New MRI dye could spot dangerous artery blockages better

NCT ID NCT07348640

Diagnosis Sponsor: Guerbet Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether a new contrast agent called gadopiclenol works as well as the standard agent (Dotarem) for MRI scans to find blocked arteries in the neck, legs, or abdomen. About 315 adults with suspected vascular disease will receive both agents in random order and have their scans compared against a reference standard (CT or X-ray angiography). The goal is to see if gadopiclenol is non-inferior in accuracy and has a similar safety profile.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: gadopiclenol (contrast agent for MRI)
What this could lead to: If successful, this could provide a safer or more effective contrast agent for MRI scans to detect blocked arteries, improving diagnosis of vascular disease.
What could go wrong: This is a Phase 3 trial, but it only aims to show non-inferiority (not superiority) to an existing agent. The results may not lead to a major change in practice, and individual safety profiles may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 315 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease vascular occlusion disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Steno-occlusive disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

41 sites in 10 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Ajou University Hospital
NOT_YET_RECRUITING

Gyeonggi-do, Suwon-si, 16499, South Korea
Asan Medical Center
NOT_YET_RECRUITING

Seoul, Songpa-gu, South Korea
Azienda Ospedaliera di Monserrato
NOT_YET_RECRUITING

Cagliari, 09124, Italy
CHU Dijon Bourgogne
NOT_YET_RECRUITING

Dijon, 21079, France
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin
NOT_YET_RECRUITING

Bordeaux, 33076, France
CHU de Poitiers
NOT_YET_RECRUITING

Poitiers, 86000, France
Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome
NOT_YET_RECRUITING

Roma, 00168, Italy
Centre Hospitalier de l'Université de Montréal
NOT_YET_RECRUITING

Montreal, Quebec, H2X 3J2, Canada
Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING

Berlin, 13353, Germany
Department of Diagnostic Imaging, Humanitas Research Hospital
NOT_YET_RECRUITING

Milan, 20089, Italy
Department of Neuroradiology, UKSH Campus Lübeck
NOT_YET_RECRUITING

Lübeck, 23538, Germany
Department of Radiology and Nuclear Medicine, University Hospital Brno
NOT_YET_RECRUITING

Brno, 625 00, Czechia
Diagnostica per Immagini e Interventistica Ospedale Umberto I
NOT_YET_RECRUITING

Roma, 00161, Italy
Diagnòstic per la Imatge
NOT_YET_RECRUITING

Barcelona, 08025, Spain
Hospital Clínico San Cecilio
NOT_YET_RECRUITING

Granada, 18007, Spain
Hospital Nuestra, Resonancia Magnetica NTRA
NOT_YET_RECRUITING

Madrid, 28006, Spain
Houston Methodist Hospital
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
Hôpital Cardiovasculaire et Pneumologique
NOT_YET_RECRUITING

Bron, 69500, France
ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara
NOT_YET_RECRUITING

Chieti, Italy
Klinik fuer Diagnostische Radiologie and Neuroradiologie
NOT_YET_RECRUITING

Kiel, D-24105, Germany
LMU University Hospital
NOT_YET_RECRUITING

München, 81377, Germany
Mayo Clinic
NOT_YET_RECRUITING

Rochester, Minnesota, 55901, United States
Medical University Lublin, Diagnostic Imaging Department
NOT_YET_RECRUITING

Lublin, Poland
Motol University Hospital
NOT_YET_RECRUITING

Prague, 150 06, Czechia
Northshore - Evanston Hospital
NOT_YET_RECRUITING

Evanston, Illinois, 60201, United States
Ospedale Ca' Foncello
NOT_YET_RECRUITING

Treviso, 31100, Italy
Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku
NOT_YET_RECRUITING

Gdansk, 80-952, Poland
Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII
NOT_YET_RECRUITING

Bergamo, 34127, Italy
Semmelweis University - Budapest
NOT_YET_RECRUITING

Budapest, 1122, Hungary
Seoul National University Hospital
NOT_YET_RECRUITING

Seoul, Jongno-gu, 03080, South Korea
Seoul St. Mary's Hospital
NOT_YET_RECRUITING

Seoul, Seocho-gu, South Korea
UCHealth University of Colorado Hospital
NOT_YET_RECRUITING

Aurora, Colorado, 80045, United States
UH Essen
NOT_YET_RECRUITING

Essen, 45147, Germany
University Hospital Bonn
NOT_YET_RECRUITING

Bonn, Germany
University Hospital No.1, Department of Radiology and Diagnostic Imagine
NOT_YET_RECRUITING

Bydgoszcz, 85-094, Poland
University Hospital of Saarland
NOT_YET_RECRUITING

Homburg, 66421, Germany
University of California Los Angeles (UCLA)
NOT_YET_RECRUITING

Los Angeles, California, 90095-7206, United States
University of Debrecen - Debrecen
RECRUITING

Debrecen, Hungary
University of Pecs Clinical Centre
RECRUITING

Pécs, 7623, Hungary
University of Washington
NOT_YET_RECRUITING

Seattle, Washington, 98185, United States
Yonsei University Gangnam Severance Hospital
NOT_YET_RECRUITING

Seoul, Gangnam-gu, 06273, South Korea

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