An observational study in Iron Overload and Hemosiderosis, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-06.
Sponsored by University of Wisconsin, Madison · Observational
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.
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.
168 studies on the registry are indexed under Iron Overload; 8 are open to participants now.
This study's enrollment of 50 is below the median of 80 across 50 observational studies indexed under Iron Overload.
Browse Iron Overload studies →University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with known or suspected iron overload are identified and recruited in 3 different ways, 1) referral from the Division of Hematology/Oncology and Pediatric Hematology/Oncology, 2) via clinical reading of abdominal MRIs for evidence of iron overload, and 3) participants identified to have serum ferritin levels >500 by UW Hospital Clinical Laboratory will be invited to participant. Controls were recruited from a recruitment database.
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Exclusion Criteria:
Subjects with known or suspected iron overload will undergo serum iron measurements and a non-contrast MRI scan.
Device: Non-contrast MRI
Subjects with no known history of iron overload or liver disease will undergo a serum iron measurement and a non-contrast MRI scan.
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).
Calibration Curve of Liver R2* vs. HIC Measured by FerriScan
Accuracy of non-contrast R2\*-MRI for measuring hepatic iron concentration.
Time frame: Up to 1 day
Correlation of Ferritin and Liver R2*
Linear correlation between serum ferritin values and MRI R2\* values
Time frame: up to 1 day
Correlation of Ferritin and HIC Measured by FerriScan
Linear correlation between serum ferritin values and FerriScan hepatic iron measurement.
Time frame: up to 1 day
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.
Time frame: up to 1 day
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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