Trial Condition(s):

Magnetic Resonance Imaging

Comparison of Gadovist 75% standard dose to Dotarem at full standard dose (LEADER 75)

Bayer Identifier:

19773

ClinicalTrials.gov Identifier:

NCT03602339

EudraCT Number:

2018-000690-78

Study Completed

Trial Purpose

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.

Inclusion Criteria
- 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).
Exclusion Criteria
- No enhancing lesion visible on the gadoterate-enhanced MRI scan.
                - Pregnancy or breastfeeding.
                - Severe cardiovascular disease

Trial Summary

Enrollment Goal
157
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Centre Hospitalier Lyon Sud

PIERRE BENITE, France, 69495

Status
Completed
 
Locations

CHU STRASBOURG - Hôpital de Hautepierre

STRASBOURG, France, 67098

Status
Completed
 
Locations

Inselspital Universitätsspital Bern

Bern, Switzerland, 3010

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 03080

Status
Completed
 
Locations

Ulsan University Hospital

Ulsan, South Korea, 44033

Status
Completed
 
Locations

University of Texas Southwestern Medical Center

Dallas, United States, 75390

Status
Completed
 
Locations

Northwestern University

Chicago, United States, 60611

Status
Completed
 
Locations

Mount Sinai Hospital

New York City, United States, 10029

Status
Completed
 
Locations

ASL Provincia di Barletta-Andria-Trani

Andria, Italy, 70031

Status
Completed
 
Locations

Universität Rostock - Medizinische Fakultät

Rostock, Germany, 18057

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

ULSS2 Marca Trevigiana

Treviso, Italy, 31100

Status
Completed
 
Locations

Friedrich-Schiller-Uni. Jena

Jena, Germany, 07740

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Germany, 24105

Status
Completed
 
Locations

Kantonsspital Aarau

Aarau, Switzerland, 5001

Status
Completed
 
Locations

Universitätsklinikum Erlangen

Erlangen, Germany, 91054

Status
Completed
 
Locations

Universitätsklinikum Leipzig AöR

Leipzig, Germany, 04103

Status
Completed
 
Locations

Royal Preston Hospital

Preston, United Kingdom, PR2 4HT

Status
Completed
 
Locations

Penn State Milton S. Hershey Medical Center

Hershey, United States, 17033

Status
Completed
 

Trial Design