Non-invasive Quantification of Liver Iron With MRI

Brief Title

Non-invasive Quantification of Liver Iron With MRI

Official Title

Non-invasive Quantification of Liver Iron With MRI

Brief Summary

      The purpose of this study is to validate magnetic resonance imaging as a biomarker of hepatic
      iron concentration (HIC). Excessive accumulation of iron in the body is highly toxic,
      specifically in the liver. Accurate, non-invasive assessment of HIC is needed for diagnosis,
      quantitative staging and treatment monitoring or hepatic iron overload.
    

Detailed Description

      Excessive accumulation of iron in the body can result from abnormal intestinal absorption in
      hereditary hemochromatosis or repeated intravenous blood transfusions (ie: transfusional
      hemosiderosis). Excess body iron is highly toxic, and requires treatment aimed at reducing
      body iron stores. Measurement of body iron stores is critical for detection of iron overload,
      staging its severity and monitoring of iron-reducing therapies that are often extremely
      expensive (>$40,000/year) and carry their own toxicities. MRI has been shown to be very
      sensitive to the presence of iron. The investigators have developed an MRI-based method for
      rapid iron quantification (for instance, whole liver in a single breath-hold). The purpose of
      this work is to validate this new method using the FDA-approved Ferriscan technique
      (Resonance Health, Claremont, Australia) as a reference standard.
    

Study Type

Observational

Primary Outcome

Calibration Curve of Liver R2* vs. HIC Measured by FerriScan

Secondary Outcome

 Variability of cardiac R2* with different imaging parameters

Condition

Iron Overload

Intervention

Non-contrast MRI

Study Arms / Comparison Groups

 Patient Group

Description:  Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast 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 Status

Device

Estimated Enrollment

50

Start Date

January 2012

Completion Date

June 2015

Primary Completion Date

June 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Controls: 18 years or older with no known history of iron overload or liver disease.

          -  Patients: 10 years or older with known or suspected iron overload

        Exclusion Criteria:

          -  Patients with contraindications to MRI (eg. pacemaker, contraindicated metallic
             implants, claustrophobia, etc) and pregnant females (as determined by self-report
             during MRI safety screening) will be excluded.

          -  For control subjects, those with known liver disease will be excluded.
      

Gender

All

Ages

10 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Scott B Reeder, MD, PhD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01516853

Organization ID

2011-0473

Secondary IDs

2011-0473

Responsible Party

Sponsor

Study Sponsor

University of Wisconsin, Madison

Study Sponsor

Scott B Reeder, MD, PhD, Principal Investigator, University of Wisconsin, Madison

Verification Date

December 2019