Non-invasive Quantification of Liver Iron With MRI
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|ClinicalTrials.gov Identifier: NCT02425956|
Recruitment Status : Completed
First Posted : April 24, 2015
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Iron Overload||Device: GE Optima/Discovery® MRI data of the liver||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Quantification of Liver Iron With MRI|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||June 30, 2016|
Experimental: MRI imaging of liver
GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®
Device: GE Optima/Discovery® MRI data of the liver
GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer
- Per Subject Evaluable DICOM Data Sets From Liver MRI [ Time Frame: 48 hours pre or 24 hours post blood draw ]The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.
- Serum Ferritin Based on Blood Draw [ Time Frame: 48 hours post MR scan or 24 hours pre MR scan ]The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425956
|United States, Wisconsin|
|University of Wisconsin-Madison|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Frank Korosec, PhD||University of Wisconsin, Madison|