Trial record 11 of 15 for:    Open Studies | "Hemochromatosis"

Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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 27, 2013
Last verified: December 2013
  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
Other: MRI
R2 MRI scan
Other Name: Magnetic Resonance Imaging
Control
Subjects with no known history of iron overload or liver disease
Other: MRI
R2 MRI scan
Other Name: Magnetic Resonance Imaging

  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

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 27, 2013
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
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014