Clinical Indication for Brain MRI, Healthy Volunteers
Conditions
Keywords
neuroimaging
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 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.
Interventions
DEVICESyMRI 15 (3D)
Neurological MRI image collection
Sponsors
SyntheticMR
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
For each subject, conventional and synthetic images will be assessed by blinded, experienced neuroradiologists who will assess the images with regards to radiological findings, image quality, legibility of anatomical structures, and artifacts. The readings will be separated into two reading sessions with a 4-week memory-washout period.
Intervention model description
Subjects will be enrolled from the general imaging population scheduled for an MRI of the brain and healthy volunteers, using the scanner available at the investigational sites. A conventional MRI scan of the brain is taken, and an additional sequence that is processed into synthetic MR images. The conventional and the synthetic MR images from the same subject is compared.
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of Pathological Findings (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Specificity of Pathological Findings (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Classification of Pathological Findings | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Sensitivity (Adult Population) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings) for synthetic and conventional MR images in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Selectivity (Adult Population) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding) for synthetic and conventional MR images on the in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Classification of Pathological Findings (Adult Population) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Sensitivity (Pediatric Population) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings) for synthetic and conventional MR images in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Selectivity (Pediatric Population) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding) for synthetic and conventional MR images on the in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
| Classification of Pathological Findings (Pediatric Population) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Artifacts T1w(Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Presence and type of artifacts determined for synthetic T1w images, on the full analysis set determined by all readers. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each artifact per image type, independent of reading period, is summarized in corresponding row below. |
| Legibility T2w (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Legibility of anatomical structures, per structure, on the full analysis set for T2w images. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each anatomical structure per image type, independent of reading period, is summarized in corresponding row below. |
| Artifacts T2w(Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Presence and type of artifacts determined for synthetic T2w images, on the full analysis set determined by all readers. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each artifact per image type, independent of reading period, is summarized in corresponding row below. |
| Inter-rater Agreement (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Inter-rater agreement between all reader's assessment of pathological finding, as well as radiological finding classes, on the full analysis set. Each image was evaluated only once per reader and the agreement is independent of reading session. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The agreement was assessed separately per image type over both reading periods using overall agreement, Fleiss' kappa coefficient, and Gwet's AC1 coefficient. The first reading begun after all image processing was complete. |
| Inter-method Agreement (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Inter-method agreement between the different reader's assessment of pathological finding, as well as radiological finding classes, on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The agreement was evaluated for all images, independent of reading period and image type, using overall agreement, Fleiss' kappa coefficient, and Gwet's AC1 coefficient. The first reading begun after all image processing was complete. |
| Image Quality Score (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Image quality score (1 (Unacceptable) - 5 (Excellent)) per contrast weighting (T1w, T2w) per both image types (conventional and synthetic) where 3,4,5 are deemed acceptable for diagnostic use and 1,2 unacceptable for diagnostic use. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result presented, independent of reading period, is the averaged score per contrast weight and image type with the standard deviation. |
| Safety (Full Analysis Set) | Exam day (1 day), Generation of Synthetic Images (up to 7 weeks) | Incidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), Unanticipated Adverse Device Effect (UADE), Unanticipated Serious Adverse Device Effect (USADE) and Device Deficiencies (DD). The measurement was assessed in two periods: during exam day after signing consent form (all incidents applicable) and when generating the synthetic images (only device deficiencies) after all exams were performed. |
| Legibility T1w (Full Analysis Set) | Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8 | Legibility of anatomical structures, per structure, on the full analysis set for T1w images. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each anatomical structure per image type, independent of reading period, is summarized in corresponding row below. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neurological MRI Synthetic MR images of the brain acquired for post-processing with software (SyMRI 15, 3D).
Comparison is done between the conventional MR images and the post-processed synthetic MR images
SyMRI 15 (3D): Neurological MRI image collection. All participants with complete set of scans that was part of the image review study. | 189 |
| Total | 189 |
Baseline characteristics
| Characteristic | Neurological MRI Synthetic | — |
|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 23.1 | — |
| Age, Customized Adults (>= 18) | 126 Participants | — |
| Age, Customized Pediatric (<18 years) | 63 Participants | — |
| Anaesthesia used No | 184 Participants | — |
| Anaesthesia used Yes | 5 Participants | — |
| Pathological finding Congential malformations | 13 Participants | — |
| Pathological finding Infectious/inflammatory/demyelinating | 20 Participants | — |
| Pathological finding Intracranial neoplasms | 27 Participants | — |
| Pathological finding Neuro degenerative disorders and hydrocephalus | 13 Participants | — |
| Pathological finding Normal/no findings | 86 Participants | — |
| Pathological finding Toxic and metabolic conditions | 0 Participants | — |
| Pathological finding Traumatic lesions | 4 Participants | — |
| Pathological finding Vascular disorders of the brain | 26 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 189 participants | — |
| Sex: Female, Male Female | 107 Participants | — |
| Sex: Female, Male Male | 82 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 189 |
| other Total, other adverse events | 1 / 189 |
| serious Total, serious adverse events | 0 / 189 |
Outcome results
Primary
Sensitivity of Pathological Findings (Full Analysis Set)
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Sensitivity of Pathological Findings (Full Analysis Set) | Synthetic | 0.66 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Sensitivity of Pathological Findings (Full Analysis Set) | Conventional | 0.68 Proportion of participants |
Primary
Specificity of Pathological Findings (Full Analysis Set)
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding by reader) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Specificity of Pathological Findings (Full Analysis Set) | Synthetic | 0.85 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Specificity of Pathological Findings (Full Analysis Set) | Conventional | 0.85 Proportion of participants |
Secondary
Classification of Pathological Findings
Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Classification of Pathological Findings | Synthetic | 0.60 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Classification of Pathological Findings | Conventional | 0.60 Proportion of participants |
Secondary
Classification of Pathological Findings (Adult Population)
Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Population: Adult subpopulation 18-99 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Classification of Pathological Findings (Adult Population) | Synthetic | 0.61 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Classification of Pathological Findings (Adult Population) | Conventional | 0.61 Proportion of participants |
Secondary
Classification of Pathological Findings (Pediatric Population)
Diagnostic accuracy of radiological findings (radiological finding class) for synthetic and conventional MR images in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Population: Pediatric subpopulation 0-17 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Classification of Pathological Findings (Pediatric Population) | Synthetic | 0.57 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Classification of Pathological Findings (Pediatric Population) | Conventional | 0.58 Proportion of participants |
Secondary
Selectivity (Adult Population)
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding) for synthetic and conventional MR images on the in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Population: Adult subpopulation 18-99 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Selectivity (Adult Population) | Synthetic | 0.84 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Selectivity (Adult Population) | Conventional | 0.84 Proportion of participants |
Secondary
Selectivity (Pediatric Population)
Specificity of pathological findings (true number of participants with normal/no finding over assessed number of participants with normal/no finding) for synthetic and conventional MR images on the in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Population: Pediatric subpopulation 0-17 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Selectivity (Pediatric Population) | Synthetic | 0.90 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Selectivity (Pediatric Population) | Conventional | 0.87 Proportion of participants |
Secondary
Sensitivity (Adult Population)
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings) for synthetic and conventional MR images in adult population (18-99 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Population: Adult subpopulation 18-99 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Sensitivity (Adult Population) | Synthetic | 0.68 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Sensitivity (Adult Population) | Conventional | 0.70 Proportion of participants |
Secondary
Sensitivity (Pediatric Population)
Sensitivity of pathological findings (true number of participants with pathological findings over assessed number of participants with pathological findings) for synthetic and conventional MR images in pediatric population (0-17 years). Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The ground truth is the site-determined diagnosis.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
Population: Pediatric subpopulation 0-17 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Sensitivity (Pediatric Population) | Synthetic | 0.64 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Sensitivity (Pediatric Population) | Conventional | 0.64 Proportion of participants |
Other Pre-specified
Artifacts T1w(Full Analysis Set)
Presence and type of artifacts determined for synthetic T1w images, on the full analysis set determined by all readers. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each artifact per image type, independent of reading period, is summarized in corresponding row below.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | No artifacts : Synthetic | 851 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Motion artifacts : Synthetic | 29 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | In-folding or wrap around artifacts : Synthetic | 1 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Flow or phase-encoding artifacts : Synthetic | 4 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Magic angle effect artifacts : Synthetic | 1 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Water-fat shift/ chemical shift artifacts : Synthetic | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Magnetic susceptibility artifact : Synthetic | 55 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Low resolution : Synthetic | 7 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Low signal to noise : Synthetic | 4 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Low tissue contrast : Synthetic | 5 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | No artifacts : Conventional | 820 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Motion artifacts : Conventional | 40 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | In-folding or wrap around artifacts : Conventional | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Flow or phase-encoding artifacts : Conventional | 10 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Magic angle effect artifacts : Conventional | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Water-fat shift/ chemical shift artifacts : Conventional | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Magnetic susceptibility artifact : Conventional | 56 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Low resolution : Conventional | 17 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Low signal to noise : Conventional | 22 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T1w(Full Analysis Set) | Low tissue contrast : Conventional | 21 Number of observations |
Other Pre-specified
Artifacts T2w(Full Analysis Set)
Presence and type of artifacts determined for synthetic T2w images, on the full analysis set determined by all readers. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each artifact per image type, independent of reading period, is summarized in corresponding row below.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | No artifacts : Synthetic | 655 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | T2 weighted : Motion artifacts : Synthetic | 33 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | In-folding or wrap around artifacts : Synthetic | 1 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Flow or phase-encoding artifacts : Synthetic | 10 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Magic angle effect artifacts : Synthetic | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Water-fat shift/ chemical shift artifacts : Synthetic | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Magnetic susceptibility artifact : Synthetic | 51 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Low resolution : Synthetic | 106 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Low signal to noise : Synthetic | 30 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Low tissue contrast : Synthetic | 164 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | No artifacts : Conventional | 600 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Motion artifacts : Conventional | 40 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | In-folding or wrap around artifacts : Conventional | 4 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Flow or phase-encoding artifacts : Conventional | 207 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Magic angle effect artifacts : Conventional | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Water-fat shift/ chemical shift artifacts : Conventional | 0 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Magnetic susceptibility artifact : Conventional | 57 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Low resolution : Conventional | 66 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Low signal to noise : Conventional | 64 Number of observations |
| Neurologic Synthetic and Conventional MRI | Artifacts T2w(Full Analysis Set) | Low tissue contrast : Conventional | 56 Number of observations |
Other Pre-specified
Image Quality Score (Full Analysis Set)
Image quality score (1 (Unacceptable) - 5 (Excellent)) per contrast weighting (T1w, T2w) per both image types (conventional and synthetic) where 3,4,5 are deemed acceptable for diagnostic use and 1,2 unacceptable for diagnostic use. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result presented, independent of reading period, is the averaged score per contrast weight and image type with the standard deviation.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Image Quality Score (Full Analysis Set) | T1w : Synthetic | 4.6 score on a scale | Standard Deviation 0.6 |
| Neurologic Synthetic and Conventional MRI | Image Quality Score (Full Analysis Set) | T1w : Conventional | 4.5 score on a scale | Standard Deviation 0.7 |
| Neurologic Synthetic and Conventional MRI | Image Quality Score (Full Analysis Set) | T2w : Synthetic | 4.4 score on a scale | Standard Deviation 0.7 |
| Neurologic Synthetic and Conventional MRI | Image Quality Score (Full Analysis Set) | T2w : Conventional | 4.2 score on a scale | Standard Deviation 0.8 |
Other Pre-specified
Inter-method Agreement (Full Analysis Set)
Inter-method agreement between the different reader's assessment of pathological finding, as well as radiological finding classes, on the full analysis set. Each image was evaluated only once per reader. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The agreement was evaluated for all images, independent of reading period and image type, using overall agreement, Fleiss' kappa coefficient, and Gwet's AC1 coefficient. The first reading begun after all image processing was complete.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Inter-method Agreement (Full Analysis Set) | Pathological finding: Overall agreement | 0.86 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-method Agreement (Full Analysis Set) | Pathological finding: Fleiss' kappa coefficient | 0.71 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-method Agreement (Full Analysis Set) | Pathological finding: Gwet's AC1 coefficient | 0.72 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-method Agreement (Full Analysis Set) | Radiological finding class: Overall agreement | 0.75 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-method Agreement (Full Analysis Set) | Radiological finding class: Fleiss' kappa coefficient | 0.61 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-method Agreement (Full Analysis Set) | Radiological finding class: Gwet's AC1 coefficient | 0.73 Proportion of participants |
Other Pre-specified
Inter-rater Agreement (Full Analysis Set)
Inter-rater agreement between all reader's assessment of pathological finding, as well as radiological finding classes, on the full analysis set. Each image was evaluated only once per reader and the agreement is independent of reading session. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The agreement was assessed separately per image type over both reading periods using overall agreement, Fleiss' kappa coefficient, and Gwet's AC1 coefficient. The first reading begun after all image processing was complete.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Pathological finding: Overall agreement (Synthetic) | 0.82 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Pathological finding: Fleiss' kappa coefficient (Synthetic) | 0.64 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Pathological finding: Gwet's AC1 coefficient (Synthetic) | 0.65 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Radiological finding class: Overall agreement (Synthetic) | 0.67 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Radiological finding class: Fleiss' kappa coefficient (Synthetic) | 0.48 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Radiological finding class: Gwet's AC1 coefficient (Synthetic) | 0.63 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Pathological finding: Overall agreement (Conventional) | 0.82 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Pathological finding: Fleiss' kappa coefficient (Conventional) | 0.63 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Pathological finding: Gwet's AC1 coefficient (Conventional) | 0.64 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Radiological finding class: Overall agreement (Conventional) | 0.67 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Radiological finding class: Fleiss' kappa coefficient (Conventional) | 0.48 Proportion of participants |
| Neurologic Synthetic and Conventional MRI | Inter-rater Agreement (Full Analysis Set) | Radiological finding class: Gwet's AC1 coefficient (Conventional) | 0.63 Proportion of participants |
Other Pre-specified
Legibility T1w (Full Analysis Set)
Legibility of anatomical structures, per structure, on the full analysis set for T1w images. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each anatomical structure per image type, independent of reading period, is summarized in corresponding row below.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Central sulcus : Synthetic | 940 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Cerebral peduncle : Synthetic | 944 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Cervicomedullary junction : Synthetic | 944 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Head of caudate nucleus : Synthetic | 942 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Middle cerebellar peducle : Synthetic | 944 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Posterior limb of internal capsule : Synthetic | 942 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Central sulcus : Conventional | 938 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Cerebral peduncle : Conventional | 940 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Cervicomedullary junction : Conventional | 944 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Head of caudate nucleus : Conventional | 936 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Middle cerebellar peducle : Conventional | 943 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T1w (Full Analysis Set) | Posterior limb of internal capsule : Conventional | 933 Number of observations |
Other Pre-specified
Legibility T2w (Full Analysis Set)
Legibility of anatomical structures, per structure, on the full analysis set for T2w images. The images were split between two readings, with a wash-out period of 4 weeks in between. Both readings contained both types of images, synthetic and conventional. The first reading begun after all image processing was complete. The result for each anatomical structure per image type, independent of reading period, is summarized in corresponding row below.
Time frame: Conventional images and necessary MRI information acquired from participant on exam day (1 day). Synthetic images generated before first reading. Analysis by readers in two readings, first reading: week 0-2, second reading: week 7-8
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Central sulcus : Synthetic | 939 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Cerebral peduncle : Synthetic | 942 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Cervicomedullary junction : Synthetic | 943 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Head of caudate nucleus : Synthetic | 934 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Middle cerebellar peducle : Synthetic | 944 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Posterior limb of internal capsule : Synthetic | 937 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Central sulcus : Conventional | 941 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Cerebral peduncle : Conventional | 942 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Cervicomedullary junction : Conventional | 927 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Head of caudate nucleus : Conventional | 923 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Middle cerebellar peducle : Conventional | 942 Number of observations |
| Neurologic Synthetic and Conventional MRI | Legibility T2w (Full Analysis Set) | Posterior limb of internal capsule : Conventional | 921 Number of observations |
Other Pre-specified
Safety (Full Analysis Set)
Incidence of Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Events (SAE), Serious Adverse Device Effects (SADE), Unanticipated Adverse Device Effect (UADE), Unanticipated Serious Adverse Device Effect (USADE) and Device Deficiencies (DD). The measurement was assessed in two periods: during exam day after signing consent form (all incidents applicable) and when generating the synthetic images (only device deficiencies) after all exams were performed.
Time frame: Exam day (1 day), Generation of Synthetic Images (up to 7 weeks)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neurologic Synthetic and Conventional MRI | Safety (Full Analysis Set) | Adverse Events (AE) | 0 events |
| Neurologic Synthetic and Conventional MRI | Safety (Full Analysis Set) | Adverse Device Effects (ADE) | 0 events |
| Neurologic Synthetic and Conventional MRI | Safety (Full Analysis Set) | Serious Adverse Events (SAE) | 0 events |
| Neurologic Synthetic and Conventional MRI | Safety (Full Analysis Set) | Unanticipated Adverse Device Effect (UADE) | 0 events |
| Neurologic Synthetic and Conventional MRI | Safety (Full Analysis Set) | Unanticipated Serious Adverse Device Effect (USADE) | 0 events |
| Neurologic Synthetic and Conventional MRI | Safety (Full Analysis Set) | Device Deficiencies (DD) | 1 events |