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

NCT ID: NCT07348640

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-02
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Steno-occlusive Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

AB

Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg

Group Type: EXPERIMENTAL

gadopiclenol

Intervention Type: DRUG

Gadopiclenol enhanced-Magnetic Resonance Angiography

Gadoterate meglumine (Dotarem)

Intervention Type: DRUG

Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

BA

Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol

Group Type: ACTIVE_COMPARATOR

gadopiclenol

Intervention Type: DRUG

Gadopiclenol enhanced-Magnetic Resonance Angiography

Gadoterate meglumine (Dotarem)

Intervention Type: DRUG

Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Interventions

gadopiclenol

Gadopiclenol enhanced-Magnetic Resonance Angiography

Intervention Type: DRUG

Gadoterate meglumine (Dotarem)

Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bracco Imaging S.p.A.

INDUSTRY

Sponsor Role: collaborator

Guerbet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Hôpital Cardiovasculaire et Pneumologique

Bron, , France

CHU Dijon Bourgogne

Dijon, , France

CHU de Poitiers

Poitiers, , France

Charité - Universitätsmedizin Berlin

Berlin, , Germany

University Hospital Bonn

Bonn, , Germany

UH Essen

Essen, , Germany

University Hospital of Saarland

Homburg, , Germany

Klinik fuer Diagnostische Radiologie and Neuroradiologie

Kiel, , Germany

Department of Neuroradiology, UKSH Campus Lübeck

Lübeck, , Germany

LMU University Hospital

München, , Germany

Semmelweis University - Budapest

Budapest, , Hungary

University of Debrecen - Debrecen

Debrecen, , Hungary

University of Pecs Clinical Centre

Pécs, , Hungary

Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII

Bergamo, , Italy

Azienda Ospedaliera di Monserrato

Cagliari, , Italy

ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara

Chieti, , Italy

Department of Diagnostic Imaging, Humanitas Research Hospital

Milan, , Italy

Diagnostica per Immagini e Interventistica Ospedale Umberto I

Roma, , Italy

Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome

Roma, , Italy

Ospedale Ca' Foncello

Treviso, , Italy

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

Bydgoszcz, , Poland

Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk, , Poland

Medical University Lublin, Diagnostic Imaging Department

Lublin, , Poland

Yonsei University Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Seoul St. Mary's Hospital

Seoul, Seocho-gu, South Korea

Asan Medical Center

Seoul, Songpa-gu, South Korea

Ajou University Hospital

Gyeonggi-do, Suwon-si, South Korea

Diagnòstic per la Imatge

Barcelona, , Spain

Hospital Clínico San Cecilio

Granada, , Spain

Hospital Nuestra, Resonancia Magnetica NTRA

Madrid, , Spain

Countries

United States; Canada; Czechia; France; Germany; Hungary; Italy; Poland; South Korea; Spain

Central Contacts

Sophie Rollin, PhD

Role: CONTACT

sophie.rollin@guerbet.com

+33688196716

Frantz Hébert, MSc

Role: CONTACT

frantz.hebert@guerbet.com

Facility Contacts

Arash Bedayat, MD

Role: primary

abedayat@mednet.ucla.edu

310-267-8708

David Zander, MD

Role: primary

david.zander@cuanschutz.edu

303-579-1597

Robert Edelman, MD

Role: primary

REdelman@northshore.org

847-570-2098

Jeremy Collins, MD

Role: primary

Collins.Jeremy@mayo.edu

507-293-1681

Dipan Shah, MD

Role: primary

djshah@houstonmethodist.org

713-441-1308

Majid Chalian, MD

Role: primary

mchalian@uw.edu

206-598-6868

Gilles Soulez, MD

Role: primary

Marek Mechl, MD

Role: primary

Lukáš Lambert Miksik, MD

Role: primary

Thomas Tourdias, MD

Role: primary

Philippe Douek, MD

Role: primary

Romaric Loffroy, MD

Role: primary

Rémy Guillevin, MD

Role: primary

Dominik Giesel, MD

Role: primary

Alexander Isaak, MD

Role: primary

Benedikt Schaarschmidt, MD

Role: primary

Gunter Schneider, MD

Role: primary

Sönke Peters, MD

Role: primary

Peter Schramm, MD

Role: primary

Sophia Stöcklein, MD

Role: primary

Bela Merkely, MD

Role: primary

Oláh László, MD

Role: primary

Attila Schwarcz, MD

Role: primary

Simonetta Gerevini, MD

Role: primary

Luca Saba, MD

Role: primary

Massimo Caulo, MD

Role: primary

Andrea Laghi, MD

Role: primary

Carlo Catalano, MD

Role: primary

Luigi Natale, MD

Role: primary

Giovanni Morana, MD

Role: primary

Zbigniew Serafin, MD

Role: primary

Katarzyna Dziadziuszko, MD

Role: primary

Radoslaw Pietura, MD

Role: primary

Sang Hyun Suh, MD

Role: primary

Whal Lee, MD

Role: primary

Joon Yong Jung, MD

Role: primary

Ho-Sung Kim, MD

Role: primary

Jin Wook Choi, MD

Role: primary

Josep Munuera, MD

Role: primary

Jose Luis Martín Rodríguez, MD

Role: primary

Eliseo Vañó Galván, MD

Role: primary

Other Identifiers

2024-518835-13-00

Identifier Type: CTIS

Identifier Source: secondary_id

GDX-102 - GDX-44-017

Identifier Type: -

Identifier Source: org_study_id