NCT02596854

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clinical Indication for Brain MRI

Interventions

Type	Name	Description
DEVICE	Neurological MRI	Neurological MRI image collection

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-01-01
• Completion: 2016-04-01
• First posted: 2015-11-04
• Last updated: 2018-06-18
• Results posted: 2017-11-06

Locations

6 sites across 1 country: United States