Fully Automated High-Throughput Quantitative MRI of the Liver

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05294471
Status
Recruiting
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Conditions

  • Healthy
  • Iron Overload
  • Liver Fat

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Non-contrast MRI with novel MRI software — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 16, 2023
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Healthy participants
    70 healthy participants will be recruited, across substudies 1, 2, 4, and 5
  • Arm: Participants with known or suspected iron overload
    30 Participants with known or suspected iron overload will be recruited, to substudy 3
  • Arm: Participants with elevated levels of liver fat
    30 participants with elevated levels of liver fat will be recruited, to substudy 3
  • Arm: Participants referred for clinical abdominal MRI
    60 participants referred for clinical abdominal MRI will be recruited, to substudy 6

Primary Outcome Measure

Confirm the accuracy (ie: bias) of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload [ Time Frame: 1 day (1 study visit, up to 3.5 hours) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Scott Reeder, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Wisconsin· Madison, WI

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