Recruiting

MRI

Sponsor:

University of Wisconsin, Madison

Code:

NCT05294471

Conditions

Healthy

Iron Overload

Liver Fat

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

Interventions

Non-contrast MRI with novel MRI software

Study Details

Brief 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.

Conditions

Healthy

Iron Overload

Liver Fat

Study ID

NCT05294471

Start date

Oct 16, 2023

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

Eligibility Criteria for Substudies 1, 2, 4, 5

Inclusion Criteria:

  • Age 18 years or older

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • Age 7 years or older
  • One of:

  • Known or suspected liver iron overload
  • Known or suspected elevated liver fat

Exclusion Criteria:

  • 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

Inclusion Criteria:

  • Age 7 years or older
  • Scheduled for a clinical abdominal MRI exam

Exclusion Criteria:

  • 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)

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy participants

70 healthy participants will be recruited, across substudies 1, 2, 4, and 5

Participants with known or suspected iron overload

30 Participants with known or suspected iron overload will be recruited, to substudy 3

Participants with elevated levels of liver fat

30 participants with elevated levels of liver fat will be recruited, to substudy 3

Participants referred for clinical abdominal MRI

60 participants referred for clinical abdominal MRI will be recruited, to substudy 6

Interventions

Non-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.

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 and Locations

Central contacts

Radiology Studies

608-282-8349radstudy@uwhealth.org

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Principal Investigator:

Scott Reeder, MD, PhD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-03-12.