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

Guerbet222 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

222

Conditions

Cerebral Arterial Diseases

Interventions

DotaremDRUG

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

TOF MRAOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Guerbet LLC

Bloomington, Indiana, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 2 - 42 days

Data from ClinicalTrials.gov

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