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

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.

Study Overview

• Status: Completed
• Conditions: Clinical Indication for Brain MRI
• Intervention / Treatment: Device: Neurological MRI

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Advanced Radiology Services, PC/Spectrum Health
  • New York
    • New York, New York, United States, 10065
      • Cornell University
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
    • New York, New York, United States, 10065
      • Manhattan Diagnostic Radiology (RadNet)
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin-Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Neurological MRI image collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: ICON plc

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 4, 2015

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 114-2015-GES-0056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO