Semmelweis University
Budapest, Hungary
Recruiting
Efficacy and safety of gadopiclenol versus gadoteric acid‑enhanced MRA in adult patients with suspected vascular disease
Fast replyRegistered drug
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
13 criteria
- 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).
- 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 trial?
13 criteria
- 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.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Responsive Responsive Universita Degli Studi Di Roma La Sapienza
Rome, ItalyResponsive Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate
Chieti, Italy
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
RecruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
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.
What is already known about the treatment
DOTAREM
This medication is given as a fast intravenous (IV) injection and is used as a contrast agent to improve the pictures taken during MRI scans of blood vessels. It is an approved, widely used drug that helps doctors see the arteries and veins more clearly. It works by a small amount of gadolinium that changes how water in the body responds to the magnetic field, making the vessels appear brighter on the images. It belongs to the class of gadolinium‑based, paramagnetic contrast agents for magnetic resonance imaging.
GADOPICLENOL
This drug is also administered by a quick IV injection and is being tested as a contrast agent for MRI scans that look at blood vessels. It is still investigational and not yet widely approved, but early studies suggest it can give clear images at a lower dose. It contains gadolinium that enhances the magnetic signal of water, helping the scanned vessels stand out in the pictures. It is classified as a gadolinium‑based, macrocyclic contrast agent used in magnetic resonance imaging.
Investigated diseases
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518835-13-00Protocol codeGDX-102/GDX-44-017Estimated enrolment315 patients
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?