Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain

Validation of 3D Synthetic MRI for Neuroimaging - Prospective, Multicenter, Multireader Investigation

This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,

This study is a prospective, blinded, multi-center, multi-reader clinical study that is statistically powered for demonstrating non-inferiority of synthetic 3D MR images compared to conventional MR images with respect to sensitivity and specificity of pathological findings.

The study consists of three parts:

• Clinical MR acquisition,
• Synthetic MR post-processing
• Blinded image evaluation of conventional and synthetic images for each subject.

The study will enroll eligible subjects with an already scheduled brain MRI and also healthy volunteers, that meet applicable site MR safety criteria. The routine MRI scan will include approximately 5-20 minutes extra time for the additional images to be taken. This time will be added to the length of the scheduled scan. It is only the time in the MRI scanner that will differ from standard procedures, no other examinations will be performed.

The study consists of one visit, without additional follow-up.

Inclusion Criteria:

• Any gender, aged 0-99 years
• Subject scheduled for MRI of the brain OR Healthy control with passed screening form
• Subject suitable for MRI as judged by investigator
• Subject agrees to 5-20 min extra MRI scan time
• Subject able to understand written and verbal information in English or Spanish
• Provision of informed consent (and assent if applicable)

Exclusion Criteria:

• Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site
• Have severe trauma, disability or pre-existing pathology that is expected to interfere with normal conduct of MRI scanning or complete scanning of the brain
• Have medical condition(s) such as those requiring urgent medical care that, in the opinion of a physician investigator, would prevent safe participation in the study
• Adult subjects (aged 18-99 years) in need of anesthesia during MRI scanning
• Pregnancy at time of enrollment determined according to the clinic's MR Safety Screening policy
• Previous enrollment in this investigation