Clinical trial Recruiting at 17 sites Phase 3 Interventional Ages 18 and up

Gadolinium MRI compare two contrast agents for artery disease in adults

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

Run by Guerbet · NCT07348640 · Data updated 2026-11-12

This study tests whether gadopiclenol can provide diagnostic images as good as gadoterate meglumine for adults with suspected steno-occlusive artery disease using MRI.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment315 (estimated)
SponsorGuerbet
Industry-sponsored
Locations43 sites (Birmingham, Alabama and 42 other locations)
StatusRecruiting
StartedJuly 28, 2026
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedOctober 7, 2026
Trial IDNCT07348640 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults 18 years or older with suspected steno-occlusive disease in supra-aortic, peripheral, or abdominal/renal arteries who can provide informed consent.

Probably not a fit

Patients whose imaging findings do not differ between the two agents or who do not have steno-occlusive disease may not experience a direct benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial comparing two MRI contrast agents, gadopiclenol and gadoterate meglumine, at a standard dose to diagnose vascular disease in the supra-aortic, peripheral, and abdominal/renal arteries. Participants with suspected steno-occlusive disease will undergo MRA with both agents to evaluate diagnostic performance. The study uses commercially available MRI scanners and standard MRA sequences to assess imaging outcomes. Safety and tolerability of gadopiclenol will also be monitored. Sites include major academic centers in Alabama, California, and Colorado, under a collaboration between Guerbet and Bracco Imaging.

Why it matters

Potential benefit: If gadopiclenol proves non-inferior or superior, patients could benefit from high-quality MR angiography with a compatible contrast agent.

How similar studies have gone: Previous imaging studies have shown comparative potential for different gadolinium agents in vascular MRI, but the direct head-to-head performance in this specific indication is being evaluated here.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Northshore - Evanston Hospital
    Evanston, Illinois, United States
    Recruiting
  • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
    Bordeaux, France
    Recruiting
  • Hôpital Cardiovasculaire et Pneumologique
    Bron, France
    Recruiting
  • CHU Dijon Bourgogne
    Dijon, France
    Recruiting
  • Klinik fuer Diagnostische Radiologie and Neuroradiologie
    Kiel, Germany
    Recruiting
  • Semmelweis University - Budapest
    Budapest, Hungary
    Recruiting
Show 37 more locations
  • 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
    Recruiting
  • Azienda Ospedaliera di Monserrato
    Cagliari, Italy
    Recruiting
  • ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara
    Chieti, Italy
    Recruiting
  • Diagnostica per Immagini e Interventistica Ospedale Umberto I
    Roma, Italy
    Recruiting
  • Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome
    Roma, Italy
    Recruiting
  • Ospedale Ca' Foncello
    Treviso, Italy
    Recruiting
  • Diagnòstic per la Imatge
    Barcelona, Spain
    Recruiting
  • Hospital Clínico San Cecilio
    Granada, Spain
    Recruiting
  • Hospital Nuestra, Resonancia Magnetica NTRA
    Madrid, Spain
    Recruiting
  • University of Alabama
    Birmingham, Alabama, United States
    Not yet recruiting
  • University of California Los Angeles (UCLA)
    Los Angeles, California, United States
    Not yet recruiting
  • UCHealth University of Colorado Hospital
    Aurora, Colorado, United States
    Not yet recruiting
  • Mayo Clinic
    Rochester, Minnesota, United States
    Not yet recruiting
  • University of Washington
    Seattle, Washington, United States
    Not yet recruiting
  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec, Canada
    Not yet recruiting
  • Seaman MRI research centre
    Calgary, Canada
    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 de Poitiers
    Poitiers, France
    Not yet recruiting
  • Charité - Universitätsmedizin Berlin
    Berlin, Germany
    Not yet recruiting
  • University Hospital Bonn
    Bonn, Germany
    Not yet recruiting
  • University of Bielefeld, Klinikum Lippe
    Detmold, Germany
    Not yet recruiting
  • UH Essen
    Essen, Germany
    Not yet recruiting
  • University Hospital of Saarland
    Homburg, Germany
    Not yet recruiting
  • Department of Neuroradiology, UKSH Campus Lübeck
    Lübeck, Germany
    Not yet recruiting
  • Albert Szent-Györgyi Medical Center
    Szeged, Hungary
    Not yet recruiting
  • Department of Diagnostic Imaging, Humanitas Research Hospital
    Milan, 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, South Korea
    Not yet recruiting
  • Seoul National University Hospital
    Seoul, Jongno-gu, South Korea
    Not yet recruiting
  • Seoul St. Mary's Hospital
    Seoul, Seocho-gu, South Korea
    Not yet recruiting
  • Asan Medical Center
    Seoul, Songpa-gu, South Korea
    Not yet recruiting
  • Ajou University Hospital
    Gyeonggi-do, Suwon-si, South Korea
    Not yet recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.