2009
July 29, 2015
May 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Technical Failure Rate
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 - 28 days
Sensitivity
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).
2-42 days
Specificity
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).
2 - 42 days
Study Arms (1)
Dotarem and TOF MRA
EXPERIMENTALEach subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guerbetlead
Study Sites (1)
Guerbet LLC
Bloomington, Indiana, 47403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Pierre Desché, MD - VP Head of Development, Medical and Regulatory Affairs
- Organization
- Guerbet
Study Officials
- STUDY DIRECTOR
Pierre DESCHE, MD
Guerbet
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2009
First Posted
November 10, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
June 16, 2016
Results First Posted
August 25, 2015
Record last verified: 2016-05