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NCT07348640PHASE3Recruiting

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

Guerbet

Start Date

7/28/2026

Completion Date

12/31/2027

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

Detailed 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 Criteria

Age Range: 18 years to No maximum

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, transient ischemic attack (TIA), amaurosis fugax (transient monocular blindness) and/or previous diagnostic tests (CTA, IA-DSA, or ultrasound) or 2. symptoms of lower-extremity arterial disease (stages II-IV according to the Leriche-Fontaine classification, or 1 to 6 according to Rutherford classification 113 and/or confirmed by previous imaging (Doppler ultrasound, CTA, MRA, IADSA) or 3. suspected renovascular hypertension based on one or more of the following criteria: i. hypertension refractory to standard therapy ii. acute worsening of pre-existing hypertension iii. abrupt onset of sustained, moderate to severe hypertension at age \<35 years suggestive of fibromuscular dysplasia (FMD) iv. progressive renal insufficiency (creatinine \> 2 mg/dL; no other apparent cause of progressive renal failure based on routine medical history, physical examination, 24-h urine collection and urinary protein excretion) v. abnormal/inconclusive renal doppler ultrasound. vi. other criteria (to be specified) 4. Are scheduled for or had undergone CTA and/or IA-DSA according to imaging standards to cover the supra-aortic (carotid/vertebrobasilar) and/or peripheral and/or abdominal/renal territory described in this protocol. Exclusion Criteria: 1. Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential: * by testing on site at the institution (serum βHCG or urine) * by surgical history (e.g., tubal ligation or hysterectomy) * post-menopausal with a minimum 1 year without menses. 2. Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs. 3. Has severe renal impairment defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula. 4. Has known or suspected acute kidney injury (AKI) based on: a. Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours or b. Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within prior 7 days or c. Urine volume \< 0.5 mL/kg/h for 6 hours 5. Has received any contrast agent (for MRI, CT, DSA) prior to the first IMP administration or is scheduled to receive any contrast agent between the two MRA or after the second IMP administration. 6. Has received or is scheduled for therapeutic intervention (e.g., endovascular therapy, vascular surgery, etc.) of any kind for vascular disease in the arterial territory of interest performed between the 2 MRA procedures or between the study MRAs and the CTA/IADSA procedures when applicable. 7. Has any contraindications to MRI. 8. Is suffering from severe claustrophobia. 9. Has received an investigational drug or medical device before admission into this study or scheduled to receive any investigational treatment in the course of the trial. 10. Was previously included in this trial. 11. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

Interventions

DRUG

gadopiclenol

DRUG

Gadoterate meglumine (Dotarem)

Interested in This Trial?

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Conditions

Steno-occlusive Disease

Locations

University of Alabama

Birmingham, Alabama 35233

United States

University of California Los Angeles (UCLA)

Los Angeles, California 90095-7206

United States

UCHealth University of Colorado Hospital

Aurora, Colorado 80045

United States

Northshore - Evanston Hospital

Evanston, Illinois 60201

United States

Mayo Clinic

Rochester, Minnesota 55901

United States

University of Washington

Seattle, Washington 98185

United States

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec H2X 3J2

Canada

Seaman MRI research centre

Calgary,

Canada

Department of Radiology and Nuclear Medicine, University Hospital Brno

Brno, 625 00

Czechia

Motol University Hospital

Prague, 150 06

Czechia

CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076

France

Hôpital Cardiovasculaire et Pneumologique

Bron, 69500

France

CHU Dijon Bourgogne

Dijon, 21079

France

CHU de Poitiers

Poitiers, 86000

France

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

University Hospital Bonn

Bonn,

Germany

University of Bielefeld, Klinikum Lippe

Detmold, 32756

Germany

UH Essen

Essen, 45147

Germany

University Hospital of Saarland

Homburg, 66421

Germany

Klinik fuer Diagnostische Radiologie and Neuroradiologie

Kiel, D-24105

Germany

Department of Neuroradiology, UKSH Campus Lübeck

Lübeck, 23538

Germany

Semmelweis University - Budapest

Budapest, 1122

Hungary

University of Debrecen - Debrecen

Debrecen,

Hungary

University of Pecs Clinical Centre

Pécs, 7623

Hungary

Albert Szent-Györgyi Medical Center

Szeged, 6725

Hungary

Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII

Bergamo, 34127

Italy

Azienda Ospedaliera di Monserrato

Cagliari, 09124

Italy

ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara

Chieti,

Italy

Department of Diagnostic Imaging, Humanitas Research Hospital

Milan, 20089

Italy

Diagnostica per Immagini e Interventistica Ospedale Umberto I

Roma, 00161

Italy

Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome

Roma, 00168

Italy

Ospedale Ca' Foncello

Treviso, 31100

Italy

University Hospital No.1, Department of Radiology and Diagnostic Imagine

Bydgoszcz, 85-094

Poland

Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk, 80-952

Poland

Medical University Lublin, Diagnostic Imaging Department

Lublin,

Poland

Yonsei University Gangnam Severance Hospital

Seoul, Gangnam-gu 06273

South Korea

Seoul National University Hospital

Seoul, Jongno-gu 03080

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 16499

South Korea

Diagnòstic per la Imatge

Barcelona, 08025

Spain

Hospital Clínico San Cecilio

Granada, 18007

Spain

Hospital Nuestra, Resonancia Magnetica NTRA

Madrid, 28006

Spain