NCT02425956

Non-invasive Quantification of Liver Iron With MRI

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Iron Overload

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-06-30
• Completion: 2016-06-30
• First posted: 2015-04-24
• Last updated: 2017-07-24
• Results posted: 2017-07-24

Locations

1 site across 1 country: United States