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Steno-occlusive DiseasePhase 3NCT07348640

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 Phase 3 study testing gadopiclenol and Gadoterate meglumine (Dotarem) in people with Steno-occlusive Disease, run by Guerbet at 43 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Steno-occlusive Disease
What is being tested?
gadopiclenol and Gadoterate meglumine (Dotarem)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
43 sitesin 10 countries
Study dates
28 Jul 2026to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

43 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Sophie Rollin, PhD contact

+33688196716

sophie.rollin@guerbet.com

Frantz Hébert, MSc contact

frantz.hebert@guerbet.com

43 sites in 10 countries

Germany7 sites, 7 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353

    Dominik Giesel, MD

    Not yet recruiting

  • University Hospital Bonn

    Bonn

    Alexander Isaak, MD

    Not yet recruiting

  • University of Bielefeld, Klinikum Lippe

    Detmold, 32756

    Michel Eisenblätter, MD

    Not yet recruiting

  • UH Essen

    Essen, 45147

    Yan Li, MD

    Not yet recruiting

  • University Hospital of Saarland

    Homburg, 66421

    Gunter Schneider, MD

    Not yet recruiting

  • Klinik fuer Diagnostische Radiologie and Neuroradiologie

    Kiel, D-24105

    Sönke Peters, MD

    Recruiting

  • Department of Neuroradiology, UKSH Campus Lübeck

    Lübeck, 23538

    Peter Schramm, MD

    Not yet recruiting

Other trials in Germany

Italy7 sites, 7 recruiting

  • Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII

    Bergamo, 34127

    Simonetta Gerevini, MD

    Recruiting

  • Azienda Ospedaliera di Monserrato

    Cagliari, 09124

    Luca Saba, MD

    Recruiting

  • ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara

    Chieti

    Massimo Caulo, MD

    Recruiting

  • Department of Diagnostic Imaging, Humanitas Research Hospital

    Milan, 20089

    Andrea Laghi, MD

    Not yet recruiting

  • Diagnostica per Immagini e Interventistica Ospedale Umberto I

    Roma, 00161

    Carlo Catalano, MD

    Recruiting

  • Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome

    Roma, 00168

    Luigi Natale, MD

    Recruiting

  • Ospedale Ca' Foncello

    Treviso, 31100

    Giovanni Morana, MD

    Recruiting

Other trials in Italy

United States6 sites, 6 recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    David Zander, MD

    Not yet recruiting

  • University of Alabama

    Birmingham, Alabama, 35233

    Manoj Tanwar, MD

    Not yet recruiting

  • Northshore - Evanston Hospital

    Evanston, Illinois, 60201

    Robert Edelman, MD

    Recruiting

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095-7206

    Arash Bedayat, MD

    Not yet recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55901

    Jeremy Collins, MD

    Not yet recruiting

  • University of Washington

    Seattle, Washington, 98185

    Majid Chalian, MD

    Not yet recruiting

Other trials in United States

South Korea5 sites, 5 recruiting

  • Ajou University Hospital

    Gyeonggi-do, Suwon-si, 16499

    Jin Wook Choi, MD

    Not yet recruiting

  • Yonsei University Gangnam Severance Hospital

    Seoul, Gangnam-gu, 06273

    Sang Hyun Suh, MD

    Not yet recruiting

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

    Whal Lee, MD

    Not yet recruiting

  • Seoul St. Mary's Hospital

    Seoul, Seocho-gu

    Joon Yong Jung, MD

    Not yet recruiting

  • Asan Medical Center

    Seoul, Songpa-gu

    Ho-Sung Kim, MD

    Not yet recruiting

Other trials in South Korea

France4 sites, 4 recruiting

  • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076

    Thomas Tourdias, MD

    Recruiting

  • Hôpital Cardiovasculaire et Pneumologique

    Bron, 69500

    Philippe Douek, MD

    Recruiting

  • CHU Dijon Bourgogne

    Dijon, 21079

    Romaric Loffroy, MD

    Recruiting

  • CHU de Poitiers

    Poitiers, 86000

    Rémy Guillevin, MD

    Not yet recruiting

Other trials in France

Hungary4 sites, 4 recruiting

  • Semmelweis University - Budapest

    Budapest, 1122

    Bela Merkely, MD

    Recruiting

  • University of Debrecen - Debrecen

    Debrecen

    Oláh László, MD

    Recruiting

  • University of Pecs Clinical Centre

    Pécs, 7623

    Attila Schwarcz, MD

    Recruiting

  • Albert Szent-Györgyi Medical Center

    Szeged, 6725

    Zsigmond Kincses, MD

    Not yet recruiting

Other trials in Hungary

Poland3 sites, 3 recruiting

  • University Hospital No.1, Department of Radiology and Diagnostic Imagine

    Bydgoszcz, 85-094

    Zbigniew Serafin, MD

    Not yet recruiting

  • Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku

    Gdansk, 80-952

    Katarzyna Dziadziuszko, MD

    Not yet recruiting

  • Medical University Lublin, Diagnostic Imaging Department

    Lublin

    Radoslaw Pietura, MD

    Not yet recruiting

Other trials in Poland

Spain3 sites, 3 recruiting

  • Diagnòstic per la Imatge

    Barcelona, 08025

    Josep Munuera, MD

    Recruiting

  • Hospital Clínico San Cecilio

    Granada, 18007

    Jose Luis Martín Rodríguez, MD

    Recruiting

  • Hospital Nuestra, Resonancia Magnetica NTRA

    Madrid, 28006

    Eliseo Vañó Galván, MD

    Recruiting

Other trials in Spain

Canada2 sites, 2 recruiting

  • Seaman MRI research centre

    Calgary

    Johanna Ospel, MD

    Not yet recruiting

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 3J2

    Gilles Soulez, MD

    Not yet recruiting

Other trials in Canada

Czechia2 sites, 2 recruiting

  • Department of Radiology and Nuclear Medicine, University Hospital Brno

    Brno, 625 00

    Marek Mechl, MD

    Not yet recruiting

  • Motol University Hospital

    Prague, 150 06

    Lukáš Lambert Miksik, MD

    Not yet recruiting

Other trials in Czechia

About this study

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

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

Read the 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.

Being tested
gadopiclenol, Gadoterate meglumine (Dotarem)
Keywords
steno-occlusive disease, gadopiclenol, Magnetic Resonnance Angiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gadopiclenolDrug

    Gadopiclenol enhanced-Magnetic Resonance Angiography

  • Gadoterate meglumine (Dotarem)Drug

    Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Study groups in NCT07348640
Study groupRoleWhat they receive
ABExperimentalGadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg
Receives: Drug: gadopiclenol; Drug: Gadoterate meglumine (Dotarem)
BAActive comparatorGadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol
Receives: Drug: gadopiclenol; Drug: Gadoterate meglumine (Dotarem)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 30 days

Secondary outcomes (1)

  1. 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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start28 Jul 2026
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
315 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07348640
Sponsor's protocol ID
GDX-102 - GDX-44-017
Other IDs
2024-518835-13-00
Status last verified
Oct 2026
First submitted
15 Jan 2026
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gadopiclenol and Gadoterate meglumine (Dotarem) in people with Steno-occlusive Disease, run by Guerbet at 43 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Germany, Italy, United States, South Korea, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sophie Rollin, PhD (+33688196716, sophie.rollin@guerbet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-inferiority (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07348640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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