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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurological MRI | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurological MRI | Device | Neurological MRI image collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 day |
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Inclusion Criteria:
Subjects must:
Exclusion Criteria:
Subjects will be excluded that:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| Advanced Radiology Services, PC/Spectrum Health |
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A single arm of subjects was enrolled and analyzed. Scanner selection (1.5T or 3.0T) was based on availability at the site and assigned by the site. Only one arm assignment (neurological MRI population) was per-protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neurological MRI | Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Neurological MRI | Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Clinical indication for MRI of the brain based on site standard of care. This is a crossover study design where all subjects are enrolled into a single group producing two data types. The hypothesis test is a function of conventional and post-processed image quality within this patient group (one value summarized for this single population). | Posted | Mean | Standard Deviation | units on a 5-point scale | 1 day |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neurological MRI | Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate Claustrophobia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Strohmeyer | GE Healthcare | 609-865-7423 | john.strohmeyer@ge.com |
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A single group will be enrolled from the general imaging population using the scanner available at the investigational site (either 1.5T or 3.0T, based on site determination and not specified per protocol). All participants are assigned to a single group.
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None used for this single group study.
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| Grand Rapids |
| Michigan |
| 49525 |
| United States |
| The Mount Sinai Hospital | New York | New York | 10029 | United States |
| Cornell University | New York | New York | 10065 | United States |
| Manhattan Diagnostic Radiology (RadNet) | New York | New York | 10065 | United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Static Field Strength of MRI Scans | Count of Participants | Participants |
|
Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection |
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| 2 |
| 117 |
| mild anxiety | General disorders | anxiety | Systematic Assessment | anxiety |
|
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