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

Completed · Not applicable

Conditions studied: Clinical Indication for Brain MRI

In brief

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.

Key facts

Study ID

NCT02596854

Run by

GE Healthcare

People needed

117

Starts

2015-11-01

Expected to finish

2016-04-01

Last updated by the study team

2018-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must:
• Be an adult 18 years of age or older;
• Have clinical indication for MRI of the brain according to the site standard of care;
• 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;
• Be able to hear and understand instructions without assistive devices;
• Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
• Are able and willing to provide written informed consent by signing the informed consent form (ICF).

You may not qualify if…

• Subjects will be excluded that:
• Were previously enrolled in this evaluation;
• 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;
• Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
• Have severe trauma or pre-existing pathology that is expected to interfere with normal conduct of MR scanning or complete scanning of the brain;
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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