Status
Conditions
Treatments
About
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
Full description
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:
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
189 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal