Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content

NCT02025543 | Completed FDA Device

• 5 other identifiers: 2013-1174A539300SMPH/RADIOLOGY/RADIOLOGY*R01DK100651Protocol Version 12/12/22
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 4

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.

Conditions

Iron Overload; Hemochromatosis; Hemosiderosis

Keywords

MRI; Iron overload

Outcome Measures

Primary Outcomes (1)

• Calibration curve of liver R2* vs LIC measured by Ferriscan at each of the sites

  The hypothesis is that equivalence between R2 measured with different protocols with higher repeatability than standard MRI iron imaging measurement and with linear calibration to liver iron concentration will be demonstrated. This project will be considered a success if the reproducibility of confounder-corrected R2 MRI is established: the hypothesis is that calibrations at all sites will be equivalent.

  1 year

Secondary Outcomes (3)

• Precision: Difference in UW-measured R2* vs Average

  2 years

• Diagnostic Accuracy

  2 years

• Robustness Assessed via Linear Mixed Effects Regression

  2 years

Study Arms (2)

Patient Group

Subjects with known or suspected iron overload will undergo serum ferritin measurement and an MRI scan.

Device: MRI

Control Group

Subjects with no known history of iron overload or liver disease will undergo an MRI scan.

Device: MRI

Interventions

MRI DEVICE

R2 MRI scan

Also known as: Magnetic Resonance Imaging

Control Group; Patient Group

Eligibility Criteria

• Age: 8 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with known or suspected iron overload, plus a control cohort

You may qualify if:

• know or suspected iron overload
• minimum age: Stanford- 8years , University of Wisconsin - 10 years, John Hopkins follow- 10 years, University of Texas-Southwestern - 18 years

You may not qualify if:

• contraindication to magnetic resonance imaging

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Johns Hopkins University: collaborator
• Stanford University: collaborator
• University of Texas: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (4)

Stanford University

Palo Alto, California, 94087, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

University of Texas-Southwestern

Dallas, Texas, 75390, United States

Location

University of Wisconsin, Madison

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• Hernando D, Zhao R, Yuan Q, Aliyari Ghasabeh M, Ruschke S, Miao X, Karampinos DC, Mao L, Harris DT, Mattison RJ, Jeng MR, Pedrosa I, Kamel IR, Vasanawala S, Yokoo T, Reeder SB. Multicenter Reproducibility of Liver Iron Quantification with 1.5-T and 3.0-T MRI. Radiology. 2023 Feb;306(2):e213256. doi: 10.1148/radiol.213256. Epub 2022 Oct 4.

  PMID: 36194113 RESULT

MeSH Terms

Conditions

Iron Overload; Hemochromatosis; Hemosiderosis

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Metal Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Scott Reeder

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: January 1, 2014
• Study Start: August 12, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (4)