Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
63 participants
OBSERVATIONAL
2022-01-18
2024-04-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MRI based abdominal QSM
Participants with known or suspected iron overload with past serum ferritin \>500 will be recruited in this study.
Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)
MRI-based QSM methods estimate the susceptibility of tissues based on measuring the magnetic field distortion produced by the tissues themselves.
Upon successful validation, MRI-based abdominal QSM will provide accurate, repeatable, and reproducible quantification of Liver iron concentration (LIC) that is independent of the distribution of iron and does not require calibration.
Interventions
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Magnetic Resonance Imaging (MRI)-based Quantitative Susceptibility Mapping (QSM)
MRI-based QSM methods estimate the susceptibility of tissues based on measuring the magnetic field distortion produced by the tissues themselves.
Upon successful validation, MRI-based abdominal QSM will provide accurate, repeatable, and reproducible quantification of Liver iron concentration (LIC) that is independent of the distribution of iron and does not require calibration.
Eligibility Criteria
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Inclusion Criteria
* Age 5 years or older at Stanford
* Known or suspected iron overload
Exclusion Criteria
* 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
5 Years
ALL
No
Sponsors
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Stanford University
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Diego Hernando, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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School of Medicine, Stanford University
Stanford, California, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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A539300
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/RADIOLOGY/RADIOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 9/10/2021
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0761
Identifier Type: -
Identifier Source: org_study_id
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