Trial Condition(s):
Comparison of Gadovist 75% standard dose to Dotarem at full standard dose (LEADER 75)
19773
Not Available
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.
- 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).
- No enhancing lesion visible on the gadoterate-enhanced MRI scan. - Pregnancy or breastfeeding. - Severe cardiovascular disease
Locations | |
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Locations Centre Hospitalier Lyon Sud PIERRE BENITE, France, 69495 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU STRASBOURG - Hôpital de Hautepierre STRASBOURG, France, 67098 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inselspital Universitätsspital Bern Bern, Switzerland, 3010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Seoul National University Hospital Seoul, South Korea, 03080 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ulsan University Hospital Ulsan, South Korea, 44033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Texas Southwestern Medical Center Dallas, United States, 75390 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Northwestern University Chicago, United States, 60611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mount Sinai Hospital New York City, United States, 10029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASL Provincia di Barletta-Andria-Trani Andria, Italy, 70031 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universität Rostock - Medizinische Fakultät Rostock, Germany, 18057 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ULSS2 Marca Trevigiana Treviso, Italy, 31100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Friedrich-Schiller-Uni. Jena Jena, Germany, 07740 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Schleswig-Holstein (UKSH) Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kantonsspital Aarau Aarau, Switzerland, 5001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Erlangen Erlangen, Germany, 91054 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Royal Preston Hospital Preston, United Kingdom, PR2 4HT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Penn State Milton S. Hershey Medical Center Hershey, United States, 17033 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
LowEr Administered Dose with highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Crossover Assignment
Trial Arms:
2