Clinical trial NCT02596854: Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images
Official title: Comparative Study of Conventional 1.5 and 3.0T MR Images With Synthetically Reconstructed MR Images
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Indication for Brain MRI
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2015-11-04
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single group will be enrolled from the general imaging population using the scanner available at the investigational site (either 1.5T or 3.0T, based on site determination and not specified per protocol). All participants are assigned to a single group.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Diagnostic Image Quality Difference Between Conventional Versus Synthetic MR Utilizing a 5 Point Likert Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Grand Rapids
country: United States
facility: Advanced Radiology Services, PC/Spectrum Health
state: Michigan
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Cornell University
state: New York
city: New York
country: United States
facility: Manhattan Diagnostic Radiology (RadNet)
state: New York
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
References: