Non-invasive Quantification of Liver Iron With MRI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-invasive Quantification of Liver Iron With MRI

Conditions
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Iron Overload, Hemosiderosis

Intervention / Treatment
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* Device: Non-contrast MRI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Group<br>Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast MRI scan. | Device: Non-contrast MRI<br>* Non-contrast MRI will be performed on each subject, at both 1.5T and 3.0T. Different MRI sequences (spin-echo and gradient-echo) will be used, with varying acquisition parameters (e.g., echo times, spatial resolution).<br>|
| Control Group<br>Subjects with no known history of iron overload or liver disease will undergo a serum iron measurement and a non-contrast MRI scan. | Device: Non-contrast MRI<br>* Non-contrast MRI will be performed on each subject, at both 1.5T and 3.0T. Different MRI sequences (spin-echo and gradient-echo) will be used, with varying acquisition parameters (e.g., echo times, spatial resolution).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calibration Curve of Liver R2* vs. HIC Measured by FerriScan | Accuracy of non-contrast R2*-MRI for measuring hepatic iron concentration. | Up to 1 day | 
| Correlation of Ferritin and Liver R2* | Linear correlation between serum ferritin values and MRI R2* values | up to 1 day | 
| Correlation of Ferritin and HIC Measured by FerriScan | Linear correlation between serum ferritin values and FerriScan hepatic iron measurement. | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of cardiac R2* with different imaging parameters | Robustness of Proposed Method for Cardiac R2* Estimation. Measure variability of cardiac R2* with different imaging parameters. | up to 1 day |