Non-invasive Quantification of Liver Iron With MRI
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Purpose
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 Hemosiderosis |
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 |
- 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) |
-
Device: Non-contrast MRI
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.
Eligibility| 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| Contact: Scott B Reeder, MD, PhD | 608-265-9964 | sreeder@uwhealth.org |
| United States, Wisconsin | |
| Wisconsin Institutes for Medical Research | Recruiting |
| Madison, Wisconsin, United States, 53705 | |
| Contact: Diego Hernando, PhD 608-265-7590 dhernando@wisc.edu | |
| Sub-Investigator: Diego Hernando, PhD | |
| Principal Investigator: Scott B Reeder, MD, PhD | |
| Principal Investigator: | Scott B Reeder, MD, PhD | University of Wisconsin, Madison |
More Information
No publications provided
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov 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 |
Additional relevant MeSH terms:
|
Hemosiderosis Iron Overload Iron Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013