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

Cerebral Arterial Diseases Clinical Trial

Official title:

Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010932
• Other study ID #: DGD-44-048
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2009
• Last updated: August 25, 2015
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2015
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cerebral Arterial Diseases

Intervention

Drug:
• Dotarem
Each subject will receive one injection of Dotarem 0.2ml/kg

Other:
• TOF MRA
Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)

Locations

Country	Name	City	State
United States	Guerbet LLC	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Sensitivity and Specificity at Patient Level and at Segment Level Excluding Non-assessable Segments		2-42 days	No
Secondary	Positive and Negative Predictive Values of Dotarem-enhanced MRA and TOF MRA at Patient Level and at Segment Level		2 - 42 days	No
Secondary	Inter and Intra-readers Agreement at the Segment Level		2 -42 days	No
Secondary	Rates of the Different Reasons for Technical Failure for Both MRA Procedures		2 -42 days	No
Secondary	Quality of Images of Both MRA Procedures		2 - 42 days	No
Secondary	Level of Diagnostic Confidence for Both MRA Procedures		2 -42 days	No
Secondary	Size of Stenoses for All Imaging Procedures (MRA and Gold Standard)		2 -42 days	No
Secondary	Duration of Examination		2-42 days	No
Secondary	Rates of the Recommended Clinical Management		2 -42 days	No
Secondary	Adverse Events		0 - 42 days	Yes
Secondary	Blood Sampling		24 hours after Dotarem injection	Yes
Secondary	Tolerance at the Injection Site		24 hours after Dotarem injection	Yes