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
Condition(s) studied
Investigational drug(s) / intervention(s)
gadopiclenol: Gadopiclenol enhanced-Magnetic Resonance Angiography
Gadoterate meglumine (Dotarem): Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography
Study 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
Eligibility
Primary outcome measure(s)
- Non-inferiority — 30 days
To demonstrate the non-inferiority of gadopiclenol-enhanced Magnetic Resonance Angiography (MRA) compared to gadoterate meglumine enhanced MRA at 0.1 mmol/kg body weight in terms of sensitivity and specificity for detecting clinically significant steno-occlusive disease at segment level using Computerized Tomography Angiography (CTA) and/or Intra-arterial-Digital Subtraction Angiography (IA-DSA) findings as Standard of Truth.
Trial sites (43)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama | Birmingham | Alabama | Not Yet Recruiting |
| University of California Los Angeles (UCLA) | Los Angeles | California | Not Yet Recruiting |
| UCHealth University of Colorado Hospital | Aurora | Colorado | Not Yet Recruiting |
| Northshore - Evanston Hospital | Evanston | Illinois | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Not Yet Recruiting |
| University of Washington | Seattle | Washington | Not Yet Recruiting |
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | Not Yet Recruiting |
| Seaman MRI research centre | Calgary | Canada | Not Yet Recruiting |
| Department of Radiology and Nuclear Medicine, University Hospital Brno | Brno | Czechia | Not Yet Recruiting |
| Motol University Hospital | Prague | Czechia | Not Yet Recruiting |
| CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | France | Recruiting |
| Hôpital Cardiovasculaire et Pneumologique | Bron | France | Recruiting |
| CHU Dijon Bourgogne | Dijon | France | Recruiting |
| CHU de Poitiers | Poitiers | France | Not Yet Recruiting |
| Charité - Universitätsmedizin Berlin | Berlin | Germany | Not Yet Recruiting |
| University Hospital Bonn | Bonn | Germany | Not Yet Recruiting |
| University of Bielefeld, Klinikum Lippe | Detmold | Germany | Not Yet Recruiting |
| UH Essen | Essen | Germany | Not Yet Recruiting |
| University Hospital of Saarland | Homburg | Germany | Not Yet Recruiting |
| Klinik fuer Diagnostische Radiologie and Neuroradiologie | Kiel | Germany | Recruiting |
| Department of Neuroradiology, UKSH Campus Lübeck | Lübeck | Germany | Not Yet Recruiting |
| Semmelweis University - Budapest | Budapest | Hungary | Recruiting |
| University of Debrecen - Debrecen | Debrecen | Hungary | Recruiting |
| University of Pecs Clinical Centre | Pécs | Hungary | Recruiting |
| Albert Szent-Györgyi Medical Center | Szeged | Hungary | Not Yet Recruiting |
| Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII | Bergamo | Italy | Recruiting |
| Azienda Ospedaliera di Monserrato | Cagliari | Italy | Recruiting |
| ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara | Chieti | Italy | Recruiting |
| Department of Diagnostic Imaging, Humanitas Research Hospital | Milan | Italy | Not Yet Recruiting |
| Diagnostica per Immagini e Interventistica Ospedale Umberto I | Roma | Italy | Recruiting |
| Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome | Roma | Italy | Recruiting |
| Ospedale Ca' Foncello | Treviso | Italy | Recruiting |
| University Hospital No.1, Department of Radiology and Diagnostic Imagine | Bydgoszcz | Poland | Not Yet Recruiting |
| Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku | Gdansk | Poland | Not Yet Recruiting |
| Medical University Lublin, Diagnostic Imaging Department | Lublin | Poland | Not Yet Recruiting |
| Yonsei University Gangnam Severance Hospital | Seoul | Gangnam-gu | Not Yet Recruiting |
| Seoul National University Hospital | Seoul | Jongno-gu | Not Yet Recruiting |
| Seoul St. Mary's Hospital | Seoul | Seocho-gu | Not Yet Recruiting |
| Asan Medical Center | Seoul | Songpa-gu | Not Yet Recruiting |
| Ajou University Hospital | Gyeonggi-do | Suwon-si | Not Yet Recruiting |
+ 3 more sites — see the full list on the official registry below.
More Guerbet trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07348640 on ClinicalTrials.gov ↗ ← All trials in Italy