Non-invasive Quantification of Liver Iron With MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Calibration Curve of Liver R2* vs. HIC Measured by FerriScan
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Calibration Curve of Liver R2* vs. HIC Measured by FerriScan
Time Frame: Up to 1 day
Accuracy of non-contrast R2\*-MRI for measuring hepatic iron concentration.
Correlation of Ferritin and Liver R2*
Time Frame: up to 1 day
Linear correlation between serum ferritin values and MRI R2\* values
Correlation of Ferritin and HIC Measured by FerriScan
Time Frame: up to 1 day
Linear correlation between serum ferritin values and FerriScan hepatic iron measurement.
Secondary Outcomes
- Variability of cardiac R2* with different imaging parameters(up to 1 day)