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Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02025543
Recruitment Status : Recruiting
First Posted : January 1, 2014
Last Update Posted : January 29, 2019
Johns Hopkins University
Stanford University
University of Texas
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
The purpose of this multi-site research is to validate a rapid magnetic resonance based confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron concentrations.

Condition or disease Intervention/treatment Phase
Iron Overload Hemochromatosis Hemosiderosis Other: MRI Not Applicable

Detailed Description:
This multi-center, multi-vendor study will validate a rapid magnetic resonance-based confounder-corrected R2* mapping method as a quantitative imaging biomarker of liver iron concentration (LIC). Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Measurement of LIC is critical for detection and staging of iron overload, and for monitoring iron-reducing chelator therapies that are expensive and have side effects. Magnetic Resonance Imaging (MRI) is a widely available, accessible, and safe technology, and it is very sensitive to the presence of iron in tissue. Translation of an MRI biomarker of liver iron concentration into broad clinical use requires that it is clinically feasible, precise, robust to changes in scan parameters, calibrated to a validated reference standard of LIC, and is reproducible across sites and manufacturers. There are currently no available MRI methods that meet these requirements. R2*-MRI holds the greatest promise to meet these requirements. R2* mapping can be performed very rapidly with whole-liver 3D coverage in a single 20s breath-hold.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Confounder-Corrected Quantitative Magnetic Resonance Imaging (MRI) Biomarker of Hepatic Iron Content
Study Start Date : December 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Patient Group
Subjects with known or suspected iron overload will undergo serum ferritin measurement and an MRI scan.
Other: MRI
R2 MRI scan
Other Name: Magnetic Resonance Imaging

Control Group
Subjects with no known history of iron overload or liver disease will undergo an MRI scan.
Other: MRI
R2 MRI scan
Other Name: Magnetic Resonance Imaging

Primary Outcome Measures :
  1. Primary Outcome Measure [ Time Frame: 1 year ]
    We expect to demonstrate equivalence between R2 measured with different protocols with higher repeatability than standard MRI iron imaging measurement and with linear calibration to liver iron concentration . This project will be considered a success if we establish the reproducibility of confounder-corrected R2 MRI: we expect the calibrations at all sites to be equivalent.

Secondary Outcome Measures :
  1. Precision Outcome Measure [ Time Frame: 2 years ]
    Repeat scans will be used at each site to determine precision of R2 liver iron concentration.

  2. Accuracy Outcome Measure [ Time Frame: 2 years ]
    In addition to correlation with liver iron concentration (technical accuracy), the diagnostic accuracy through receiver operator characteristic curve analysis will also be determined.

  3. Robustness Outcome Measure [ Time Frame: 2 years ]
    At each site and field strength, R2* measurements from the eight different protocols will be compared to assess robustness.

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • know or suspected iron overload

Exclusion Criteria:

  • contraindication to magnetic resonance imaging

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 identifier (NCT number): NCT02025543

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Contact: Scott Reeder, MD, PhD 608-265-9964
Contact: Diego Hernando, PhD 608-265-7590

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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94087
Contact: Elisabeth Merkel, RN    650-736-0644   
Principal Investigator: Shryas Vasanawala, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Veronica Quirk    410-614-1608   
Principal Investigator: Ihab Kamel, MD         
United States, Texas
University of Texas-Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Kelli Key    214-648-8152   
Contact: Michael Fulkerson    214-648-5984   
Principal Investigator: Ivan Pedrosa, MD         
United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53704
Contact: Gemma Gliori, MS    608-262-7269   
Contact: Suzanne Hanson, BS    608-263-7421   
Principal Investigator: Scott Reeder, MD, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Johns Hopkins University
Stanford University
University of Texas

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Responsible Party: University of Wisconsin, Madison Identifier: NCT02025543     History of Changes
Other Study ID Numbers: 2013-1174
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Case report forms will be coded with a unique study identification number and sent to with the coordinating center by courier. Images will be shared shared using secure FTP server.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Wisconsin, Madison:
Iron overload

Additional relevant MeSH terms:
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Iron Overload
Iron Metabolism Disorders
Metabolic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Trace Elements
Growth Substances
Physiological Effects of Drugs