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

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

Overview

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.

Interventions

• Drug gadopiclenol
  Gadopiclenol enhanced-Magnetic Resonance Angiography
• Drug Gadoterate meglumine (Dotarem)
  Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Primary outcome measures

• Non-inferiority [Time frame: 30 days]

Secondary outcome measures (1)

• Adverse Events [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

• 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.
• 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.
• Patient with suspected steno-occlusive disease in supra-aortic (carotid/vertebrobasilar) (a), peripheral (b) or abdominal/renal (c) arteries based on:

• 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
• 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
• 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)

• 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

• 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.
• Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.
• 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.
• 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
• 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.
• 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.
• Has any contraindications to MRI.
• Is suffering from severe claustrophobia.
• 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.
• Was previously included in this trial.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Diagnostic

Study locations

Germany · 7 centers

• Charité - Universitätsmedizin Berlin — Berlin
• University Hospital Bonn — Bonn
• UH Essen — Essen
• University Hospital of Saarland — Homburg
• Klinik fuer Diagnostische Radiologie and Neuroradiologie — Kiel
• Department of Neuroradiology, UKSH Campus Lübeck — Lübeck
• LMU University Hospital — München

Italy · 7 centers

• Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII — Bergamo
• Azienda Ospedaliera di Monserrato — Cagliari
• ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescar — Chieti
• Department of Diagnostic Imaging, Humanitas Research Hospital — Milan
• Diagnostica per Immagini e Interventistica Ospedale Umberto I — Roma
• Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnosti — Roma
• Ospedale Ca' Foncello — Treviso

United States · 6 centers

• University of California Los Angeles (UCLA) — Los Angeles
• UCHealth University of Colorado Hospital — Aurora
• Northshore - Evanston Hospital — Evanston
• Mayo Clinic — Rochester
• Houston Methodist Hospital — Houston
• University of Washington — Seattle

South Korea · 5 centers

• Yonsei University Gangnam Severance Hospital — Seoul
• Seoul National University Hospital — Seoul
• Seoul St. Mary's Hospital — Seoul
• Asan Medical Center — Seoul
• Ajou University Hospital — Gyeonggi-do

France · 4 centers

• CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux
• Hôpital Cardiovasculaire et Pneumologique — Bron
• CHU Dijon Bourgogne — Dijon
• CHU de Poitiers — Poitiers

Hungary · 3 centers

• Semmelweis University - Budapest — Budapest
• University of Debrecen - Debrecen — Debrecen
• University of Pecs Clinical Centre — Pécs

Poland · 3 centers

• University Hospital No.1, Department of Radiology and Diagnostic Imagine — Bydgoszcz
• Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku — Gdansk
• Medical University Lublin, Diagnostic Imaging Department — Lublin

Spain · 3 centers

• Diagnòstic per la Imatge — Barcelona
• Hospital Clínico San Cecilio — Granada
• Hospital Nuestra, Resonancia Magnetica NTRA — Madrid

Czechia · 2 centers

• Department of Radiology and Nuclear Medicine, University Hospital Brno — Brno
• Motol University Hospital — Prague

Canada · 1 center

• Centre Hospitalier de l'Université de Montréal — Montreal

Identifiers

NCT: NCT07348640 · GDX-102 - GDX-44-017 · 2024-518835-13-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗