CClinicalTrials.gg
CompletedNCT02596854Updated Jun 18, 2018Results posted

Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images

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

Phase
Not applicable
Study type
Interventional
Enrollment
117
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Clinical Indication for Brain MRI
03

In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
117 participants (actual)

Study arms

  • Experimental
    Neurological MRI

    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

Interventions

  • DeviceNeurological MRI

    Neurological MRI image collection

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What researchers measure

Primary outcomes

  1. 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

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Results

Posted Nov 6, 2017

Participant flow

Participant flow — Overall Study
MilestoneNeurological MRI
Started117
Completed109
Not completed8
Withdrew: Withdrawn8

Outcome measures

PrimaryMean 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
Reported as:
Mean · units on a 5-point scale
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
units on a 5-point scaleNeurological MRI
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale-0.335 ± 0.3522
Statistical analysis
  • Neurological MRI · Wilcoxon (Mann-Whitney) · p = <0.001 (No adjustments were made for multiple comparisons.) · Median difference (net): -0.428 · 95% CI -0.428 to -0.269Notably, no separate comparative statistical analysis was performed for the 1.5T and 3.0T subgroups, which were pooled for analysis. All patients underwent both synthetic MR and commercial conventional MR in a single arm.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Neurological MRI0/117 (0%)0/117 (0%)2/117 (1.7%)
Most frequent other events
Most frequent other events
EventNeurological MRI
Moderate ClaustrophobiaGeneral disorders1/117
mild anxietyGeneral disorders1/117

Baseline characteristics

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
Age, Categorical(Participants)Neurological MRI
<=18 years0
Between 18 and 65 years107
>=65 years10
Age, Continuous
Age, Continuous(years)Neurological MRI
Mean53.1 (19 to 89)
Sex: Female, Male
Sex: Female, Male(Participants)Neurological MRI
Female67
Male50
Region of Enrollment
Region of Enrollment(Participants)Neurological MRI
United States117
Static Field Strength of MRI Scans
Static Field Strength of MRI Scans(Participants)Neurological MRI
1.5T Scans58
3.0T Scans59
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Study locations

6 sites
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Advanced Radiology Services, PC/Spectrum Health
    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
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02596854
Lead sponsor
GE Healthcare
Collaborators
ICON plc
Responsible party
Sponsor
First posted
Nov 4, 2015
Start date
Nov 2015
Primary completion
Jan 2016
Completion
Apr 2016
Results posted
Nov 6, 2017
Last update
Jun 18, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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