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N/A N=117 Diagnostic

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

Clinical Indication for Brain MRI

Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale — -0.335 units on a 5-point scale — p=<0.001

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Neurological MRI (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GE Healthcare
Primary completion
Jan 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
-0.335 <0.001 sig

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.

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02596854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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