Non-invasive Quantification of Liver Iron With MRI

University of Wisconsin (UW)

Status: Completed

Conditions: Hemosiderosis; Iron Overload

Treatments: Device: Non-contrast MRI

Study type: Observational

Funder types: Other

Identifiers

NCT01516853

A539300 (Other Identifier)

2011-0473 (Other Identifier)

SMPH\RADIOLOGY\RADIOLOGY (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

Patient Group

Description:

Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast MRI scan.

Treatment:

Device: Non-contrast MRI

Control Group

Description:

Subjects with no known history of iron overload or liver disease will undergo a serum iron measurement and a non-contrast MRI scan.

Treatment:

Device: Non-contrast MRI