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 |
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.
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).
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
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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500 University Dr
Hershey, Pennsylvania 17033
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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