Brief Title
Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content
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 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.
Study Type
Observational
Primary Outcome
Calibration curve of liver R2* vs LIC measured by Ferriscan at each of the sites
Secondary Outcome
Precision: Difference in UW-measured R2* vs Average
Condition
Iron Overload
Intervention
MRI
Study Arms / Comparison Groups
Patient Group
Description: Subjects with known or suspected iron overload will undergo serum ferritin measurement and an MRI scan.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
222
Start Date
August 12, 2015
Completion Date
October 2022
Primary Completion Date
October 2022
Eligibility Criteria
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: - contraindication to magnetic resonance imaging
Gender
All
Ages
8 Years - 89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Scott Reeder, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02025543
Organization ID
2013-1174
Secondary IDs
A539300
Responsible Party
Sponsor
Study Sponsor
University of Wisconsin, Madison
Collaborators
Johns Hopkins University
Study Sponsor
Scott Reeder, Principal Investigator, University of Wisconsin, Madison
Verification Date
February 2022