Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Completed · Phase 3

Conditions studied: CNS Lesion, Blood Brain Barrier Defect

In brief

This trial aimed to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

Key facts

Study ID

NCT03996447

Run by

Guerbet

People needed

260

Starts

2019-06-03

Expected to finish

2020-09-11

Last updated by the study team

2025-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient presenting with known or highly suspected CNS lesion(s) with focal areas of disrupted Blood Brain Barrier (BBB) (e.g., primary and secondary tumors) based on results of a previous imaging procedure such as Computed Tomography (CT) or MRI, which should have been performed within 12 months prior to ICF signature.

You may not qualify if…

• Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent injection
• Patient presenting extra cranial lesions and/or extra-dural lesions.

Where it is running

• ASCLEPES Research Centers — Panorama City, California, United States
• University of Connecticut Health Center — Farmington, Connecticut, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Northwest Neurology, Ltd. — Rolling Meadows, Illinois, United States
• University of Missouri Hospital and Clinic — Columbia, Missouri, United States
• University Of Pennsylvania — Philadelphia, Pennsylvania, United States
• South Carolina Clinical & Translational Research (SCTR) Institute — Charleston, South Carolina, United States
• University Of Washington - Medical Center — Seattle, Washington, United States
• ZNA Middelheim — Antwerp, Belgium
• UZ Brussel - Campus Jette — Brussels, Belgium
• CHRU - Hôpital Roger Salengro - Neurologie — Lille, France
• Centre Hospitalier Sainte-Anne — Paris, France
• CHU La Miletrie — Poitiers, France
• CHRU Strasbourg Hôpital de Hautepierre — Strasbourg, France
• Uniklinik Mannheim — Mannheim, Germany
• Semmelweis Egyetem - Neurology — Budapest, Hungary
• Orszagos Klinikai Idegtudomanyi Intezet — Budapest, Hungary
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
• Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika — Pécs, Hungary
• Szegedi Tudomanyegyetem AOK — Szeged, Hungary
• ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore — L’Aquila, Italy
• Fondazione I.R.C.C.S. C.Mondino — Pavia, Italy
• Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S. — Pozzilli, Italy
• Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara — Trieste, Italy
• Axis Heilsa S. de R.L. de C.V. (Althian) — Monterrey, Mexico

Full record on ClinicalTrials.gov

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