Non-invasive Quantification of Liver Iron With MRI



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:10 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:February 2017
Contact:Frank Korosec, PhD
Email:FKorosec@uwhealth.org
Phone:608-265-5588

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This study is being conducted to build a library of prospectively collected clinical data
from subjects with iron overload examined with commercially available MRI devices. This data
library is intended for use in future engineering development and other research activities,
including future regulatory submissions. Data from human subjects is required to develop and
test Magnetic resonance (MR) reconstruction techniques that can provide quantitative
information about tissue properties, such as volumetric fat and iron concentrations.
Collection of MR data and corresponding quantitative liver iron concentration (LIC) data is
necessary for development of MR techniques that can show both overall and regional iron
concentrations of in vivo tissues. These techniques may provide viable alternatives to
invasive and expensive conventional liver biopsy and to less accurate serum biomarker
testing, potentially benefiting future clinical patients with iron overload.

MR image data and corresponding quantitative data about serum and liver iron levels will be
collected from each subject in this study. These datasets are considered suitable for future
development and testing of MR reconstruction software, including MR reconstruction
algorithms developed by General Electric Healthcare (GEHC) to use Longitudinal relaxation
rate equal to the reciprocal of T2 relaxation time (1/T2) (R2) techniques to assess LIC. To
achieve a sufficiently diverse library for future testing, MRI data of the liver and
surrounding tissues will be acquired using 1.5T and 3.0T GEHC IDEAL IQ scans and
commercially available 1.5T MRI scans conducted according to the FerriScan® Specialized
Reconstruction Service guidelines (Resonance Health, Claremont, AU). Quantitative
hematologic (serum ferritin) based on blood testing and FerriScan® Analysis Service LIC
reports will be collected for each subject.


Inclusion Criteria

1. Be at least ten (10) years of age;

2. Have clinical history of iron overload;

3. If female of childbearing potential (not surgically sterile or post-menopausal), be
determined non-pregnant by the medical co-investigator and/or a delegated physician
on the study staff or are demonstrated non-pregnant by negative urine pregnancy test
administered within the 24 hour period before participating in study procedures;

4. Provide evidence of willingness to participate by providing written informed consent
to participate OR, if aged less than 18 years (<18) be willing to provide written
assent to participate and have parent(s) or legal guardian(s) willing to provide
written informed consent for the subject's participation;

5. Be able to hear and understand instructions without assistive devices;

6. Have necessary mental capacity to understand instructions be able to comply with
protocol requirements;

7. Be able to remain relatively motionless for the expected duration of imaging
procedures (maximum of approximately 90 minutes).

Exclusion Criteria

1. Have medical history of present or prior focal liver disease, such as neoplasms or
vascular abnormalities;

2. Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy
of the investigational site;

3. Are scheduled for surgery, changes in dosage or type of chelating medications, or
other medical interventions in between blood draw and MRI scanning that could be
expected to impact study results or conduct;

4. Have had or plan to have a change in dosage or type of chelating medications (such as
Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure
(blood draw or MRI, whichever comes first);

5. Are minor subjects with parent(s) or legal guardian(s) that require that they
accompany the subject into the MR environment;

6. Have previously participated in this study.
We found this trial at
1
site
Madison, Wisconsin 53706
(608) 263-2400
Phone: 608-265-5588
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