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 Information
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
Administrative Informations
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