Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

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.

Inclusion Criteria:

- know or suspected iron overload

Exclusion Criteria:

- contraindication to magnetic resonance imaging