Clinical Trials

Inclusion Criteria:

• At the time of signing the informed consent at least 18 years of age and less than or equal to 89 years of age.
• Have known or highly suspected CNS pathology referred for contrast-enhanced MRI of the CNS based on current clinical symptoms or on a previous procedure.
• Have an estimated eGFR value ≥ 60 mL/min/1.73m^2 derived from a serum creatinine result within four weeks prior to study period 1.
• Be fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA) as applicable, and being capable and willing to consent to participate.

Exclusion Criteria:

• Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up.
• Any contraindication for MRI procedure or gadobutrol administration.
• Has severe cardiovascular disease (e.g., known long QT syndrome, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association class IV or acute stroke (< 48 hours).
• Is expected or is scheduled to have a change in any treatment or procedure between the two study periods that may alter image comparability.
• Is scheduled or is likely to require a biopsy or any interventional therapeutic procedure from the first study MRI up to 24 hours after the second study MRI.
• Women currently lactating, pregnant, or planning on becoming pregnant during the study.
• Women of childbearing potential with a positive urine pregnancy test within 24 hours before either gadobutrol administration.
• Receipt of any gadolinium-based contrast agent <72 h prior to the study MRIs.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/17/23. Questions regarding updates should be directed to the study team contact.