Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

Completed · Phase 4

Conditions studied: Magnetic Resonance Imaging

In brief

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

Key facts

Study ID

NCT03602339

Run by

Bayer

People needed

157

Starts

2018-11-14

Expected to finish

2020-05-26

Last updated by the study team

2021-06-14

Who can join

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

You may qualify if…

• Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.
• Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.
• Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).

You may not qualify if…

• No enhancing lesion visible on the gadoterate-enhanced MRI scan.
• Pregnancy or breastfeeding.
• Severe cardiovascular disease

Where it is running

• Northwestern University — Chicago, Illinois, United States
• Mount Sinai Hospital — New York, New York, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Centre Hospitalier Lyon Sud — Pierre-Bénite, France
• CHU STRASBOURG - Hôpital de Hautepierre — Strasbourg, France
• Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany
• Universität Rostock - Medizinische Fakultät — Rostock, Mecklenburg-Vorpommern, Germany
• Universitätsklinikum Leipzig AöR — Leipzig, Saxony, Germany
• Universitätsklinikum Schleswig-Holstein (UKSH) — Kiel, Schleswig-Holstein, Germany
• Universitätsklinikum Schleswig-Holstein / AÖR — Lübeck, Schleswig-Holstein, Germany
• Friedrich-Schiller-Uni. Jena — Jena, Thuringia, Germany
• ASL Provincia di Barletta-Andria-Trani — Andria, Apulia, Italy
• A.O.U. Pisana — Pisa, Tuscany, Italy
• ULSS2 Marca Trevigiana — Treviso, Veneto, Italy
• Ulsan University Hospital — Ulsan, Ulsan Gwang''yeogsi, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Kantonsspital Aarau — Aarau, Canton of Aargau, Switzerland
• Inselspital Universitätsspital Bern — Bern, Switzerland
• Royal Preston Hospital — Preston, Lancashire, United Kingdom

Full record on ClinicalTrials.gov

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