Clinical trial NCT01516853: Non-invasive Quantification of Liver Iron With MRI
Official title: Non-invasive Quantification of Liver Iron With MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Iron Overload
Hemosiderosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Calibration Curve of Liver R2* vs. HIC Measured by FerriScan
timeFrame: Up to 1 day
measure: Correlation of Ferritin and Liver R2*
timeFrame: up to 1 day
measure: Correlation of Ferritin and HIC Measured by FerriScan
timeFrame: up to 1 day
Secondary outcomes:
measure: Variability of cardiac R2* with different imaging parameters
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Madison
country: United States
facility: Wisconsin Institutes for Medical Research
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Scott B Reeder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.