Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Launched by BAYER · Jul 18, 2018
Trial Information
Current as of June 30, 2025
Completed
Keywords
ClinConnect Summary
The study was 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 was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).
Gender
ALL
Eligibility criteria
- 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
About Bayer
Bayer is a global healthcare and life sciences company dedicated to advancing health and well-being through innovative research and development. With a strong commitment to improving patient outcomes, Bayer conducts clinical trials across various therapeutic areas, including oncology, cardiology, and women's health. The company leverages cutting-edge science and technology to develop breakthrough therapies, while adhering to the highest standards of ethical practices and regulatory compliance. Through collaboration with healthcare professionals and research institutions, Bayer aims to bring transformative solutions to the market, ultimately enhancing the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Pierre Benite, , France
New York, New York, United States
Dallas, Texas, United States
Hershey, Pennsylvania, United States
Seoul, , Korea, Republic Of
Erlangen, Bayern, Germany
Seoul, , Korea, Republic Of
Leipzig, Sachsen, Germany
Aarau, Aargau, Switzerland
Pisa, Toscana, Italy
Strasbourg, , France
Bern, , Switzerland
Rostock, Mecklenburg Vorpommern, Germany
Kiel, Schleswig Holstein, Germany
Lübeck, Schleswig Holstein, Germany
Jena, Thüringen, Germany
Andria, Puglia, Italy
Treviso, Veneto, Italy
Ulsan, Ulsan Gwang''Yeogsi, Korea, Republic Of
Preston, Lancashire, United Kingdom
Jena, , Germany
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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