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Evaluating Gadopiclenol for Vascular Disease Imaging

This study is looking at how well a new contrast agent, gadopiclenol, works compared to a commonly used one, Gadoterate meglumine (Dotarem), during Magnetic Resonance Angiography (MRA). MRA is a special type of MRI scan that helps doctors see blood vessels. We are studying adults who are suspected of having steno-occlusive disease, which means their blood vessels might be narrowed or blocked. The main goal is to see if gadopiclenol is just as good as Gadoterate meglumine in helping doctors diagnose and evaluate these vascular diseases. We plan to enroll 315 patients, and the study is currently unclear on its recruitment status. To join, you must be 18 years or older and willing to follow the study procedures.

Study design
This is an interventional study comparing two different contrast agents during MRA scans. It plans to enroll 315 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 30 days after the MRA scan.

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NCT07348640

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

Recruiting
PHASE3Ages 18+InterventionalDiagnostic
Guerbet
~315 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:gadopiclenolGadoterate meglumine (Dotarem)

At a glance

Recruiting sites
2 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Non-inferiority
Measured over 30 days

Conditions

Steno-occlusive Disease

Explore related trials

Venous Obstruction

Where it's being run

41 sites across 19 states
Germany7
Italy7
France4
Hungary3
Poland3
Spain3
Czechia2
California1

Who to contact

Sophie Rollin, PhD
[email protected]
+33688196716
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Non-inferiority30 days

    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.