Clinical trial • Phase III • Cardiology

GADOPICLENOL for Steno-occlusive vascular disease|Renovascular hypertension (suspected)

Phase III trial of GADOPICLENOL for Steno-occlusive vascular disease|Renovascular hypertension (suspected).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Steno-occlusive vascular disease|Renovascular hypertension (suspected)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
01-12-2025
First CTIS Authorization Date
15-04-2026

Trial design

Randomised, dotarem (gadoterate meglumine) 0.1 mmol/kg, solution for injection, intravenous bolus injection/iv infusion; study arms are crossover sequences: dgd-gdx (gadoterate meglumine then gadopiclenol) and gdx-dgd (gadopiclenol then gadoterate meglumine).-controlled, crossover Phase III trial across 29 sites in Czechia, France, Germany and others.

Randomised
Yes
Comparator
DOTAREM (gadoterate meglumine) 0.1 mmol/kg, solution for injection, intravenous bolus injection/IV infusion; study arms are crossover sequences: DGD-GDX (gadoterate meglumine then gadopiclenol) and GDX-DGD (gadopiclenol then gadoterate meglumine).
Crossover
Yes
Target Sample Size
300

Eligibility

Recruits 300 No vulnerable populations selected; only adults (18+). Participation requires written informed consent by the participant prior to any trial procedures (no assent procedures described)..

Pregnancy Exclusion
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.
Vulnerable Population
No vulnerable populations selected; only adults (18+). Participation requires written informed consent by the participant prior to any trial procedures (no assent procedures described).

Inclusion criteria

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

  • {"criterion_text":"- Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential: •\tby testing on site at the institution (serum βHCG or urine) (***) •\tby surgical history (e.g., tubal ligation or hysterectomy) •\tpost-menopausal with a minimum 1 year without menses.\n- Was previously included in this trial.\n- 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.\n- Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.\n- 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 (***).\n- 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\n- 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.\n- 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\n- Has any contraindications to MRI.\n- Is suffering from severe claustrophobia.\n- 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."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Diagnostic performance indicators, namely sensitivity and specificity for detecting clinically significant steno-occlusive disease of different vascular territories.","definition_or_measurement_approach":"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."}

Secondary endpoints

  • {"endpoint_text":"- To assess the safety profile of gadopiclenol X mmol/kg and gadoterate meglumine 0.1 mmol/kg in terms of incidence of adverse events and changes in vital signs.","definition_or_measurement_approach":"Incidence of adverse events and changes in vital signs monitored and recorded per protocol (safety assessments described as incidence of AEs and changes in vital signs)."}

Recruitment

Planned Sample Size
300
Recruitment Window Months
22
Consent Approach
Participants must read the information in the Informed Consent Form (ICF) and provide written consent by dating and signing the ICF prior to any trial-related procedure. Only adults (18+) are eligible. ICF/SIS documents are provided in multiple languages (documents available in English, Czech, French, German, Hungarian, Spanish, Polish, Italian as per submitted L1/L1_SIS and ICF documents).

Geography

Total Number Of Sites
29
Total Number Of Participants
300

Czechia

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
117
Number Of Sites
2
Number Of Participants
40

Sites

Site Name
Fakultni Nemocnice V Motole
Department Name
Klinika zobrazovacích metod ě. LF UK FN Motol
Contact Person Name
Lukáš Lambert
Contact Person Email
lukas.lambert@fnmotol.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Klinika radiologie a nukleární medicíny,
Contact Person Name
Marech Mechl
Contact Person Email
mechl.marek@fnbrno.cz

France

Earliest CTIS Part Ii Submission Date
26-03-2026
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
22
Number Of Sites
4
Number Of Participants
40

Sites

Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Radiology Department
Contact Person Name
Rémy Guillevin
Contact Person Email
remy.guillevin@chu-poitiers.fr
Site Name
Hospices Civils De Lyon
Department Name
Radiology Department
Contact Person Name
Phiippe Douek
Contact Person Email
philippe.douek@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
NeuroImaging Department
Contact Person Name
Thomas Tourdias
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Department of Radiology and Diagnostic and Therapeutic Medical Imaging
Contact Person Name
Romaric Loffroy
Contact Person Email
romaric.loffroy@chu-dijon.fr

Germany

Earliest CTIS Part Ii Submission Date
17-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
34
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Universitaetsklinikum Bonn AöR
Department Name
Klinik für Diagnostische und Interventionelle Radiologie
Contact Person Name
Alexander Isaak
Contact Person Email
alexander.isaak@ukbonn.de
Site Name
LMU Klinikum Muenchen AöR
Department Name
Klinik und Poliklinik fuer Radiologie
Contact Person Name
Sophia Stoecklein
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Kiel)
Department Name
Klinik für Diagnostische Radiologie and Neuroradiologie
Contact Person Name
Soenke Peters
Contact Person Email
Soenke.peters@uksh.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Klinik für Diagnostische und Interventionelle Radiologie
Contact Person Name
Guenther Schneider
Contact Person Email
dr.guenther.schneider@uks.eu
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Radiologie
Contact Person Name
Dominik Geisel
Contact Person Email
dominik.geisel@charite.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR (Luebeck)
Department Name
Institut für Neuroradiologie
Contact Person Name
Peter Schramm
Contact Person Email
peter.schramm@uksh.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Institute of Diagnostic and Interventional Radiology and Neuroradiology
Contact Person Name
Yan Li
Contact Person Email
Yan.li@uk-essen.de

Hungary

Earliest CTIS Part Ii Submission Date
10-02-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
69
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
University Of Pecs
Department Name
Neurosurgery
Contact Person Name
Attila Schwartz
Contact Person Email
schwarcz.attila@pte.hu
Site Name
University Of Debrecen
Department Name
Neurology
Contact Person Name
Laszlo Olah
Contact Person Email
olah@med.unideb.hu
Site Name
Semmelweis University
Department Name
Cardiology
Contact Person Name
Bela Merkely
Contact Person Email
merkely.study@gmail.com

Spain

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
122
Number Of Sites
3
Number Of Participants
40

Sites

Site Name
Resonancia Magnética Nuestra Señora del Rosario
Department Name
Radiology
Contact Person Name
Eliseo Vañó Galván
Contact Person Email
evano@rmrosario.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Radiology
Contact Person Name
Jose Luis Munuera del Cerro
Contact Person Email
jmunuera@santpau.cat
Site Name
Hospital Universitario Clinico San Cecilio
Department Name
Radiology
Contact Person Name
Jose Luis Martín Rodríguez
Contact Person Email
joseluismartin.rx@hotmail.com

Poland

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
42
Number Of Sites
3
Number Of Participants
50

Sites

Site Name
Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
Department Name
Zakład Radiologii i Diagnostyki Obrazowej
Contact Person Name
Zbigniew Serafin
Contact Person Email
zbigniew.serafin@pbs.edu.pl
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Zakład Radiologii/Ośrodek Badań Klinicznych Wczesnych Faz
Contact Person Name
Katarzyna Dziadziuszko
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Zakład Diagnostyki Obrazowej
Contact Person Name
Radosław Pietura
Contact Person Email
radoslawpietura@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
19-12-2025
Latest Decision Or Authorization Date
17-04-2026
Processing Time Days
119
Number Of Sites
7
Number Of Participants
50

Sites

Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Neuroscience, Imaging and Clinical Sciences
Contact Person Name
Massimo Caulo
Contact Person Email
massimo.caulo@unich.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
UOC Radiologia Toracica e cardiovascolare
Contact Person Name
Luigi Natale
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
Neuroradiologia
Contact Person Name
Simonetta Gerevini
Contact Person Email
sgerevini@asst-pg23.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Medicina Diagnostica e Radiologia
Contact Person Name
Carlo Catalano
Contact Person Email
carlo.catalano@uniroma1.it
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Radiologia
Contact Person Name
Giovanni Morana
Site Name
Azienda Ospedaliero-Universitaria Di Cagliari
Department Name
Radiologia
Contact Person Name
Luca Saba
Contact Person Email
lucasaba@unica.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Radiodiagnostica
Contact Person Name
Andrea Laghi
Contact Person Email
andrea.laghi@hunimed.eu

Sponsor

Primary sponsor

Full Name
Guerbet
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Fortrea Belgium
Responsibilities
Third-party listed under sponsor with sponsorDuties codes 1,12,2,8,9; contact submissions@fortrea.com

Third parties

  • {"country":"Belgium","full_name":"Fortrea Belgium","duties_or_roles":"sponsorDuties codes: 1,12,2,8,9; contact submissions@fortrea.com, +33147168200","organisation_type":"Pharmaceutical company"}

Co-sponsors

  • Bracco Imaging S.p.A.

Investigational products

Investigational Product Name
GADOPICLENOL
Active Substance
GADOPICLENOL
Modality
Small molecule
Routes Of Administration
Intravenous bolus injection/IV infusion
Route
Intravenous bolus injection/IV infusion
Authorisation Status
No marketing authorisation (marketingAuthNumber: -; prodAuthStatus: 2)
Starting Dose
0.05 mmol/kg (max total dose amount reported: 0.05 mmol/kg)
Dose Levels
0.05 mmol/kg (max total dose amount reported)
Maximum Dose
0.05 mmol/kg
Investigational Product Name
DOTAREM 0,5 mmol/mL, solution injectable
Active Substance
GADOTERIC ACID (gadoterate meglumine)
Modality
Small molecule
Routes Of Administration
Intravenous bolus injection/IV infusion
Route
Intravenous bolus injection/IV infusion
Authorisation Status
Authorised (marketingAuthNumber: 34009 331 715 7 5; authorisationCountryCode: FR; prodAuthStatus: 2)
Starting Dose
0.1 mmol/kg (max total dose amount reported: 0.1 mmol/kg)
Dose Levels
0.1 mmol/kg (max total dose amount reported)
Maximum Dose
0.1 mmol/kg

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