Trial Outcomes & Findings for Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images (NCT NCT02596854)

Last Updated: 2018-06-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

117 participants

Primary outcome timeframe

1 day

Results posted on

2018-06-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Neurological MRI Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection
Overall Study STARTED	117
Overall Study COMPLETED	109
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Neurological MRI Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection
Overall Study Withdrawn	8

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Neurological MRI n=117 Participants Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	107 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	53.1 years n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Region of Enrollment United States	117 Participants n=5 Participants
Static Field Strength of MRI Scans 1.5T Scans	58 Participants n=5 Participants
Static Field Strength of MRI Scans 3.0T Scans	59 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Neurological MRI n=109 Participants Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection
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

Adverse Events

Neurological MRI

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Neurological MRI n=117 participants at risk Image acquired for post processing with synthetic software Neurological MRI: Neurological MRI image collection
General disorders Moderate Claustrophobia	0.85% 1/117 • Number of events 1
General disorders mild anxiety	0.85% 1/117 • Number of events 1

Additional Information

John Strohmeyer

GE Healthcare

Phone: 609-865-7423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place