Efficacy and safety of gadopiclenol versus gadoteric acid‑enhanced MRA in adult patients with suspected vascular disease

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What is this study about?

The study looks at adults who may have narrowing (called steno-occlusive disease) in the major arteries that supply the head, neck, arms, legs, abdomen, or kidneys, such as the carotid and vertebrobasilar vessels, other peripheral arteries, and abdominal/renal arteries. Two contrast agents are being compared: the new agent gadopiclenol and the established agent gadoterate meglumine. Both are given by a quick intravenous injection during a scan called Magnetic Resonance Angiography, which uses magnetic fields to create detailed pictures of blood vessels.

The purpose of the study is to show that the new agent works at least as well as the standard agent in finding and ruling out disease, measured by how often it correctly identifies problems (sensitivity) and how often it correctly shows no problem (specificity) when compared with reference tests such as Computed Tomography Angiography or Intra-arterial Digital Subtraction Angiography. Participants will receive one of the agents in a randomized, double‑blind, crossover design, meaning they will have two scanning sessions, each with a different agent, while neither the participants nor the doctors know which is used at each visit. The study follows a set schedule of visits and scans, and safety checks are performed after each injection.

1 first mra visit

intravenous bolus of the assigned contrast agent is given at the start of the visit. the dose is calculated by body weight: gadopiclenol 0.05 mmol per kilogram or gadoterate meglumine 0.1 mmol per kilogram.

the patient undergoes a magnetic resonance angiography (mra) scan immediately after the injection.

after the scan, a short observation period of about thirty minutes is performed to monitor for any immediate reactions.

2 washout period

a defined interval is required between the two mra visits to allow the contrast material to clear from the body. the exact length of this interval follows the study protocol and is communicated to the patient before the second visit.

3 second mra visit (crossover)

intravenous bolus of the alternate contrast agent is administered at the same weight‑based dose: the patient who received gadopiclenol first will now receive gadoterate meglumine 0.1 mmol/kg, and vice versa.

the patient undergoes a second magnetic resonance angiography (mra) scan using the new contrast agent.

a post‑scan observation of approximately thirty minutes is again carried out to ensure safety.

4 final safety follow‑up

the patient is asked to report any symptoms that appear in the days following each visit, typically within twenty‑four to forty‑eight hours.

if required by the study, additional reference imaging such as computed tomography angiography (cta) or intra‑arterial digital subtraction angiography (ia‑dsa) may be performed, but these procedures do not involve further study medication.

Who Can Join the Study?

  • Be 18 years of age or older, any gender, and be willing to take part in the study and follow all study steps.
  • Read the information in the informed consent form and sign it before any study procedure is done.
  • Have doctors suspect a narrowing or blockage (steno‑occlusive disease) in one of the following artery groups:
    • Arteries that supply the brain (supra‑aortic arteries, which include the carotid and vertebrobasilar arteries).
    • Arteries in the arms, legs, or other parts of the body (peripheral arteries).
    • Arteries that go to the abdomen and kidneys (abdominal/renal arteries).

    The suspicion must be based on at least one of these:

    • Having had a stroke, a brief brain attack called a transient ischemic attack (TIA), or a temporary loss of vision in one eye known as amaurosis fugax, or previous imaging tests such as CTA (Computed Tomography Angiography), IA‑DSA (Intra‑arterial Digital Subtraction Angiography), or ultrasound showing an abnormality.
    • Having symptoms of leg artery disease (pain or trouble walking) that are classified as stage II‑IV on the Leriche‑Fontaine scale or 1‑6 on the Rutherford scale, or imaging (Doppler ultrasound, CTA, MRA, or IA‑DSA) confirming the problem.
    • Being suspected of having high blood pressure caused by kidney artery problems (renovascular hypertension) that meets any of these:
      • Blood pressure does not improve with usual medicines (hypertension refractory to standard therapy).
      • Sudden worsening of previously known high blood pressure.
      • Sudden onset of moderate to severe high blood pressure before age 35, suggesting a condition called fibromuscular dysplasia.
      • Kidney function is getting worse, shown by a blood test called creatinine higher than 2 mg/dL, without another clear cause.
      • Abnormal or unclear results on a kidney Doppler ultrasound.
  • Be scheduled for, or already have had, a CTA or IA‑DSA scan that includes the relevant arteries (brain‑supra‑aortic, peripheral, or abdominal/renal) as required by the study.

Who Cannot Join the Study?

  • Pregnant or breastfeeding: If you are currently pregnant or nursing a baby, you cannot join. Women who could become pregnant are screened with a pregnancy test, asked about surgery that prevents pregnancy (like tubal ligation or hysterectomy), or confirmed to be post‑menopausal for at least one year.
  • You have already taken part in this trial before.
  • You have another health problem or situation that would make it difficult to collect reliable data, meet the study goals, or finish the required follow‑up visits.
  • You are allergic to any ingredient in the study medicines or have had a reaction to other gadolinium‑based contrast agents (GBCAs), which are special dyes used in imaging.
  • You have severe kidney disease, defined as an estimated glomerular filtration rate (eGFR) lower than 30 mL/min/1.73 m². eGFR is a test that estimates how well your kidneys are filtering waste.
  • You have acute kidney injury (AKI), shown by any of the following:
    • A rise in a blood test called serum creatinine by 0.3 mg/dL (about 26.5 µmol/L) within 48 hours, or
    • A rise in serum creatinine to 1.5 times your normal level within the past 7 days, or
    • Very low urine output (less than 0.5 mL per kilogram of body weight per hour for 6 hours).
  • You have received any contrast dye (used in MRI, CT, or DSA scans) before the first study drug dose, or you plan to receive such dye between the two MRI scans or after the second dose.
  • You have had, or are scheduled to have, any treatment for the blood vessel disease in the area being studied (such as endovascular therapy or vascular surgery) between the two MRI scans or between the MRI and the reference scan (CTA or IA‑DSA).
  • You have any condition that makes magnetic resonance imaging (MRI) unsafe, such as certain implanted metal devices.
  • You suffer from severe claustrophobia, which is an intense fear of being inside the narrow MRI scanner.
  • You have taken an experimental drug or used an experimental medical device before joining this study, or you plan to receive any experimental treatment during the trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Poitiers Poitiers France
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana Treviso Italy
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy Bydgoszcz Poland
University Of Debrecen Debrecen Hungary
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Brno Brno Czechia
Saarland University Hospital Homburg Germany
Semmelweis University Budapest Hungary
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
University Of Pecs Pecs Hungary
Centre Hospitalier Lyon Sud Pierre Benite France
Azienda Ospedaliera Universitaria Di Cagliari Monserrato Italy
Resonancia Magnética Nuestra Señora del Rosario Madrid Spain
Ufbunzhmoiraewtsocism Egcnc Ath Essen Germany
Fkugrzrd nopmfsnhk Mclwl a Hkeazjo Prague Czechia
Cwxyty Hzqhpsstgrp Uumlvmbnzidon Dh Disnz Dijon France
Kqglctzx dit Ulpfdhudajfg Mdqghggi Apy Munich Germany
Uctxvloqiczdaw Cgynxit Kexawlqxs Gdansk Poland
Hwnfruyk Dp Ls Syqkn Cimz I Sspy Pcr Barcelona Spain
Aygzqlq Oqlfwusrlya Pwgp Gladpkqs Xhgiu Bergamo Italy
Uwxzkwfyun Djdky Ssfpr De Rbfs Ll Sclimtvf Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
02.02.2026
France France
Not yet recruiting
02.02.2026
Germany Germany
Not yet recruiting
02.02.2026
Hungary Hungary
Recruiting
02.02.2026
Italy Italy
Not yet recruiting
02.02.2026
Poland Poland
Not yet recruiting
02.02.2026
Spain Spain
Recruiting
02.02.2026

Trial locations

Investigated drugs:

DOTAREM is a contrast agent that contains gadoteric acid. It is injected into a vein during an MRI scan to help doctors see blood vessels more clearly. In this study, DOTAREM is used as the standard or comparison product to evaluate how well the new contrast agent works.

GADOPICLENOL is a newer contrast agent that also contains gadolinium. It is given by injection right before a magnetic resonance angiography (MRA) exam. The trial is testing whether GADOPICLENOL can provide images that are at least as good as those obtained with DOTAREM for detecting narrowing or blockage in blood vessels.

Atherosclerotic arterial disease – This condition involves the buildup of fatty plaques within the walls of large and medium sized arteries, such as those supplying the brain, limbs, abdomen, and kidneys. Over time the plaques cause the artery to become narrower, limiting the amount of blood that can pass through. The reduced blood flow can develop gradually, often without obvious symptoms in the early stages. As the narrowing progresses, the affected area may experience intermittent discomfort, weakness, or reduced function during activity. If the plaque becomes unstable, it can partially block the artery, leading to more noticeable changes in blood supply.

Trial ID:
2024-518835-13-00
Protocol code:
GDX-102/GDX-44-017
Trial Phase:
Therapeutic confirmatory (Phase III)

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