Non-invasive Quantification of Liver Iron With MRI

Iron Overload Clinical Trial

Official title:

Non-invasive Quantification of Liver Iron With MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516853
• Other study ID #: 2011-0473
• Secondary ID: 2011-0473A539300
• Status: Completed
• Start date: January 2012
• Est. completion date: June 2015

Study information

• Verified date: December 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemosiderosis
• Iron Overload

Intervention

Device:
• Non-contrast MRI
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).

Locations

Country	Name	City	State
United States	Wisconsin Institutes for Medical Research	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hernando D, Cook RJ, Diamond C, Reeder SB. Magnetic susceptibility as a B0 field strength independent MRI biomarker of liver iron overload. Magn Reson Med. 2013 Sep;70(3):648-56. doi: 10.1002/mrm.24848. Epub 2013 Jun 25. — View Citation

Horng DE, Hernando D, Reeder SB. Quantification of liver fat in the presence of iron overload. J Magn Reson Imaging. 2017 Feb;45(2):428-439. doi: 10.1002/jmri.25382. Epub 2016 Jul 13. — View Citation

Sharma SD, Hernando D, Horng DE, Reeder SB. Quantitative susceptibility mapping in the abdomen as an imaging biomarker of hepatic iron overload. Magn Reson Med. 2015 Sep;74(3):673-83. doi: 10.1002/mrm.25448. Epub 2014 Sep 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Correlation of Ferritin and Liver R2*	Linear correlation between serum ferritin values and MRI R2* values	up to 1 day
Primary	Correlation of Ferritin and HIC Measured by FerriScan	Linear correlation between serum ferritin values and FerriScan hepatic iron measurement.	up to 1 day
Secondary	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