Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Non-invasive Quantification of Liver Iron With MRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Wisconsin, Madison.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: August 17, 2011
Last updated: January 19, 2012
Last verified: January 2012

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.

Condition Intervention
Iron Overload
Device: Non-contrast MRI

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Non-invasive Quantification of Liver Iron With MRI

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Accuracy and robustness of non-contrast R2*-MRI for measuring hepatic iron concentration [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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).
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.


Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01516853

Contact: Scott B Reeder, MD, PhD 608-265-9964

United States, Wisconsin
Wisconsin Institutes for Medical Research Recruiting
Madison, Wisconsin, United States, 53705
Contact: Diego Hernando, PhD    608-265-7590   
Sub-Investigator: Diego Hernando, PhD         
Principal Investigator: Scott B Reeder, MD, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Scott B Reeder, MD, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison Identifier: NCT01516853     History of Changes
Other Study ID Numbers: 2011-0473
Study First Received: August 17, 2011
Last Updated: January 19, 2012
Health Authority: United States: Institutional Review Board processed this record on March 03, 2015