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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:November 14, 2018
End Date:January 31, 2020
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

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LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem

The study is being 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 is 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 is used.

The study is an open-label, multi-center, comparative, cross-over trial in adult patients
with known or highly suspected CNS pathology who were referred for imaging of the CNS.

The primary objective of the study is to demonstrate the non-inferiority of gadobutrol (0.075
mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).

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
We found this trial at
9
sites
New York, New York 10029
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Hershey, PA
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Pierre Benite, 69495
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Pierre Benite,
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Spokane, Washington 99208
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Spokane, WA
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West Palm Beach, Florida 33407
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West Palm Beach, FL
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