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

August 12, 2026 updated by: Guerbet

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

Recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J2
        • Not yet recruiting
        • Centre Hospitalier de l'Universite de Montreal
        • Contact:
          • Gilles Soulez, MD
  • Czechia
      • Brno, Czechia, 625 00
        • Not yet recruiting
        • Department of Radiology and Nuclear Medicine, University Hospital Brno
        • Contact:
          • Marek Mechl, MD
      • Prague, Czechia, 150 06
        • Not yet recruiting
        • Motol University Hospital
        • Contact:
          • Lukáš Lambert Miksik, MD
  • France
      • Bordeaux, France, 33076
        • Not yet recruiting
        • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
        • Contact:
          • Thomas Tourdias, MD
      • Bron, France, 69500
        • Not yet recruiting
        • Hôpital Cardiovasculaire et Pneumologique
        • Contact:
          • Philippe Douek, MD
      • Dijon, France, 21079
        • Not yet recruiting
        • CHU Dijon Bourgogne
        • Contact:
          • Romaric Loffroy, MD
      • Poitiers, France, 86000
        • Not yet recruiting
        • Chu de Poitiers
        • Contact:
          • Rémy Guillevin, MD
  • Germany
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Charité - Universitätsmedizin Berlin
        • Contact:
          • Dominik Giesel, MD
      • Bonn, Germany
        • Not yet recruiting
        • University Hospital Bonn
        • Contact:
          • Alexander Isaak, MD
      • Essen, Germany, 45147
        • Not yet recruiting
        • UH Essen
        • Contact:
          • Benedikt Schaarschmidt, MD
      • Homburg, Germany, 66421
        • Not yet recruiting
        • UniversitY Hospital of Saarland
        • Contact:
          • Gunter Schneider, MD
      • Kiel, Germany, D-24105
        • Not yet recruiting
        • Klinik fuer Diagnostische Radiologie and Neuroradiologie
        • Contact:
          • Sönke Peters, MD
      • Lübeck, Germany, 23538
        • Not yet recruiting
        • Department of Neuroradiology, UKSH Campus Lübeck
        • Contact:
          • Peter Schramm, MD
      • München, Germany, 81377
        • Not yet recruiting
        • LMU University Hospital
        • Contact:
          • Sophia Stöcklein, MD
  • Hungary
      • Budapest, Hungary, 1122
        • Not yet recruiting
        • Semmelweis University - Budapest
        • Contact:
          • Bela Merkely, MD
      • Debrecen, Hungary
        • Recruiting
        • University of Debrecen - Debrecen
        • Contact:
          • Oláh László, MD
      • Pécs, Hungary, 7623
        • Recruiting
        • University of Pecs Clinical Centre
        • Contact:
          • Attila Schwarcz, MD
  • Italy
      • Bergamo, Italy, 34127
        • Not yet recruiting
        • Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII
        • Contact:
          • Simonetta Gerevini, MD
      • Cagliari, Italy, 09124
        • Not yet recruiting
        • Azienda Ospedaliera di Monserrato
        • Contact:
          • Luca Saba, MD
      • Chieti, Italy
        • Not yet recruiting
        • ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara
        • Contact:
          • Massimo Caulo, MD
      • Milan, Italy, 20089
        • Not yet recruiting
        • Department of Diagnostic Imaging, Humanitas Research Hospital
        • Contact:
          • Andrea Laghi, MD
      • Roma, Italy, 00161
        • Not yet recruiting
        • Diagnostica per Immagini e Interventistica Ospedale Umberto I
        • Contact:
          • Carlo Catalano, MD
      • Roma, Italy, 00168
        • Not yet recruiting
        • Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome
        • Contact:
          • Luigi Natale, MD
      • Treviso, Italy, 31100
        • Not yet recruiting
        • Ospedale Ca' Foncello
        • Contact:
          • Giovanni Morana, MD
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Not yet recruiting
        • University Hospital No.1, Department of Radiology and Diagnostic Imagine
        • Contact:
          • Zbigniew Serafin, MD
      • Gdansk, Poland, 80-952
        • Not yet recruiting
        • Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku
        • Contact:
          • Katarzyna Dziadziuszko, MD
      • Lublin, Poland
        • Not yet recruiting
        • Medical University Lublin, Diagnostic Imaging Department
        • Contact:
          • Radoslaw Pietura, MD
  • South Korea
    • Gangnam-gu
      • Seoul, Gangnam-gu, South Korea, 06273
        • Not yet recruiting
        • Yonsei University Gangnam Severance Hospital
        • Contact:
          • Sang Hyun Suh, MD
    • Jongno-gu
      • Seoul, Jongno-gu, South Korea, 03080
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
          • Whal Lee, MD
    • Seocho-gu
      • Seoul, Seocho-gu, South Korea
        • Not yet recruiting
        • Seoul St. Mary's Hospital
        • Contact:
          • Joon Yong Jung, MD
    • Songpa-gu
      • Seoul, Songpa-gu, South Korea
        • Not yet recruiting
        • Asan Medical Center
        • Contact:
          • Ho-Sung Kim, MD
    • Suwon-si
      • Gyeonggi-do, Suwon-si, South Korea, 16499
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
          • Jin Wook Choi, MD
  • Spain
      • Barcelona, Spain, 08025
        • Not yet recruiting
        • Diagnòstic per la Imatge
        • Contact:
          • Josep Munuera, MD
      • Granada, Spain, 18007
        • Not yet recruiting
        • Hospital Clínico San Cecilio
        • Contact:
          • Jose Luis Martín Rodríguez, MD
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Hospital Nuestra, Resonancia Magnetica NTRA
        • Contact:
          • Eliseo Vañó Galván, MD
  • United States
    • California
      • Los Angeles, California, United States, 90095-7206
        • Not yet recruiting
        • University of California Los Angeles (UCLA)
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Not yet recruiting
        • Northshore - Evanston Hospital
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Not yet recruiting
        • Mayo Clinic
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
    • Washington
      • Seattle, Washington, United States, 98185
        • Not yet recruiting
        • University of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 30 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Collaborators

Bracco Imaging S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 28, 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 (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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