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Completed

NCT Number: NCT01012674

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

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

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Key information

Conditions

Cerebral Arterial Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guerbet LLC

Bloomington, Indiana, 47403, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DOTAREM

Drug

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

Other names: Gadoterate meglumine

TOF MRA

Other

Each subject will undergo a Time Of Flight Magnetic Resonance Angiography (TOF MRA)

Primary outcomes

  1. 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-44-061).

  2. 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-44-061).

  3. 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-44-061).

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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