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
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
Sex
ALL
Min age
18 Years
Max age
—
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, 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.
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 (41)
Facility
City
Region
Status
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
Not Yet Recruiting
Mayo Clinic
Rochester
Minnesota
Not Yet Recruiting
Houston Methodist Hospital
Houston
Texas
Not Yet Recruiting
University of Washington
Seattle
Washington
Not Yet Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal
Quebec
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
Not Yet Recruiting
Hôpital Cardiovasculaire et Pneumologique
Bron
France
Not Yet Recruiting
CHU Dijon Bourgogne
Dijon
France
Not Yet 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
UH Essen
Essen
Germany
Not Yet Recruiting
University Hospital of Saarland
Homburg
Germany
Not Yet Recruiting
Klinik fuer Diagnostische Radiologie and Neuroradiologie
Kiel
Germany
Not Yet Recruiting
Department of Neuroradiology, UKSH Campus Lübeck
Lübeck
Germany
Not Yet Recruiting
LMU University Hospital
München
Germany
Not Yet Recruiting
Semmelweis University - Budapest
Budapest
Hungary
Not Yet Recruiting
University of Debrecen - Debrecen
Debrecen
Hungary
Recruiting
University of Pecs Clinical Centre
Pécs
Hungary
Recruiting
Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII
Bergamo
Italy
Not Yet Recruiting
Azienda Ospedaliera di Monserrato
Cagliari
Italy
Not Yet Recruiting
ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara
Chieti
Italy
Not Yet Recruiting
Department of Diagnostic Imaging, Humanitas Research Hospital
Milan
Italy
Not Yet Recruiting
Diagnostica per Immagini e Interventistica Ospedale Umberto I
Roma
Italy
Not Yet Recruiting
Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome
Roma
Italy
Not Yet Recruiting
Ospedale Ca' Foncello
Treviso
Italy
Not Yet 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
Diagnòstic per la Imatge
Barcelona
Spain
Not Yet Recruiting
Hospital Clínico San Cecilio
Granada
Spain
Not Yet Recruiting
+ 1 more sites — see the full list on the official registry below.
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.
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