Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

University of Wisconsin (UW)

Status

Completed

Conditions

Hemosiderosis

Hemochromatosis

Iron Overload

Treatments

Device: MRI

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02025543

2013-1174

Protocol Version 12/12/22 (Other Identifier)

SMPH/RADIOLOGY/RADIOLOGY* (Other Identifier)

A539300 (Other Identifier)

R01DK100651 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Protocol Modification approved to include additional liver susceptibility measurements for approximately 10 participants (already enrolled at the UW) via recently acquired Superconducting Quantum Interference Device (SQUID). The completion of this additional imaging will depend upon the successful set up and installation of this device.

Per a protocol amendment approved on 10/11/21, the investigators are re-opening the study and increasing enrollment for control subjects. Up to 20 control subjects (changed from 5) will be enrolled.

Enrollment

207 patients

Sex

All

Ages

8 to 89 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

know or suspected iron overload
minimum age: Stanford- 8years , University of Wisconsin - 10 years, John Hopkins follow- 10 years, University of Texas-Southwestern - 18 years

Exclusion criteria