Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

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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