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

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

Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI

Study Overview

• Status: Not yet recruiting
• Conditions: Steno-occlusive Disease
• Intervention / Treatment: Drug: gadopiclenol; Drug: Gadoterate meglumine (Dotarem)

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.

• Study Type: Interventional
• Enrollment (Estimated): 315
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sophie Rollin, PhD; Phone Number: +33688196716; Email: sophie.rollin@guerbet.com
• Study Contact Backup: Name: Frantz Hébert, MSc; Email: frantz.hebert@guerbet.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2X 3J2
      • Centre Hospitalier de l'Université de Montréal
      • Contact: Gilles Soulez, MD
• Czechia
  • Brno, Czechia, 625 00
    • Department of Radiology and Nuclear Medicine, University Hospital Brno
    • Contact: Marek Mechl, MD
  • Prague, Czechia, 150 06
    • Motol University Hospital
    • Contact: Lukáš Lambert Miksik, MD
• France
  • Bordeaux, France, 33076
    • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
    • Contact: Thomas Tourdias, MD
  • Bron, France, 69500
    • Hôpital Cardiovasculaire et Pneumologique
    • Contact: Philippe Douek, MD
  • Dijon, France, 21079
    • Chu Dijon Bourgogne
    • Contact: Romaric Loffroy, MD
  • Poitiers, France, 86000
    • Chu de Poitiers
    • Contact: Rémy Guillevin, MD
• Germany
  • Berlin, Germany, 13353
    • Charité - Universitätsmedizin Berlin
    • Contact: Dominik Giesel, MD
  • Bonn, Germany
    • University Hospital Bonn
    • Contact: Alexander Isaak, MD
  • Essen, Germany, 45147
    • UH Essen
    • Contact: Benedikt Schaarschmidt, MD
  • Homburg, Germany, 66421
    • UniversitY Hospital of Saarland
    • Contact: Gunter Schneider, MD
  • Kiel, Germany, D-24105
    • Klinik fuer Diagnostische Radiologie and Neuroradiologie
    • Contact: Sönke Peters, MD
  • Lübeck, Germany, 23538
    • Department of Neuroradiology, UKSH Campus Lübeck
    • Contact: Peter Schramm, MD
  • München, Germany, 81377
    • LMU University Hospital
    • Contact: Sophia Stöcklein, MD
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University - Budapest
    • Contact: Bela Merkely, MD
  • Debrecen, Hungary
    • University of Debrecen - Debrecen
    • Contact: Oláh László, MD
  • Pécs, Hungary, 7623
    • University of Pecs Clinical Centre
    • Contact: Attila Schwarcz, MD
• Italy
  • Bergamo, Italy, 34127
    • Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII
    • Contact: Simonetta Gerevini, MD
  • Cagliari, Italy, 09124
    • Azienda Ospedaliera di Monserrato
    • Contact: Luca Saba, MD
  • Chieti, Italy
    • ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara
    • Contact: Massimo Caulo, MD
  • Milan, Italy, 20089
    • Department of Diagnostic Imaging, Humanitas Research Hospital
    • Contact: Andrea Laghi, MD
  • Roma, Italy, 00161
    • Diagnostica per Immagini e Interventistica Ospedale Umberto I
    • Contact: Carlo Catalano, MD
  • Roma, Italy, 00168
    • Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome
    • Contact: Luigi Natale, MD
  • Treviso, Italy, 31100
    • Ospedale Ca' Foncello
    • Contact: Giovanni Morana, MD
• Poland
  • Bydgoszcz, Poland, 85-094
    • University Hospital No.1, Department of Radiology and Diagnostic Imagine
    • Contact: Zbigniew Serafin, MD
  • Gdansk, Poland, 80-952
    • Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku
    • Contact: Katarzyna Dziadziuszko, MD
  • Lublin, Poland
    • Medical University Lublin, Diagnostic Imaging Department
    • Contact: Radoslaw Pietura, MD
• South Korea
  • Gangnam-gu
    • Seoul, Gangnam-gu, South Korea, 06273
      • Yonsei University Gangnam Severance Hospital
      • Contact: Sang Hyun Suh, MD
  • Jongno-gu
    • Seoul, Jongno-gu, South Korea, 03080
      • Seoul National University Hospital
      • Contact: Whal Lee, MD
  • Seocho-gu
    • Seoul, Seocho-gu, South Korea
      • Seoul St. Mary'S Hospital
      • Contact: Joon Yong Jung, MD
  • Songpa-gu
    • Seoul, Songpa-gu, South Korea
      • Asan Medical Center
      • Contact: Ho-Sung Kim, MD
  • Suwon-si
    • Gyeonggi-do, Suwon-si, South Korea, 16499
      • Ajou University Hospital
      • Contact: Jin Wook Choi, MD
• Spain
  • Barcelona, Spain, 08025
    • Diagnòstic per la Imatge
    • Contact: Josep Munuera, MD
  • Granada, Spain, 18007
    • Hospital Clínico San Cecilio
    • Contact: Jose Luis Martín Rodríguez, MD
  • Madrid, Spain, 28006
    • Hospital Nuestra, Resonancia Magnetica NTRA
    • Contact: Eliseo Vañó Galván, MD
• United States
  • California
    • Los Angeles, California, United States, 90095-7206
      • University of California Los Angeles (UCLA)
      • Contact: Arash Bedayat, MD; Phone Number: 310-267-8708; Email: abedayat@mednet.ucla.edu
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital
      • Contact: David Zander, MD; Phone Number: 303-579-1597; Email: david.zander@cuanschutz.edu
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Northshore - Evanston Hospital
      • Contact: Robert Edelman, MD; Phone Number: 847-570-2098; Email: REdelman@northshore.org
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic
      • Contact: Jeremy Collins, MD; Phone Number: 507-293-1681; Email: Collins.Jeremy@mayo.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
      • Contact: Dipan Shah, MD; Phone Number: 713-441-1308; Email: djshah@houstonmethodist.org
  • Washington
    • Seattle, Washington, United States, 98185
      • University of Washington
      • Contact: Majid Chalian, MD; Phone Number: 206-598-6868; Email: mchalian@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AB; Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg	Drug: gadopiclenol; Gadopiclenol enhanced-Magnetic Resonance Angiography; Drug: Gadoterate meglumine (Dotarem); Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography
Active Comparator: BA; Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol	Drug: gadopiclenol; Gadopiclenol enhanced-Magnetic Resonance Angiography; Drug: Gadoterate meglumine (Dotarem); Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	To assess the safety profile of gadopiclenol and gadoterate meglumine 0.1 mmol/kg in terms of incidence of adverse events and changes in vital signs.	30 days

Collaborators and Investigators

• Sponsor: Guerbet
• Collaborators: Bracco Imaging S.p.A.

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 15, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Estimated): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: steno-occlusive disease; gadopiclenol; Magnetic Resonnance Angiography
• Additional Relevant MeSH Terms: gadopiclenol; gadoterate meglumine
• Other Study ID Numbers: GDX-102 - GDX-44-017; 2024-518835-13-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No