Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

Completed · Phase 3

Conditions studied: Lesion in Body Region

In brief

The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

Key facts

Study ID

NCT03986138

Run by

Guerbet

People needed

324

Starts

2019-08-27

Expected to finish

2020-12-09

Last updated by the study team

2025-10-27

Who can join

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

You may qualify if…

• Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.

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 administration.

Where it is running

• The University of Alabama at Birmingham — Birmingham, Alabama, United States
• UConn Health - University of Connecticut — Farmington, Connecticut, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Missouri Health System — Columbia, Missouri, United States
• Montefiore Medical Center — The Bronx, New York, United States
• UT Health San Antonio — San Antonio, Texas, United States
• Acibadem City Clinic Tokuda Hospital Sofia — Sofia, Bulgaria
• CHU — Angers, France
• CHU Beaujon — Clichy, France
• Hôpital Saint Louis — Paris, France
• Klinik für Diagnostische und Interventionelle Radiologie — Aachen, Germany
• Universitätsklinikum Halle — Halle, Germany
• Universitätsklinikum des Saarlandes — Homburg, Germany
• University Hospital Jena — Jena, Germany
• Somogy Megyei Kaposi Mor Oktato Korhaz — Kaposvár, Hungary
• Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet — Szolnok, Hungary
• Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" — Naples, Italy
• Clinical Research Institute S.C. — Estado de México, Mexico
• Axis Heilsa S de R.L. de C.V - Althian Clinical Research Management Center — Monterrey, Mexico
• Szpital Uniwersytecki Nr 1 im. dr Antoniego Jurasza w Bydgoszczy — Bydgoszcz, Poland
• Uniwersyteckie Centrum Kliniczne — Gdansk, Poland
• Jagiellońskie Centrum Innowacji Sp. z o. o. — Krakow, Poland
• Szpital Świętego Rafała — Krakow, Poland
• Centrum Medyczne Affidea Wałbrzych — Wałbrzych, Poland

Full record on ClinicalTrials.gov

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