Status:
COMPLETED
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
Lead Sponsor:
SyntheticMR
Conditions:
Clinical Indication for Brain MRI
Healthy Volunteers
Eligibility:
All Genders
Up to 99 years
Phase:
NA
Brief Summary
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
Detailed 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 im...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT05425927
Start Date
June 27 2022
End Date
July 31 2024
Last Update
April 23 2025
Active Locations (6)
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1
Phoenix Children's hospital
Phoenix, Arizona, United States, 85016
2
ProScan Imaging
Naples, Florida, United States, 34110
3
Nemours Children's Health, Nemours Children's Hospital, Florida
Orlando, Florida, United States, 32827
4
SimonMed imaging Streeterville
Chicago, Illinois, United States, 606117110