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Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
Sponsor: 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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
315
Start Date
2026-02-02
Completion Date
2027-12-31
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
gadopiclenol
Gadopiclenol enhanced-Magnetic Resonance Angiography
Gadoterate meglumine (Dotarem)
Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography
Locations (41)
University of California Los Angeles (UCLA)
Los Angeles, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
Northshore - Evanston Hospital
Evanston, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Department of Radiology and Nuclear Medicine, University Hospital Brno
Brno, Czechia
Motol University Hospital
Prague, Czechia
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, France
Hôpital Cardiovasculaire et Pneumologique
Bron, France
CHU Dijon Bourgogne
Dijon, France
CHU de Poitiers
Poitiers, France
Charité - Universitätsmedizin Berlin
Berlin, Germany
University Hospital Bonn
Bonn, Germany
UH Essen
Essen, Germany
University Hospital of Saarland
Homburg, Germany
Klinik fuer Diagnostische Radiologie and Neuroradiologie
Kiel, Germany
Department of Neuroradiology, UKSH Campus Lübeck
Lübeck, Germany
LMU University Hospital
München, Germany
Semmelweis University - Budapest
Budapest, Hungary
University of Debrecen - Debrecen
Debrecen, Hungary
University of Pecs Clinical Centre
Pécs, Hungary
Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII
Bergamo, Italy
Azienda Ospedaliera di Monserrato
Cagliari, Italy
ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara
Chieti, Italy
Department of Diagnostic Imaging, Humanitas Research Hospital
Milan, Italy
Diagnostica per Immagini e Interventistica Ospedale Umberto I
Roma, Italy
Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome
Roma, Italy
Ospedale Ca' Foncello
Treviso, Italy
University Hospital No.1, Department of Radiology and Diagnostic Imagine
Bydgoszcz, Poland
Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, Poland
Medical University Lublin, Diagnostic Imaging Department
Lublin, Poland
Yonsei University Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Seoul St. Mary's Hospital
Seoul, Seocho-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Ajou University Hospital
Gyeonggi-do, Suwon-si, South Korea
Diagnòstic per la Imatge
Barcelona, Spain
Hospital Clínico San Cecilio
Granada, Spain
Hospital Nuestra, Resonancia Magnetica NTRA
Madrid, Spain