Clinical Trial: Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Confounder-Corrected Quantitative Magnetic Resonance Imaging (MRI) Biomarker of Hepatic Iron Content

Brief Summary: The purpose of this multi-site research is to validate a rapid magnetic resonance based confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron concentrations.

Detailed Summary: This multi-center, multi-vendor study will validate a rapid magnetic resonance-based confounder-corrected R2* mapping method as a quantitative imaging biomarker of liver iron concentration (LIC). Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Measurement of LIC is critical for detection and staging of iron overload, and for monitoring iron-reducing chelator therapies that are expensive and have side effects. Magnetic Resonance Imaging (MRI) is a widely available, accessible, and safe technology, and it is very sensitive to the presence of iron in tissue. Translation of an MRI biomarker of liver iron concentration into broad clinical use requires that it is clinically feasible, precise, robust to changes in scan parameters, calibrated to a validated reference standard of LIC, and is reproducible across sites and manufacturers. There are currently no available MRI methods that meet these requirements. R2*-MRI holds the greatest promise to meet these requirements. R2* mapping can be performed very rapidly with whole-liver 3D coverage in a single 20s breath-hold.
Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Primary Outcome Measure [ Time Frame: 1 year ]

We expect to demonstrate equivalence between R2 measured with different protocols with higher repeatability than standard MRI iron imaging measurement and with linear calibration to liver iron concentration . This project will be considered a success if we establish the reproducibility of confounder-corrected R2 MRI: we expect the calibrations at all sites to be equivalent.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Precision Outcome Measure [ Time Frame: 2 years ]
    Repeat scans will be used at each site to determine precision of R2 liver iron concentration.
  • Accuracy Outcome Measure [ Time Frame: 2 years ]
    In addition to correlation with liver iron concentration (technical accuracy), the diagnostic accuracy through receiver operator characteristic curve analysis will also be determined.
  • Robustness Outcome Measure [ Time Frame: 2 years ]
    At each site and field strength, R2* measurements from the eight different protocols will be compared to assess robustness.


Original Secondary Outcome: Same as current

Information By: University of Wisconsin, Madison

Dates:
Date Received: December 12, 2013
Date Started: December 2013
Date Completion: December 2018
Last Updated: March 13, 2017
Last Verified: March 2017