RecruitingNCT05294471

Fully Automated High-Throughput Quantitative MRI of the Liver


Sponsor

University of Wisconsin, Madison

Enrollment

200 participants

Start Date

Oct 16, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

The purpose of this research is to see if a new automated magnetic resonance imaging (MRI) method will be able to improve the images taken of the liver. Participants will have either known or suspected liver disease, known or suspected iron overload syndrome, or be a healthy adult. Participants will be in the research study for one day.


Eligibility

Min Age: 7 Years

Inclusion Criteria8

  • Eligibility Criteria for Substudies 1, 2, 4, 5
  • Age 18 years or older
  • Age 7 years or older
  • One of:
  • Known or suspected liver iron overload
  • Known or suspected elevated liver fat
  • Age 7 years or older
  • Scheduled for a clinical abdominal MRI exam

Exclusion Criteria13

  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
  • Eligibility Criteria for Substudy 3
  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
  • 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
  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)
  • Eligibility Criteria for Substudy 6
  • Patients with contraindication to MRI (e.g. pacemaker, contraindicated metallic implants, claustrophobia, etc)
  • Sedation required for MRI
  • Pregnant or trying to become pregnant (as determined by self-report during MRI safety screening)

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Interventions

DEVICENon-contrast MRI with novel MRI software

The investigational software being used in automatic prescription of the imaging is an application of an AI algorithm. This software prescribes where the MRI system will take images by finding the liver within a set of localizer scans. The software gives coordinates to the scanner.


Locations(1)

University of Wisconsin

Madison, Wisconsin, United States

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NCT05294471


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