An interventional study of Neurological MRI in Clinical Indication for Brain MRI, sponsored by GE Healthcare. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-18.
Sponsored by GE Healthcare · Not applicable, Interventional, and Diagnostic
This study is being conducted for regulatory submission of the GE Healthcare MAGnetic resonance Image Compilation (MAGiC), a point-of-care synthetic MR reconstruction software for GE 1.5T and 3.0T MR scanners.
This study is a prospective, blinded, multi-center multi-reader (MCMR) clinical trial that is statistically powered for non-inferiority of diagnostic image quality of synthetic MR versus conventional MR and collection of supporting radiologic findings and morphology data from radiologists that reflect anticipated clinical usage of synthetic MR technology.
The study consists of three parts:
The study will enroll eligible adult subjects with clinical indications for brain MRI that meet applicable site MR safety criteria and are not pregnant. The study consists of one visit, the subject's MRI scan, without additional follow-up. Results are expected to be representative of expected clinical usage of synthetic MAGiC MR technology in clinical practice.
GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must:
Exclusion Criteria:
Subjects will be excluded that:
Images acquired for post processing with synthetic software. This is a crossover design where all subjects receive the same imaging scan, and comparison is done between the raw conventional scan and post-processed images using the research software.
Device: Neurological MRI
Neurological MRI image collection
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
Images were read by board-certified radiologists who reviewed each image and assessed it on a 5 Point scale (1=unacceptable, 2=poor image quality, 3=Acceptable, 4=Good, 5=Excellent) based on the quality of the image (eg, signal-to-noise, clarity of anatomic boundaries, and other parameters). The outcome was reported as the mean diagnostic image quality score difference (synthetic - conventional).
Time frame: 1 day
| Milestone | Neurological MRI |
|---|---|
| Started | 117 |
| Completed | 109 |
| Not completed | 8 |
| Withdrew: Withdrawn | 8 |
Images were read by board-certified radiologists who reviewed each image and assessed it on a 5 Point scale (1=unacceptable, 2=poor image quality, 3=Acceptable, 4=Good, 5=Excellent) based on the quality of the image (eg, signal-to-noise, clarity of anatomic boundaries, and other parameters). The outcome was reported as the mean diagnostic image quality score difference (synthetic - conventional).
| units on a 5-point scale | Neurological MRI |
|---|---|
| Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale | -0.335 ± 0.3522 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Neurological MRI | 0/117 (0%) | 0/117 (0%) | 2/117 (1.7%) |
| Event | Neurological MRI |
|---|---|
| Moderate ClaustrophobiaGeneral disorders | 1/117 |
| mild anxietyGeneral disorders | 1/117 |
The baseline is for all 117 participants, regardless of completion/withdrawal status. Patients were consented to allow information collected up until the time of withdrawal to remain on study to protect the integrity of the trial data.
| Age, Categorical(Participants) | Neurological MRI |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 107 |
| >=65 years | 10 |
| Age, Continuous(years) | Neurological MRI |
|---|---|
| Mean | 53.1 (19 to 89) |
| Sex: Female, Male(Participants) | Neurological MRI |
|---|---|
| Female | 67 |
| Male | 50 |
| Region of Enrollment(Participants) | Neurological MRI |
|---|---|
| United States | 117 |
| Static Field Strength of MRI Scans(Participants) | Neurological MRI |
|---|---|
| 1.5T Scans | 58 |
| 3.0T Scans | 59 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GE Healthcare