Fully Automated High-Throughput Quantitative MRI of the Liver

NCT05294471 | Recruiting DMC FDA Device

• 5 other identifiers: 2021-1615A539300SMPH/RADIOLOGY/RADIOLOGY2/18/20251R01EB031886-01A1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Confirm the accuracy (ie: bias) of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload

  For each liver segment, and for whole-liver PDFF and R2\* measurements, we will determine bias of CSE 2D using CSE 3D BH as the reference from Bland-Altman analysis. The range of R2\* values leading to reliable measurements of PDFF and R2\* will be determined using a two-segment piecewise linear model with the change point estimated from the data.

  1 day (1 study visit, up to 3.5 hours)

Secondary Outcomes (5)

• Image quality of free breathing 2D chemical shift encoded (CSE) method

  1 day (1 study visit, up to 3.5 hours)

• Measure the repeatability of the proposed CSE-MRI method in patients with liver steatosis and in patients with liver iron overload

  1 day (1 study visit, up to 3.5 hours)

• Confirm the reproducibility of the proposed CSE-MRI method across field strengths

  1 day (1 study visit, up to 3.5 hours)

• Technical success rate of the integrated single-button push, fully automated CSE-MRI protocol in < 5 minutes of MR room time

  1 day (1 study visit, up to 3.5 hours)

• Mean and standard deviation of total two-door suite time for the single-push button exam

  1 day (1 study visit, up to 3.5 hours)

Study Arms (4)

Healthy participants

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

Device: Non-contrast MRI with novel MRI software

Participants with known or suspected iron overload

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

Device: Non-contrast MRI with novel MRI software

Participants with elevated levels of liver fat

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

Device: Non-contrast MRI with novel MRI software

Participants referred for clinical abdominal MRI

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

Device: Non-contrast MRI with novel MRI software

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.

Healthy participants; Participants referred for clinical abdominal MRI; Participants with elevated levels of liver fat; Participants with known or suspected iron overload

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers will be recruited from the "MRI Volunteer Database", and/or UW - Madison employees. Participants with liver fat or liver iron will be recruited from relevant UW Clinics.

You may qualify if:

• Age 18 years or older

You may not qualify if:

• 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
• Age 7 years or older
• One of:
• Known or suspected liver iron overload
• Known or suspected elevated liver fat
• 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
• Age 7 years or older

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Iron Overload; Fatty Liver

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases

Study Officials

• Scott Reeder, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; radstudy@uwhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: October 16, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)