Non-invasive Quantification of Liver Iron With MRI

Completed

• Conditions: Iron Overload; Hemosiderosis
• Interventions: Device: Non-contrast MRI

• Registration Number: NCT01516853
• Lead Sponsor: University of Wisconsin, Madison

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 Timeline

• Study First Submitted: 2011-08-17
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-25
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Non-contrast MRI	Subjects with no known history of iron overload or liver disease will undergo a serum iron measurement and a non-contrast MRI scan.
Patient Group	Non-contrast MRI	Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast MRI scan.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Variability of cardiac R2* with different imaging parameters	up to 1 day	Robustness of Proposed Method for Cardiac R2\* Estimation. Measure variability of cardiac R2\* with different imaging parameters.

Trial Locations

Locations (1)

Wisconsin Institutes for Medical Research; 🇺🇸 Madison, Wisconsin, United States