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

NCT07348640 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: GDX-102 - GDX-44-0172024-518835-13-00
• Study Type: interventional
• Target: 315
• Locations: 10 countries
• Sites: 41

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

Conditions

Steno-occlusive Disease

Keywords

steno-occlusive disease; gadopiclenol; Magnetic Resonnance Angiography

Outcome Measures

Primary Outcomes (1)

• Non-inferiority

  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.

  30 days

Secondary Outcomes (1)

• Adverse Events

  30 days

Study Arms (2)

AB

EXPERIMENTAL

Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg

Drug: gadopiclenol; Drug: Gadoterate meglumine (Dotarem)

BA

ACTIVE COMPARATOR

Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol

Drug: gadopiclenol; Drug: Gadoterate meglumine (Dotarem)

Interventions

gadopiclenol DRUG

Gadopiclenol enhanced-Magnetic Resonance Angiography

AB; BA

Gadoterate meglumine (Dotarem) DRUG

Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

AB; BA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patient with suspected steno-occlusive disease in supra-aortic (carotid/vertebrobasilar) (a), peripheral (b) or abdominal/renal (c) arteries based on:
• 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
• 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
• 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)
• 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.

You may not qualify if:

• 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.
• Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.
• 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.
• 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
• 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.
• 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.
• Has any contraindications to MRI.
• Is suffering from severe claustrophobia.
• 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.
• Was previously included in this trial.
• 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.

Sponsors & Collaborators

• Guerbet: lead
• Bracco Imaging S.p.A.: collaborator

Study Sites (41)

University of California Los Angeles (UCLA)

Los Angeles, California, 90095-7206, United States

Location

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Northshore - Evanston Hospital

Evanston, Illinois, 60201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98185, United States

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3J2, Canada

Location

Department of Radiology and Nuclear Medicine, University Hospital Brno

Brno, 625 00, Czechia

Location

Motol University Hospital

Prague, 150 06, Czechia

Location

CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Hôpital Cardiovasculaire et Pneumologique

Bron, 69500, France

Location

CHU Dijon Bourgogne

Dijon, 21079, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

UH Essen

Essen, 45147, Germany

Location

University Hospital of Saarland

Homburg, 66421, Germany

Location

Klinik fuer Diagnostische Radiologie and Neuroradiologie

Kiel, D-24105, Germany

Location

Department of Neuroradiology, UKSH Campus Lübeck

Lübeck, 23538, Germany

Location

LMU University Hospital

München, 81377, Germany

Location

Semmelweis University - Budapest

Budapest, 1122, Hungary

Location

University of Debrecen - Debrecen

Debrecen, Hungary

Location

University of Pecs Clinical Centre

Pécs, 7623, Hungary

Location

Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII

Bergamo, 34127, Italy

Location

Azienda Ospedaliera di Monserrato

Cagliari, 09124, Italy

Location

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

Chieti, Italy

Location

Department of Diagnostic Imaging, Humanitas Research Hospital

Milan, 20089, Italy

Location

Diagnostica per Immagini e Interventistica Ospedale Umberto I

Roma, 00161, Italy

Location

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

Roma, 00168, Italy

Location

Ospedale Ca' Foncello

Treviso, 31100, Italy

Location

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

Bydgoszcz, 85-094, Poland

Location

Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku

Gdansk, 80-952, Poland

Location

Medical University Lublin, Diagnostic Imaging Department

Lublin, Poland

Location

Yonsei University Gangnam Severance Hospital

Seoul, Gangnam-gu, 06273, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Seoul St. Mary's Hospital

Seoul, Seocho-gu, South Korea

Location

Asan Medical Center

Seoul, Songpa-gu, South Korea

Location

Ajou University Hospital

Gyeonggi-do, Suwon-si, 16499, South Korea

Location

Diagnòstic per la Imatge

Barcelona, 08025, Spain

Location

Hospital Clínico San Cecilio

Granada, 18007, Spain

Location

Hospital Nuestra, Resonancia Magnetica NTRA

Madrid, 28006, Spain

Location

MeSH Terms

Interventions

gadopiclenol; gadoterate meglumine

Central Study Contacts

Sophie Rollin, PhD

CONTACT

+33688196716; sophie.rollin@guerbet.com

Frantz Hébert, MSc

CONTACT

frantz.hebert@guerbet.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 16, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); PL (3); HU (3); ES (3); IT (7); US (6); FR (4); CA (1); KR (5); CZ (2)