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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 | Clinical Trials | Clareo Health

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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 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

NCT07348640•Guerbet

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (41)

University of California Los Angeles (UCLA)

Los Angeles, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Northshore - Evanston Hospital

Evanston, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

Houston Methodist Hospital

Houston, Texas, United States

University of Washington

Seattle, Washington, United States

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Department of Radiology and Nuclear Medicine, University Hospital Brno

Brno, Czechia

Motol University Hospital

Prague, Czechia

CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, France

Key Dates

Start Date

February 2, 2026

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

January 20, 2026

Enrollment

315

ESTIMATED participants

Conditions

Steno-occlusive Disease

Interventions

gadopiclenol

DRUG

Gadoterate meglumine (Dotarem)

DRUG

Contacts

Sophie Rollin, PhD

CONTACT

+33688196716 sophie.rollin@guerbet.com

Frantz Hébert, MSc

CONTACT

frantz.hebert@guerbet.com