N/A
N=189
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
Clinical Indication for Brain MRI · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05425927 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Sensitivity of Pathological Findings (Full Analysis Set) — 0.66; 0.68 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SyMRI 15 (3D) (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- SyntheticMR
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity of Pathological Findings (Full Analysis Set) |
0.66; 0.68 | — |
| PRIMARY Specificity of Pathological Findings (Full Analysis Set) |
0.85; 0.85 | — |
| SECONDARY Classification of Pathological Findings |
0.60; 0.60 | — |
| SECONDARY Sensitivity (Adult Population) |
0.68; 0.70 | — |
| SECONDARY Selectivity (Adult Population) |
0.84; 0.84 | — |
| SECONDARY Classification of Pathological Findings (Adult Population) |
0.61; 0.61 | — |
| SECONDARY Sensitivity (Pediatric Population) |
0.64; 0.64 | — |
| SECONDARY Selectivity (Pediatric Population) |
0.90; 0.87 | — |
| SECONDARY Classification of Pathological Findings (Pediatric Population) |
0.57; 0.58 | — |
Summary
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05425927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.