N/A
N=117
Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images
Clinical Indication for Brain MRI
Bottom Line
View on ClinicalTrials.gov: NCT02596854 ↗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
| Outcome | Result | p-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.
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.