MRI QSM Imaging for Iron Overload

NCT ID: NCT04631718

Last Updated: 2024-05-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-18

Study Completion Date

2024-04-29

Brief Summary

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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.

Detailed Description

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Conditions

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Hemochromatosis Iron Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type RADIATION

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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK117354-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

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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