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Completed

NCT Number: NCT01516853

Non-invasive Quantification of Liver Iron With MRI

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wisconsin Institutes for Medical Research

Madison, Wisconsin, 53705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-contrast MRI

Device

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).

Primary outcomes

  1. 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.

  2. Correlation of Ferritin and Liver R2*

    Time frame: up to 1 day

    Linear correlation between serum ferritin values and MRI R2* values

  3. 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

  1. Variability of cardiac R2* with different imaging parameters

    Time frame: up to 1 day

    Robustness of Proposed Method for Cardiac R2* Estimation. Measure variability of cardiac R2* with different imaging parameters.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 25, 2012
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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