Trial Outcomes & Findings for Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain (NCT NCT05425927)
NCT ID: NCT05425927
Last Updated: 2025-04-23
Results Overview
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.
COMPLETED
NA
189 participants
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
2025-04-23
Participant Flow
Participant milestones
| Measure |
Neurological MRI
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.
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|---|---|
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Overall Study
STARTED
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189
|
|
Overall Study
COMPLETED
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189
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Neurological MRI Synthetic
n=189 Participants
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.
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|---|---|
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Age, Continuous
|
35.4 years
STANDARD_DEVIATION 23.1 • n=189 Participants
|
|
Age, Customized
Pediatric (<18 years)
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63 Participants
n=189 Participants
|
|
Age, Customized
Adults (>= 18)
|
126 Participants
n=189 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=189 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=189 Participants
|
|
Region of Enrollment
United States
|
189 participants
n=189 Participants
|
|
Pathological finding
Congential malformations
|
13 Participants
n=189 Participants
|
|
Pathological finding
Infectious/inflammatory/demyelinating
|
20 Participants
n=189 Participants
|
|
Pathological finding
Intracranial neoplasms
|
27 Participants
n=189 Participants
|
|
Pathological finding
Toxic and metabolic conditions
|
0 Participants
n=189 Participants
|
|
Pathological finding
Traumatic lesions
|
4 Participants
n=189 Participants
|
|
Pathological finding
Vascular disorders of the brain
|
26 Participants
n=189 Participants
|
|
Pathological finding
Neuro degenerative disorders and hydrocephalus
|
13 Participants
n=189 Participants
|
|
Pathological finding
Normal/no findings
|
86 Participants
n=189 Participants
|
|
Anaesthesia used
Yes
|
5 Participants
n=189 Participants
|
|
Anaesthesia used
No
|
184 Participants
n=189 Participants
|
PRIMARY outcome
Timeframe: 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 7-8Sensitivity 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Sensitivity of Pathological Findings (Full Analysis Set)
Synthetic
|
0.66 Proportion of participants
Interval 0.59 to 0.74
|
|
Sensitivity of Pathological Findings (Full Analysis Set)
Conventional
|
0.68 Proportion of participants
Interval 0.6 to 0.75
|
PRIMARY outcome
Timeframe: 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 7-8Specificity 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Specificity of Pathological Findings (Full Analysis Set)
Synthetic
|
0.85 Proportion of participants
Interval 0.81 to 0.9
|
|
Specificity of Pathological Findings (Full Analysis Set)
Conventional
|
0.85 Proportion of participants
Interval 0.8 to 0.9
|
SECONDARY outcome
Timeframe: 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 7-8Diagnostic 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Classification of Pathological Findings
Synthetic
|
0.60 Proportion of participants
Interval 0.55 to 0.65
|
|
Classification of Pathological Findings
Conventional
|
0.60 Proportion of participants
Interval 0.55 to 0.65
|
SECONDARY outcome
Timeframe: 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 7-8Population: Adult subpopulation 18-99 years
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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=126 Participants
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.
|
|---|---|
|
Sensitivity (Adult Population)
Synthetic
|
0.68 Proportion of participants
Interval 0.58 to 0.78
|
|
Sensitivity (Adult Population)
Conventional
|
0.70 Proportion of participants
Interval 0.61 to 0.79
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SECONDARY outcome
Timeframe: 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 7-8Population: Adult subpopulation 18-99 years
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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=126 Participants
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.
|
|---|---|
|
Selectivity (Adult Population)
Synthetic
|
0.84 Proportion of participants
Interval 0.78 to 0.9
|
|
Selectivity (Adult Population)
Conventional
|
0.84 Proportion of participants
Interval 0.78 to 0.91
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SECONDARY outcome
Timeframe: 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 7-8Population: Adult subpopulation 18-99 years
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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=126 Participants
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.
|
|---|---|
|
Classification of Pathological Findings (Adult Population)
Synthetic
|
0.61 Proportion of participants
Interval 0.55 to 0.68
|
|
Classification of Pathological Findings (Adult Population)
Conventional
|
0.61 Proportion of participants
Interval 0.54 to 0.67
|
SECONDARY outcome
Timeframe: 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 7-8Population: Pediatric subpopulation 0-17 years
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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=63 Participants
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.
|
|---|---|
|
Sensitivity (Pediatric Population)
Synthetic
|
0.64 Proportion of participants
Interval 0.52 to 0.76
|
|
Sensitivity (Pediatric Population)
Conventional
|
0.64 Proportion of participants
Interval 0.52 to 0.76
|
SECONDARY outcome
Timeframe: 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 7-8Population: Pediatric subpopulation 0-17 years
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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=63 Participants
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.
|
|---|---|
|
Selectivity (Pediatric Population)
Synthetic
|
0.90 Proportion of participants
Interval 0.83 to 0.97
|
|
Selectivity (Pediatric Population)
Conventional
|
0.87 Proportion of participants
Interval 0.8 to 0.95
|
SECONDARY outcome
Timeframe: 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 7-8Population: Pediatric subpopulation 0-17 years
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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=63 Participants
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.
|
|---|---|
|
Classification of Pathological Findings (Pediatric Population)
Synthetic
|
0.57 Proportion of participants
Interval 0.48 to 0.67
|
|
Classification of Pathological Findings (Pediatric Population)
Conventional
|
0.58 Proportion of participants
Interval 0.49 to 0.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Legibility 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=945 Number of observations
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.
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|---|---|
|
Legibility T1w (Full Analysis Set)
Central sulcus : Synthetic
|
940 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Cerebral peduncle : Synthetic
|
944 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Cervicomedullary junction : Synthetic
|
944 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Head of caudate nucleus : Synthetic
|
942 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Middle cerebellar peducle : Synthetic
|
944 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Posterior limb of internal capsule : Synthetic
|
942 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Central sulcus : Conventional
|
938 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Cerebral peduncle : Conventional
|
940 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Cervicomedullary junction : Conventional
|
944 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Head of caudate nucleus : Conventional
|
936 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Middle cerebellar peducle : Conventional
|
943 Number of observations
|
|
Legibility T1w (Full Analysis Set)
Posterior limb of internal capsule : Conventional
|
933 Number of observations
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Legibility 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=945 Number of observations
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.
|
|---|---|
|
Legibility T2w (Full Analysis Set)
Central sulcus : Synthetic
|
939 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Cerebral peduncle : Synthetic
|
942 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Cervicomedullary junction : Synthetic
|
943 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Head of caudate nucleus : Synthetic
|
934 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Middle cerebellar peducle : Synthetic
|
944 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Posterior limb of internal capsule : Synthetic
|
937 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Central sulcus : Conventional
|
941 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Cerebral peduncle : Conventional
|
942 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Cervicomedullary junction : Conventional
|
927 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Head of caudate nucleus : Conventional
|
923 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Middle cerebellar peducle : Conventional
|
942 Number of observations
|
|
Legibility T2w (Full Analysis Set)
Posterior limb of internal capsule : Conventional
|
921 Number of observations
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Presence 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=945 Number of observations
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.
|
|---|---|
|
Artifacts T1w(Full Analysis Set)
No artifacts : Synthetic
|
851 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Motion artifacts : Synthetic
|
29 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
In-folding or wrap around artifacts : Synthetic
|
1 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Flow or phase-encoding artifacts : Synthetic
|
4 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Magic angle effect artifacts : Synthetic
|
1 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Water-fat shift/ chemical shift artifacts : Synthetic
|
0 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Magnetic susceptibility artifact : Synthetic
|
55 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Low resolution : Synthetic
|
7 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Low signal to noise : Synthetic
|
4 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Low tissue contrast : Synthetic
|
5 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
No artifacts : Conventional
|
820 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Motion artifacts : Conventional
|
40 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
In-folding or wrap around artifacts : Conventional
|
0 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Flow or phase-encoding artifacts : Conventional
|
10 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Magic angle effect artifacts : Conventional
|
0 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Water-fat shift/ chemical shift artifacts : Conventional
|
0 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Magnetic susceptibility artifact : Conventional
|
56 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Low resolution : Conventional
|
17 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Low signal to noise : Conventional
|
22 Number of observations
|
|
Artifacts T1w(Full Analysis Set)
Low tissue contrast : Conventional
|
21 Number of observations
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Presence 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=945 Number of observations
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.
|
|---|---|
|
Artifacts T2w(Full Analysis Set)
Magic angle effect artifacts : Conventional
|
0 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
No artifacts : Synthetic
|
655 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
T2 weighted : Motion artifacts : Synthetic
|
33 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
In-folding or wrap around artifacts : Synthetic
|
1 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Flow or phase-encoding artifacts : Synthetic
|
10 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Magic angle effect artifacts : Synthetic
|
0 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Water-fat shift/ chemical shift artifacts : Synthetic
|
0 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Magnetic susceptibility artifact : Synthetic
|
51 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Low resolution : Synthetic
|
106 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Low signal to noise : Synthetic
|
30 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Low tissue contrast : Synthetic
|
164 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
No artifacts : Conventional
|
600 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Motion artifacts : Conventional
|
40 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
In-folding or wrap around artifacts : Conventional
|
4 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Flow or phase-encoding artifacts : Conventional
|
207 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Water-fat shift/ chemical shift artifacts : Conventional
|
0 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Magnetic susceptibility artifact : Conventional
|
57 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Low resolution : Conventional
|
66 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Low signal to noise : Conventional
|
64 Number of observations
|
|
Artifacts T2w(Full Analysis Set)
Low tissue contrast : Conventional
|
56 Number of observations
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Inter-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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Inter-rater Agreement (Full Analysis Set)
Pathological finding: Overall agreement (Synthetic)
|
0.82 Proportion of participants
Interval 0.79 to 0.86
|
|
Inter-rater Agreement (Full Analysis Set)
Pathological finding: Fleiss' kappa coefficient (Synthetic)
|
0.64 Proportion of participants
Interval 0.57 to 0.71
|
|
Inter-rater Agreement (Full Analysis Set)
Pathological finding: Gwet's AC1 coefficient (Synthetic)
|
0.65 Proportion of participants
Interval 0.58 to 0.72
|
|
Inter-rater Agreement (Full Analysis Set)
Radiological finding class: Overall agreement (Synthetic)
|
0.67 Proportion of participants
Interval 0.62 to 0.71
|
|
Inter-rater Agreement (Full Analysis Set)
Radiological finding class: Fleiss' kappa coefficient (Synthetic)
|
0.48 Proportion of participants
Interval 0.42 to 0.53
|
|
Inter-rater Agreement (Full Analysis Set)
Radiological finding class: Gwet's AC1 coefficient (Synthetic)
|
0.63 Proportion of participants
Interval 0.58 to 0.68
|
|
Inter-rater Agreement (Full Analysis Set)
Pathological finding: Overall agreement (Conventional)
|
0.82 Proportion of participants
Interval 0.78 to 0.85
|
|
Inter-rater Agreement (Full Analysis Set)
Pathological finding: Fleiss' kappa coefficient (Conventional)
|
0.63 Proportion of participants
Interval 0.55 to 0.7
|
|
Inter-rater Agreement (Full Analysis Set)
Pathological finding: Gwet's AC1 coefficient (Conventional)
|
0.64 Proportion of participants
Interval 0.57 to 0.71
|
|
Inter-rater Agreement (Full Analysis Set)
Radiological finding class: Overall agreement (Conventional)
|
0.67 Proportion of participants
Interval 0.62 to 0.71
|
|
Inter-rater Agreement (Full Analysis Set)
Radiological finding class: Fleiss' kappa coefficient (Conventional)
|
0.48 Proportion of participants
Interval 0.43 to 0.54
|
|
Inter-rater Agreement (Full Analysis Set)
Radiological finding class: Gwet's AC1 coefficient (Conventional)
|
0.63 Proportion of participants
Interval 0.58 to 0.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Inter-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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Inter-method Agreement (Full Analysis Set)
Pathological finding: Overall agreement
|
0.86 Proportion of participants
Interval 0.83 to 0.88
|
|
Inter-method Agreement (Full Analysis Set)
Pathological finding: Fleiss' kappa coefficient
|
0.71 Proportion of participants
Interval 0.65 to 0.76
|
|
Inter-method Agreement (Full Analysis Set)
Pathological finding: Gwet's AC1 coefficient
|
0.72 Proportion of participants
Interval 0.67 to 0.77
|
|
Inter-method Agreement (Full Analysis Set)
Radiological finding class: Overall agreement
|
0.75 Proportion of participants
Interval 0.72 to 0.78
|
|
Inter-method Agreement (Full Analysis Set)
Radiological finding class: Fleiss' kappa coefficient
|
0.61 Proportion of participants
Interval 0.56 to 0.66
|
|
Inter-method Agreement (Full Analysis Set)
Radiological finding class: Gwet's AC1 coefficient
|
0.73 Proportion of participants
Interval 0.69 to 0.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 7-8Image 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Image Quality Score (Full Analysis Set)
T1w : Synthetic
|
4.6 score on a scale
Standard Deviation 0.6
|
|
Image Quality Score (Full Analysis Set)
T1w : Conventional
|
4.5 score on a scale
Standard Deviation 0.7
|
|
Image Quality Score (Full Analysis Set)
T2w : Synthetic
|
4.4 score on a scale
Standard Deviation 0.7
|
|
Image Quality Score (Full Analysis Set)
T2w : Conventional
|
4.2 score on a scale
Standard Deviation 0.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 Participants
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.
|
|---|---|
|
Safety (Full Analysis Set)
Adverse Events (AE)
|
0 events
|
|
Safety (Full Analysis Set)
Adverse Device Effects (ADE)
|
0 events
|
|
Safety (Full Analysis Set)
Serious Adverse Events (SAE)
|
0 events
|
|
Safety (Full Analysis Set)
Unanticipated Adverse Device Effect (UADE)
|
0 events
|
|
Safety (Full Analysis Set)
Unanticipated Serious Adverse Device Effect (USADE)
|
0 events
|
|
Safety (Full Analysis Set)
Device Deficiencies (DD)
|
1 events
|
Adverse Events
Neurologic Synthetic and Conventional MRI
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neurologic Synthetic and Conventional MRI
n=189 participants at risk
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.
|
|---|---|
|
Product Issues
Device Deficiencies
|
0.53%
1/189 • Number of events 1 • Exam day (1 day), Generation of Synthetic Images (up to 7 weeks)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place