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Non-invasive Quantification of Liver Iron With MRI

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02425956
First Posted: April 24, 2015
Last Update Posted: July 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GE Healthcare
  Purpose
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.

Condition Intervention
Iron Overload Device: GE Optima/Discovery® MRI data of the liver

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Quantification of Liver Iron With MRI

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 21
Study Start Date: April 2015
Study Completion Date: June 30, 2016
Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • GE Optima/Discovery® MRI
  • FerriScan® (Resondence Health)
  • GE IDEAL IQ®

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
GE Healthcare
Investigators
Principal Investigator: Frank Korosec, PhD University of Wisconsin, Madison
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02425956     History of Changes
Other Study ID Numbers: 114-2014-GES-0039
First Submitted: March 16, 2015
First Posted: April 24, 2015
Results First Submitted: April 28, 2017
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Liver Extracts
Hematinics