MR Image Synthesis With Low Gadobutrol Dose and AI

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 brain lesions referred for contrast-enhanced MRI of the CNS.
• Have an estimated glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m^2.
• 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

• Considered clinically unstable or has a concomitant/intercurrent condition that would not allow participation in the study.
• Diagnoses of multiple sclerosis or other disease process that is expected to change its enhancement pattern in the time period of the follow-up.
• Brain pathology or abnormalities that are not considered lesions.
• Any contraindication for MRI procedure or gadobutrol administration.
• Has severe cardiovascular disease.
• 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 hours prior to the study MRIs.
• Participants with acute kidney injury.