New contrast dye could sharpen brain scans
NCT ID NCT03996447
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This Phase 3 trial tested a new contrast agent called gadopiclenol for MRI scans of the brain and spine. The study involved 260 people with known or suspected central nervous system lesions. The goal was to see if gadopiclenol improves the visibility of lesions compared to scans without contrast and to an existing contrast agent.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gadopiclenol
- What this could lead to
- If successful, this could provide a safer and more effective contrast agent for MRI scans, helping doctors see brain and spine lesions more clearly.
- What could go wrong
- This is a completed Phase 3 trial, but results may not show a significant advantage over existing agents. Safety concerns with gadolinium-based contrasts remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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260 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Sep 2020
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ASCLEPES Research Centers
Panorama City, California, 91402, United States
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ASL 1 Abruzzo Avezzano-Sulmona-L'Aquila, Ospedale Regionale San Salvatore
L’Aquila, Italy
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Asan Medical Center
Seoul, 5505, South Korea
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Axis Heilsa S. de R.L. de C.V. (Althian)
Monterrey, 64060, Mexico
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Azienda Sanitaria Universitaria Integrata di Trieste-PO Cattinara
Trieste, 34149, Italy
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CHRU - Hôpital Roger Salengro - Neurologie
Lille, France
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CHRU Strasbourg Hôpital de Hautepierre
Strasbourg, 67098, France
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CHU La Miletrie
Poitiers, France
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Centre Hospitalier Sainte-Anne
Paris, 75014, France
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Clinical Research Institute S.C
Tlalnepantla, 54055, Mexico
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Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
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Fondazione I.R.C.C.S. C.Mondino
Pavia, 27100, Italy
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Hospital Clínico San Carlos
Madrid, 28040, Spain
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Hospital del Mar
Barcelona, 08003, Spain
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Istituto Neurologico Mediterraneo-Neuromed, I.R.C.C.S.
Pozzilli, 86077, Italy
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Konkuk University Medical Center
Seoul, 05030, South Korea
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M.D. Anderson Cancer Center Madrid
Madrid, 28033, Spain
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Northwest Neurology, Ltd.
Rolling Meadows, Illinois, 600008, United States
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Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
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Orszagos Klinikai Idegtudomanyi Intezet
Budapest, 1145, Hungary
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Pecsi Tudomanyegyetem Klinikai Kozpont - Idegsebeszeti Klinika
Pécs, Pécs, Hungary
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Semmelweis Egyetem - Neurology
Budapest, 1083, Hungary
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South Carolina Clinical & Translational Research (SCTR) Institute
Charleston, South Carolina, 29425, United States
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Szegedi Tudomanyegyetem AOK
Szeged, 6725, Hungary
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Taipei Veterans General Hospital
Taipei, 11217, Taiwan
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UZ Brussel - Campus Jette
Brussels, 1090, Belgium
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Uniklinik Mannheim
Mannheim, 68167, Germany
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University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University Of Washington - Medical Center
Seattle, Washington, 98195, United States
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University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
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University of Missouri Hospital and Clinic
Columbia, Missouri, 65212, United States
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Uniwersyteckie Centrum Kliniczne w Gdańsku, Zakład Radiologii
Gdansk, 80-214, Poland
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ZNA Middelheim
Antwerp, Belgium
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