Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Wisconsin, Madison
Sponsor:
Collaborators:
Johns Hopkins University
Stanford University
University of Texas
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02025543
First received: December 12, 2013
Last updated: December 2, 2014
Last verified: December 2014
  Purpose

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 Intervention
Iron Overload
Hemochromatosis
Hemosiderosis
Other: MRI

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Confounder-Corrected Quantitative Magnetic Resonance Imaging (MRI) Biomarker of Hepatic Iron Content

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Primary Outcome Measure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Precision Outcome Measure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Repeat scans will be used at each site to determine precision of R2 liver iron concentration.

  • Accuracy Outcome Measure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    In addition to correlation with liver iron concentration (technical accuracy), the diagnostic accuracy through receiver operator characteristic curve analysis will also be determined.

  • Robustness Outcome Measure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    At each site and field strength, R2* measurements from the eight different protocols will be compared to assess robustness.


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patient
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
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with known or suspected iron overload

Criteria

Inclusion Criteria:

  • know or suspected iron overload

Exclusion Criteria:

  • contraindication to magnetic resonance imaging
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025543

Contacts
Contact: Scott Reeder, MD, PhD 608-265-9964 sreeder@uwhealth.org
Contact: Diego Hernando, PhD 608-265-7590 dhernando@uwhealth.org

Locations
United States, Wisconsin
University of Wisconsin, Madison Recruiting
Madison, Wisconsin, United States, 53705
Contact: Janice Yakey, RN    608-265-3018    jyakey@uwhealth.org   
Contact: Deborah Gawin, RN    608-265-8580    dgawin@uwhealth.org   
Principal Investigator: Scott Reeder, MD, PhD         
Sponsors and Collaborators
University of Wisconsin, Madison
Johns Hopkins University
Stanford University
University of Texas
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02025543     History of Changes
Other Study ID Numbers: 2013-1174
Study First Received: December 12, 2013
Last Updated: December 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
MRI
Iron overload

Additional relevant MeSH terms:
Hemochromatosis
Hemosiderosis
Iron Overload
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors

ClinicalTrials.gov processed this record on May 29, 2015