About this trial
The purpose of this research is to see if a new automated magnetic resonance imaging (MRI) method will be able to improve the images taken of the liver. Participants will have either known or suspected liver disease, known or suspected iron overload syndrome, or be a healthy adult. Participants will be in the research study for one day.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Disqualifiers
Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
Age 7 years or older
Known or suspected liver iron overload
Trial population
Healthy volunteers will be recruited from the "MRI Volunteer Database", and/or UW - Madison employees. Participants with liver fat or liver iron will be recruited from relevant UW Clinics.
Trial design
Cohort
Prospective
Treatments tested in this trial
Non-contrast MRI with novel MRI software
DeviceThe investigational software being used in automatic prescription of the imaging is an application of an AI algorithm. This software prescribes where the MRI system will take images by finding the liver within a set of localizer scans. The software gives coordinates to the scanner.
Treatment groups
Trial outcomes
Primary outcomes
Confirm the accuracy (ie: bias) of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload
For each liver segment, and for whole-liver PDFF and R2\* measurements, we will determine bias of CSE 2D using CSE 3D BH as the reference from Bland-Altman analysis. The range of R2\* values leading to reliable measurements of PDFF and R2\* will be determined using a two-segment piecewise linear model with the change point estimated from the data.
Secondary outcomes
Image quality of free breathing 2D chemical shift encoded (CSE) method
Image quality for each acquisition will be evaluated by 3 radiologists, using a Likert scale between 0 (worst/non-diagnostic) and 3 (best) for criteria including: motion artifacts, spatial resolution, SNR (signal- to-noise ratio), and overall image quality.
Measure the repeatability of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload
To compare repeatability for various acquisition/reconstruction methods, we will calculate the squared difference between each pair of repeated PDFF / R2\* measurements, and will model this value including the acquisition/reconstruction method as a covariate using Generalized Estimating Equations (GEE), with subject as a random factor to account for within-subject correlation. This analysis will be performed for all liver segments and whole-liver measurements. Further, the repeatability coefficient will also be assessed separately for each method. Bland-Altman plots will also be used to visualize the repeatability profile over the PDFF / R2\* range. The automated vs manual PDFF / R2\* measurements will be evaluated for each acquisition.
Confirm the reproducibility of the proposed CSE-MRI method across field strengths
The reproducibility of the proposed method between 1.5T and 3T will be evaluated in two ways. First, at each field strength, PDFF and R2\* will each be compared between FB FAM CSE and BH CSE 3D (as the reference), using Bland Altman analysis to assess the bias. Second, PDFF will be compared between 1.5T and 3T using Bland Altman analysis for each method, based on the expected field strength independence of PDFF. R2\* will also be compared between 1.5T and 3T for each method, after converting to liver iron concentration (LIC, mg/g) using the 1.5T and 3T calibrations determined by our group, to compensate for the effect of field strength on R2\*. In all comparisons, the reproducibility coefficient, and interclass correlation coefficient (ICC) with 95% confidence intervals will be calculated to quantify the degree of reproducibility.
Technical success rate of the integrated single-button push, fully automated CSE-MRI protocol in < 5 minutes of MR room time
The technical success rate of the integrated single-button push, fully automated CSE-MRI exam will be determined through completion rate of the exam in less than 5 minutes, radiologist evaluation of image quality using a Likert scale, and accuracy of the automated analysis compared to manual evaluation.
Sponsors and contacts
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University of Wisconsin, Madison
Lead sponsor
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Collaborator