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Clinical Trials in Germany / NCT07348640
Recruiting Phase 3

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 · tracked via the Priya Life Science Germany tracker
Sponsor
Guerbet
Phase
Phase 3
Started
2026-07-28
Last updated
2026-08-13

Condition(s) studied

Steno-occlusive Disease

Investigational drug(s) / intervention(s)

gadopiclenol →Gadoterate meglumine (Dotarem) →

gadopiclenol: Gadopiclenol enhanced-Magnetic Resonance Angiography

Gadoterate meglumine (Dotarem): Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
University of California Los Angeles (UCLA) Los Angeles California Not Yet Recruiting
UCHealth University of Colorado Hospital Aurora Colorado Not Yet Recruiting
Northshore - Evanston Hospital Evanston Illinois Not Yet Recruiting
Mayo Clinic Rochester Minnesota Not Yet Recruiting
Houston Methodist Hospital Houston Texas Not Yet Recruiting
University of Washington Seattle Washington Not Yet Recruiting
Centre Hospitalier de l'Université de Montréal Montreal Quebec Not Yet Recruiting
Department of Radiology and Nuclear Medicine, University Hospital Brno Brno Czechia Not Yet Recruiting
Motol University Hospital Prague Czechia Not Yet Recruiting
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin Bordeaux France Not Yet Recruiting
Hôpital Cardiovasculaire et Pneumologique Bron France Not Yet Recruiting
CHU Dijon Bourgogne Dijon France Not Yet Recruiting
CHU de Poitiers Poitiers France Not Yet Recruiting
Charité - Universitätsmedizin Berlin Berlin Germany Not Yet Recruiting
University Hospital Bonn Bonn Germany Not Yet Recruiting
UH Essen Essen Germany Not Yet Recruiting
University Hospital of Saarland Homburg Germany Not Yet Recruiting
Klinik fuer Diagnostische Radiologie and Neuroradiologie Kiel Germany Not Yet Recruiting
Department of Neuroradiology, UKSH Campus Lübeck Lübeck Germany Not Yet Recruiting
LMU University Hospital München Germany Not Yet Recruiting
Semmelweis University - Budapest Budapest Hungary Not Yet Recruiting
University of Debrecen - Debrecen Debrecen Hungary Recruiting
University of Pecs Clinical Centre Pécs Hungary Recruiting
Reparto di Neuroradiologia ASST Ospedale Papa Giovanni XXIII Bergamo Italy Not Yet Recruiting
Azienda Ospedaliera di Monserrato Cagliari Italy Not Yet Recruiting
ITAB -Institute of Advanced Biomedical Technologies University d'Annunzio of Chieti-Pescara Chieti Italy Not Yet Recruiting
Department of Diagnostic Imaging, Humanitas Research Hospital Milan Italy Not Yet Recruiting
Diagnostica per Immagini e Interventistica Ospedale Umberto I Roma Italy Not Yet Recruiting
Catholic University - Fondazione Policlinico Gemelli Advanced Radiology Center - Diagnostic Imaging and Oncologic Radiotherapy Dept. IRCCS Rome Roma Italy Not Yet Recruiting
Ospedale Ca' Foncello Treviso Italy Not Yet Recruiting
University Hospital No.1, Department of Radiology and Diagnostic Imagine Bydgoszcz Poland Not Yet Recruiting
Radiology Department, Uniwersyteckie Centrum Kliniczne w Gdansku Gdansk Poland Not Yet Recruiting
Medical University Lublin, Diagnostic Imaging Department Lublin Poland Not Yet Recruiting
Yonsei University Gangnam Severance Hospital Seoul Gangnam-gu Not Yet Recruiting
Seoul National University Hospital Seoul Jongno-gu Not Yet Recruiting
Seoul St. Mary's Hospital Seoul Seocho-gu Not Yet Recruiting
Asan Medical Center Seoul Songpa-gu Not Yet Recruiting
Ajou University Hospital Gyeonggi-do Suwon-si Not Yet Recruiting
Diagnòstic per la Imatge Barcelona Spain Not Yet Recruiting
Hospital Clínico San Cecilio Granada Spain Not Yet Recruiting

+ 1 more sites — see the full list on the official registry below.

More Guerbet trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07348640 on ClinicalTrials.gov ↗ ← All trials in Germany