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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012674
Other study ID # DGD-44-049
Secondary ID
Status Completed
Phase Phase 3
First received November 12, 2009
Last updated August 25, 2015
Start date October 2009
Est. completion date December 2010

Study information

Verified date April 2013
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 211
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/1.73mĀ²)

- Contraindication to MRI

- Acute renal dysfunction within the 6 months preceding DotaremĀ®-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


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-44-061). 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-44-061). 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-44-061). 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 No
Secondary Tolerance at the Injection Site 24 hours No
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