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MRI QSM Imaging for Iron Overload

University of Wisconsin (UW) logo

University of Wisconsin (UW)

Status

Completed

Conditions

Hemochromatosis
Iron Overload

Treatments

Radiation: Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04631718
1R01DK117354-01 (U.S. NIH Grant/Contract)
2020-0761
Protocol Version 9/10/2021 (Other Identifier)
SMPH/RADIOLOGY/RADIOLOGY (Other Identifier)
A539300 (Other Identifier)

Details and patient eligibility

About

The overall goal of this project is to develop and validate a novel technique for Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM) of the abdomen, for non-invasive assessment of liver iron deposition. In this work, study team will develop and optimize advanced data acquisition and image reconstruction methods to enable QSM of the abdomen. Further, investigators will determine the accuracy, repeatability, and reproducibility of abdominal QSM for iron quantification in patients with liver iron overload.

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. Accurate assessment of liver iron concentration is critical for the detection and staging of iron overload as well as for longitudinal monitoring during treatment.

In summary, this project will develop a novel MRI-based QSM technique designed for the abdomen and will validate it in pediatric and adult patients with liver iron overload. Upon successful validation, QSM will provide accurate, repeatable, and reproducible quantification of LIC based on a fundamental property of tissue.

Enrollment

63 patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ages 10 years or older at University of Wisconsin - Madison
  • Age 5 years or older at Stanford
  • Known or suspected iron overload

Exclusion criteria

  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, etc)

  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)

  • Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the MRI will be allowed to participate as long as the following criteria are met:

    • The subject has their own prescription for the medication.
    • The informed consent process is conducted prior to the self-administration of this medication
    • They come to the research visit with a driver

Trial design

63 participants in 1 patient group

MRI based abdominal QSM
Description:
Participants with known or suspected iron overload with past serum ferritin \>500 will be recruited in this study.
Treatment:
Radiation: Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)

Trial contacts and locations

2

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Central trial contact

Study Coordinator

Data sourced from clinicaltrials.gov

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