Clinical Indication for Brain MRI
Conditions
Brief summary
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.
Detailed description
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: 1. Clinical MR acquisition, 2. synthetic MR post-processing at a GE facility, and 3. blinded image evaluation (BIE) of conventional and synthetic images for each subject. 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.
Interventions
DEVICENeurological MRI
Neurological MRI image collection
Sponsors
ICON plc
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
None used for this single group study.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must: 1. Be an adult 18 years of age or older; 2. Have clinical indication for MRI of the brain according to the site standard of care; 3. If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by a medically qualified investigator or demonstrated non-pregnant by negative urine pregnancy test; 4. Be able to hear and understand instructions without assistive devices; 5. Have necessary mental capacity to understand instructions be able to comply with protocol requirements; 6. Are able and willing to provide written informed consent by signing the informed consent form (ICF).
Exclusion criteria
Subjects will be excluded that: 1. Were previously enrolled in this evaluation; 2. Have metallic/conductive or electrically/magnetically active implants or attached medical devices (except for dental devices/fillings, surgical clips, and surgical staples) that could be unsafe for MRI; 3. Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site; 4. Have severe trauma or pre-existing pathology that is expected to interfere with normal conduct of MR scanning or complete scanning of the brain; 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale | 1 day | 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Neurological MRI Image acquired for post processing with synthetic software
Neurological MRI: Neurological MRI image collection | 117 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawn | 8 |
Baseline characteristics
| Characteristic | Neurological MRI |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 107 Participants |
| Age, Continuous | 53.1 years |
| Region of Enrollment United States | 117 Participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 50 Participants |
| Static Field Strength of MRI Scans 1.5T Scans | 58 Participants |
| Static Field Strength of MRI Scans 3.0T Scans | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 117 |
| other Total, other adverse events | 2 / 117 |
| serious Total, serious adverse events | 0 / 117 |
Outcome results
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).
Time frame: 1 day
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neurological MRI | Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale | -0.335 units on a 5-point scale | Standard Deviation 0.3522 |
Comparison: Non-inferiority of synthetic MR versus conventional commercial MR the hypothesis can be stated as H0: S ≤ -Δ and HA: S \> -Δ.p-value: <0.00195% CI: [-0.428, -0.269]Wilcoxon (Mann-Whitney)