A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
Guerbet
Summary
Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI
Description
To prospectively compare the diagnostic performance of gadopiclenol with gadoterate meglumine given at a dose of 0.1 mmol/kg in the diagnosis and evaluation of vascular diseases of supra-aortic (carotid/vertebrobasilar), peripheral or abdominal/renal arteries using commercial MRI scanners and MRA sequences.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients 18 years of age or older willing to participate in the trial and follow all study procedures specified in the protocol. 2. Patient having read the information in the ICF and having provided his/her consent to participate in writing by dating and signing the ICF prior to any trial related procedure being conducted. 3. Patient with suspected steno-occlusive disease in supra-aortic (carotid/vertebrobasilar) (a), peripheral (b) or abdominal/renal (c) arteries based on: 1. clinical signs and symptoms including but not limited to prior stroke, tran…
Interventions
- Druggadopiclenol
Gadopiclenol enhanced-Magnetic Resonance Angiography
- DrugGadoterate meglumine (Dotarem)
Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography
Locations (41)
- University of California Los Angeles (UCLA)Los Angeles, California
- UCHealth University of Colorado HospitalAurora, Colorado
- Northshore - Evanston HospitalEvanston, Illinois
- Mayo ClinicRochester, Minnesota
- Houston Methodist HospitalHouston, Texas
- University of WashingtonSeattle, Washington